<![CDATA[Legacy MedSearch: jobboards]]> http://JOBS.LEGACYMEDSEARCH.COM/ en-us <![CDATA[Senior Clinical Trial Manager]]> Responsibilities: 

  • Own and manage all aspects of trial start-up, conduct, and closeout activities
     
  • Lead all clinical site interactions (including assistance with IRB/EC applications, contract negotiations, enrollment tracking, clinical trial material requests, issue resolution, etc.)

Must Have:

  • 8+ Years experience monitoring & managing clinical trials in medical device (preferred), pharmaceutical drug development, biotech, or with a CRO 
     
  • Proven expertise in executing IRB/EC submissions & approvals
     
  • Outstanding track record leading large complex global clinical trials for medical device products in different phases of the product cycle in a hands on capacity

Travel: 25% 
Compensation: Competitive 
Education: BS/BA

]]>
Mon, 17 Sep 2018 00:00:00 EDT 1
<![CDATA[Senior Supplier Quality Engineer]]> Responsibilities: 

  • Monitor supplier performance and drive improvement and resolution of non-conformances directly with supplier through corrective action process
     
  • Increase number of source inspections and dock-to-stock items
     
  • Establish and report on supplier Key Performance Indicators
     
  • Manage the approved supplier list and supplier audit schedule

Must Have:

  • 8+ Years experience in a medical device manufacturing environment with at least 2 years in supplier quality. Relevant MS highly preferred
     
  • Lead auditor experience (Internal or Supplier auditing)
     
  • Working knowledge and practical application of ISO 13485, 21 CFR Part 820, and ISO 9001
     
  • Identify and implement improvements to supplier selection and incoming inspection processes

Travel: 10%
Compensation: Commensurate to Experience
Education: BS - MS Preferred

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Thu, 13 Sep 2018 00:00:00 EDT 0
<![CDATA[Senior Quality Engineer - Complaints/Post-Market]]> Responsibilities: 

  • Own and manage all aspects of trial startup, conduct, and closeout activities
     
  • Lead all clinical site interactions (including assistance with IRB/EC applications, contract negotiations, enrollment tracking, clinical trial material requests, issue resolution, etc.)

Must Have:

  • 8+ Years experience monitoring & managing clinical trials in medical device (preferred), pharmaceutical drug development, biotech, or with a CRO 
     
  • Proven expertise in executing IRB/EC submissions & approvals
     
  • Outstanding track record leading large complex global clinical trails for medical device products in different phases of the product cycle in a hands on capacity

Travel: 10%
Compensation: Commensurate to Experience
Education: B.S. - M.S. Preferred

]]>
Thu, 13 Sep 2018 00:00:00 EDT 0
<![CDATA[Vice President, Engineering]]> Responsibilities: 

  • Direct all engineering functions within the company including product development, process engineering, and technical support
     
  • Maintain competitive advantage by cultivating an industry leading engineering team and identifying applicable new technologies
     
  • Oversee the technical portion of all new quotes and design proposals

Must Have:

  • Significant experience managing a diverse team of design, manufacturing, and quality engineers
     
  • Extensive technical knowledge of precision component manufacturing (plastics and metal), innovative automation and robotics, and continuous process improvement
     
  • In-depth knowledge of engineering contributions to overall business plan 

Travel: 60%
Compensation: $150K+ Bonus
Education: BS - MBA or MS Preferred

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Tue, 11 Sep 2018 00:00:00 EDT 0
<![CDATA[Marketing Manager]]> Responsibilities: 

  • Build and develop strategic marketing initiatives, as well as launch new iteration of the technology
     
  • Manage all pre & post launch strategic downstream marketing
     
  • Enhance digital strategy and develop lead and demand generation campaign
     
  • Build external sales team tools, such as ROI calculator, qualification guide, and additional sales collateral 

Must Have:

  • Strong experience in downstream marketing of surgical technology
     
  • Previous successful track record of developing marketing messages, brand image, and full product launches
     
  • Strong preference for prior experience with highly advanced technology

Travel: 30%+
Compensation: Commensurate to Experience
Education: BA - MBA Preferred

]]>
Tue, 11 Sep 2018 00:00:00 EDT 1
<![CDATA[Vice President of Clinical Affairs]]> Responsibilities: 

  • Provide leadership in designing and executing clinical studies including protocol development, investigator selection training and clinical operations
     
  • Reporting to the President & CEO

Must Have:

  • 10+ Years of Clinical experience within the Medical Device space
     
  • Track record of developing strategy and executing operational plans
     
  • Significant medical device leadership experience at director level or above
     
  • Roll Up Your Sleeves Mentality - previous startup experience a plus
     
  • Desire to make a difference for patients

Travel: Variable
Compensation: Competitive + Equity
Education: BS - MD Highly Preferred

]]>
Wed, 05 Sep 2018 00:00:00 EDT 0
<![CDATA[Senior Product Manager - Spine]]> Responsibilities: 

  • Early Concept to commercial launch of new products as well as line extensions in full portfolio
     
  • Create and drive market adoption of new technology and existing product portfolio
     
  • Strong upstream & downstream marketing experience in spinal implants

Must Have:

  • 5 to 10+ Years in Spinal Implant or Spinal Device Marketing
     
  • Strong cross functional leadership experience in a fast paced environment
     
  • Preference for documentable successful product launches with responsibility from concept to commercial

Travel: 30%+
Compensation: Commensurate to Experience
Education: Bachelors - MBA Preferred

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Mon, 03 Sep 2018 00:00:00 EDT 0
<![CDATA[Regional Sales Manager - Disruptive Capital Equipment]]> Responsibilities: 

  • Continued development and acceleration of system sales in the region
     
  • Develop and leverage KOL champions and C-suite relationships to accelerate the capital sales cycle
     
  • Penetrate net new accounts within region while managing clinical support of existing systems

Must Have:

  • 7+ Years in high ticket medical device capital equipment sales
     
  • Strong, documentable track record of capital sales success
     
  • Clinical experience in Neuro, Spine, ENT, Cranial, MRI/CT, or disruptive medical technology is highly preferred 

Travel: 40%+
Compensation: $250K+
Education: Bachelors

]]>
Mon, 03 Sep 2018 00:00:00 EDT 0
<![CDATA[Senior Product Development - Engineer]]> Responsibilities: 

  • New product development and additional line extensions of current and new portfolio iterations
     
  • Work cross functionally to develop new product in advances portfolio
     
  • Work with design surgeons and define project plan to commercial launch

Must Have:

  • 5 to 7+ Years experience in medical device product development
     
  • Concept to commercial spinal implant design experience
     
  • Strong CAD skills and project management experience

Travel: 10%
Compensation: Competitive
Education: B.S.

]]>
Thu, 30 Aug 2018 00:00:00 EDT 0
<![CDATA[Director of Quality]]> Responsibilities: 

  • Define strategic direction of entire quality department while delegating resources efficiently
     
  • Act as Player Coach, leading from the front in continuing to hone & develop QMS and manufacturing quality
     
  • Ability to define and analyze process improvement, as well as impact and build corporate culture

Must Have:

  • 10+ Years in progressive quality leadership with capacity and drive for continued career advancement
     
  • Strong, documentable experience in ISO 13485 regulated facilities & global quality system management
     
  • Strong preference for orthopedic, spinal, or medical device implant experience

Travel: 20%
Compensation: Highly Competitive - Equity Potential 
Education: B.S. - M.S. Preferred

]]>
Thu, 30 Aug 2018 00:00:00 EDT 0
<![CDATA[Director of Marketing - Spine]]> Responsibilities: 

  • Lead team in strategic and tactical product launches
     
  • Define roadmap to success for both existing and new products
     
  • Strong ability to think creatively and enhance existing cultural environment by creating a culture of success

Must Have:

  • 15+ Years in marketing spinal technologies
     
  • Strong experience in a myriad of products launched with a strong track record of both upstream and downstream marketing experience
     
  • Strong organizational and strategic leadership ability 

Travel: 40%+
Compensation: Competitive 
Education: Bachelors, MBA Preferred

]]>
Wed, 29 Aug 2018 00:00:00 EDT 0
<![CDATA[Regional Sales Director West]]>    

US Sales Director West, US

Position Overview

You will be 1 of  2 Leaders nationally for a fast growing disruptive Cardiovascular  Medical Device company seeking entrepreneurial Sales Director to build and grow a high performing and rapidly growing sales force. This entrepreneurial organization has a developed portfolio to address and unmet clinical need, and in the process of accelerating commercial expansion. Ideal candidates will have strong leadership qualities in managing though a fast-paced environment, the ability to be a player coach, sales process orientation, and experience selling clinically validated conceptional technology that changes the paradigm of physician thought process. 


Position Requirements

  • 10+ years medical sales and sales management experience – preferably in a disruptive technology.
  • Previous experience in hiring managing and training commercial team.
  • Strategic region development, and proven track record of growth
  • Strong capacity to develop sales process and develop corporate culture.
  • A combination of both start-up med device and pedigree company sales experience is ideal
  • Previous experience in strategic planning, forecasting, and budgeting.
  • Ability to travel 60%

Educational Requirements

  • Bachelor's degree minimum from an accredited 4 year university


Base Salary :  $240k + at plan uncapped +equity
Estimated Travel: 60%

Direct Reports : 6 to grow to 10

Recruiter:  Joy Celebre

Recruiter Phone : 407-591-3024

 

]]>
Tue, 28 Aug 2018 00:00:00 EDT 0
<![CDATA[Regional Sales Manager - Midwest]]> Responsibilities: 

  • Manage a strong growing team (20%+ annually) of direct sales representatives with a focus on developing talent
  • Responsible for training and reinforcing strategic selling techniques including clinical selling, mentoring, leading, and motivating sales representatives
  • Accompany sales team on contract negotiations as needed

Must Have:

  • Strong, positive relationships with surgeons and/or surgery personnel and experience supporting surgeons during complex procedures
  • Extensive experience developing and managing strategic plans for growth
  • Strong understanding of human anatomy & physiology
]]>
Mon, 27 Aug 2018 00:00:00 EDT 0
<![CDATA[Regional Sales Manager | Minneapolis - Growth Role!]]> Regional Sales Manager  | Confidential Posting

Due to the confidential nature of this position, please contact the recruiter for further information.  Joy@legacymedsearch.com

Position Summary

As an RSM your primary goal is to provide company sales products within specified region or major geographical area and to provide support to product distribution channel.

Must have experience in the following:

  • 3+ years in medical Device
  • Ability to travel
  • Start up experience a plus
  • CRM/EP experience highly preferred

Base: 80k year one 110k to 135k year two 145k to 195k

Travel: 30%

Years of experience: 3+ years in Medical Device

Degree: Bachelor’s from accredited 4 year university

Location: Minneapolis 

]]>
Mon, 27 Aug 2018 00:00:00 EDT 1
<![CDATA[Regional Sales Manager | Phoenix - Growth Role!]]> Regional Sales Manager  | Confidential Posting

Due to the confidential nature of this position, please contact the recruiter for further information.  Joy@legacymedsearch.com

Position Summary

As an RSM your primary goal is to provide company sales products within specified region or major geographical area and to provide support to product distribution channel.

Must have experience in the following:

  • 3+ years in medical Device
  • Ability to travel
  • Start up experience a plus
  • CRM/EP experience highly preferred

Base: 80k year one 110k to 135k year two 145k to 195k

Travel: 30%

Years of experience: 3+ years in Medical Device

Degree: Bachelor’s from accredited 4 year university

Location: Phoenix 

]]>
Mon, 27 Aug 2018 00:00:00 EDT 1
<![CDATA[Senior Marketing Manager]]> Responsibilities:

  • Own product management lifecycle from feasibility to post-commercialization
  • Work closely with VP of Marketing and VP of Business Dev to develop strategic plans for growth
  • Key clinical point of contact for cross functional teams, making recommendations for improvement

Must Have:

  • 8+  Years in a marketing/product management or commercial focused role
  • Upstream & Downstream Marketing experience, with exposure to Marcom, Sales Training, Forecasting, and Tradeshows
  • Experience working in a collaborative, entrepreneurial environment
]]>
Fri, 24 Aug 2018 00:00:00 EDT 0
<![CDATA[Vice President of Operations East Coast]]> Responsibilities:

  • Manage a team of 10+ Direct Reports with over 100 Indirect Reports
  • Key member of leadership team across multiple sites

Must Have:

  • 7+ Years of Manufacturing Operations Leadership experience
  • Six Sigma or Lean experience within a medical device company
  • Clean Room experience
]]>
Fri, 24 Aug 2018 00:00:00 EDT 0
<![CDATA[Director of Marketing - Orthopedics]]> Responsibilities

  • Analyze current product portfolio and properly position in the market
  • Prioritize and strategically plan current and upcoming product launches and releases
  • Utilize tactical execution and resource allocation to enhance the brand
  • Interact with KOL surgeon user group to provide VOC to executive leadership

Must Have:

  • 8 to 15+ Years in Orthopedic marketing
  • Verifiable history of success in upstream and downstream marketing
  • Documented record of successful product launches and releases
]]>
Fri, 17 Aug 2018 00:00:00 EDT 0
<![CDATA[Director of Marketing Communications]]> Responsibilities: 

  • Global Marcom Initiatives including sales collateral, trade shows, campaigns, social site presence, public relations, product launches, regulatory communications and corporate events

Must Have: 

  • Experience working in a fast paced, roll up your sleeves environment
  • Experience in a high energy, collaborative environment working with graphic designers, communications & media specialists, and copywriters. 
  • 5+ years Marketing Communications experience with outstanding writing and project management skills
]]>
Tue, 14 Aug 2018 00:00:00 EDT 0
<![CDATA[Field Service Engineer]]> Must Have:

  • 5+ years experience providing field service for complex Medical Devices in hospital settings
  • Ability to travel 50% within the US and OUS

Responsibilities: 

  • Installation of complex electromechanical Medical Device systems
  • Driving customer satisfaction through service excellence
  • Complete preventative maintenance, troubleshooting, and customer needs analysis in a professional manner
]]>
Tue, 07 Aug 2018 00:00:00 EDT 0
<![CDATA[National Account Manager]]>

Must Have:

  • 5+ years relationships with major IDNs, IHNs, GPOs, and Government
  • 10+ years in complex medical technology sales
  • Strong understanding of reimbursement, pricing, contract negotiation

Responsibilities:

  • Lead the company's strategic corporate contract initiatives
  • Provide guidance to sales & marketing on capitalizing on contracts
  • Strategic selling to Vizient, Premier, HPG, Kaiser, Adventist, etc.

 

]]>
Thu, 02 Aug 2018 00:00:00 EDT 0
<![CDATA[VP of Marketing]]>

Must Have:

  • 15+ years of experience in medical device marketing
  • Strong downstream experience with KOL, Hospital, & Patient Marketing
  • Prior consumer experience building patient "communities"
  • Ability to thrive in a fast paced environment working with complex technology

Responsibilities: 

  • Lead marketing efforts for high performing commercial team
  • Message technology benefits to multiple clinical areas and functions
]]>
Thu, 02 Aug 2018 00:00:00 EDT 0
<![CDATA[Special Advisor to the CEO]]>

Must Have:

  • PEG, VC, IB, or Consulting Background (Healthcare Strategy, Financial Modelling) 
  • Strong understanding of reimbursement, regulatory challenges. 
  • Analysis of IP, M&A, acquisition strategy

Responsibilities: 

  • Accompany CEO to high-level meetings and provide input on special projects
  • Perform financial and business analysis on potential investments, reimbursement
]]>
Thu, 02 Aug 2018 00:00:00 EDT 0
<![CDATA[Regional Sales Manager-TX]]>

Must Have:

  • High dollar capital equipment sales experience - minimum ASP of $500K
  • Assertive hunter mentality, financially motivated with strong principles
  • Documentable previous income of $300k+ for minimum 2 years

Responsibilities:

  • Sell newly FDA approved & reimbursed therapeutic imaging device
  • Manage complex capital sales process effectively through all stages
  • Be part of early adoption in multiple clinical areas

 

]]>
Wed, 01 Aug 2018 00:00:00 EDT 0
<![CDATA[Regional Sales Manager-Mid-Atlanic]]>

Must Have:

  • High dollar capital equipment sales experience - minimum ASP of $500K
  • Assertive hunter mentality, financially motivated with strong principles
  • Documentable previous income of $300k+ for minimum 2 years

Responsibilities:

  • Sell newly FDA approved & reimbursed therapeutic imaging device
  • Manage complex capital sales process effectively through all stages
  • Be part of early adoption in multiple clinical areas
]]>
Wed, 01 Aug 2018 00:00:00 EDT 0
<![CDATA[Regulatory Specialist - Hip]]> Position Overview

As a regulatory specialist for a major Orthopedics manufacturer you will prepare and maintain FDA & international product registrations for medical devices.

Primary Responsibilities:

  • Ensure that all procedures, processes, and documentation meet guidelines for FDA compliance, including Design Control & Risk Management processes
     
  • Prepare & Maintain FDA pre-market submissions as well as international product registrations
     
  • Prepare & Maintain CE Mark Design Dossiers and Technical File for review by the Notified Body
     
  • Provide regulatory support for new product development process
     
  • Participate in complaint handling process, internal quality audit process, and CAPA activities.
     
  • Review and approve product labelling
     
  • Provide support and guidance for other employees as necessary

Position Requirements:

  • 2+ Years Experience in FDA/ISO Medical Device Quality Management Systems
     
  • Experience in preparing FDA pre-market submissions (whether 510(k) and/or PMA) and international registrations highly preferred
     
  • Nuanced understanding in Design Control

Education Requirements:

  • Bachelors 

Location: Southeast

Compensation: Commensurate with Experience

]]>
Thu, 12 Jul 2018 00:00:00 EDT 0
<![CDATA[Regulatory Specialist - Knee]]>

Position Overview

As a regulatory specialist for a major Orthopedics manufacturer you will prepare and maintain FDA & international product registrations for medical devices.

Primary Responsibilities:

  • Ensure that all procedures, processes, and documentation meet guidelines for FDA compliance, including Design Control & Risk Management processes
     
  • Prepare & Maintain FDA pre-market submissions as well as international product registrations
     
  • Prepare & Maintain CE Mark Design Dossiers and Technical File for review by the Notified Body
     
  • Provide regulatory support for new product development process
     
  • Participate in complaint handling process, internal quality audit process, and CAPA activities.
     
  • Review and approve product labelling
     
  • Provide support and guidance for other employees as necessary

Position Requirements:

  • 2+ Years Experience in FDA/ISO Medical Device Quality Management Systems
     
  • Experience in preparing FDA pre-market submissions (whether 510(k) and/or PMA) and international registrations highly preferred
     
  • Nuanced understanding in Design Control

Education Requirements:

  • Bachelors 

Location: Southeast

Compensation: Commensurate with Experience

]]>
Thu, 12 Jul 2018 00:00:00 EDT FDA pre-market submissions (510(k)

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1
<![CDATA[Regulatory Specialist - Shoulder]]> Position Overview

As a regulatory specialist for a major Orthopedics manufacturer you will prepare and maintain FDA & international product registrations for medical devices.

Primary Responsibilities:

  • Ensure that all procedures, processes, and documentation meet guidelines for FDA compliance, including Design Control & Risk Management processes
     
  • Prepare & Maintain FDA pre-market submissions as well as international product registrations
     
  • Prepare & Maintain CE Mark Design Dossiers and Technical File for review by the Notified Body
     
  • Provide regulatory support for new product development process
     
  • Participate in complaint handling process, internal quality audit process, and CAPA activities.
     
  • Review and approve product labelling
     
  • Provide support and guidance for other employees as necessary

Position Requirements:

  • 2+ Years Experience in FDA/ISO Medical Device Quality Management Systems
     
  • Experience in preparing FDA pre-market submissions (whether 510(k) and/or PMA) and international registrations highly preferred
     
  • Nuanced understanding in Design Control

Education Requirements:

  • Bachelors 

Location: Southeast

Compensation: Commensurate with Experience

 

]]>
Thu, 12 Jul 2018 00:00:00 EDT FDA pre-market submissions (510(k)

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1
<![CDATA[Logistics Manager]]> Position Overview

The Logistics Manager with a late-stage startup in the cardiology field will be responsible for implementing new and efficient processes for both internal and external customers in regards to product movement and order fulfillment.

Primary Responsibilities:

  • Develop and implement streamlined processes from order intake to shipment/delivery
     
  • Implement a long-term process improvement path to simplify and improve logistics processes
     
  • Work alongside the Operations team in the management of freight and packaging issues
     
  • Establish, track, and report on all key metrics related to order fulfillment and customer service
     
  • Primary contact with all global logistics and distribution partners – develop and help to implement improved logistics processes for all international European distribution partners
     
  • Full process ownership for all customer returns, internal lab orders, and logistics associated with field service

Requirements:

  • 5+ Years of experience in Logistics/Operations, with at least 2 in medical device
     
  • Experience developing and implementing logistics process improvements

Education Requirements: Bachelors

Location: Greater Boston Area

Compensation: Competitive

 

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Thu, 12 Jul 2018 00:00:00 EDT 0
<![CDATA[Manufacturing Engineer]]> Position Summary:
 
Due to rapid growth our client is looking to add to their team in Boston, MA. The ideal candidate for this position must have excellent communication skills and a strong desire to succeed.  If you are looking for a forward-thinking and entrepreneurial culture, you thrive on challenges and you are passionate about saving lives we want to talk to you!

 

Position Responsibilities: 

  • Process oversight and Sustaining Engineering.
  • Working with Engineering team to introduce new products into production including leading Process Development and Process Validation activities related to Disposable and Hardware production.
  • Creation of Production Documentation including Manufacturing, Inspection and Test Instructions.
  • Selection, design, installation and maintenance of Equipment, Tooling and fixtures used in Production.
  • Identification of opportunities to streamline production processes to remove inefficiencies and ensure highest product quality.
  • Training Production team in Manufacturing Instructions.
  • Performing all Equipment Maintenance on all Prodution Equipment.
  • Working with Production Team, Quality Assurance and Design Engineering to identify and resolve technical and quality related issues identified in production.
  • Supporting all facility related activities for maintaining the Production areas.

 

Position Requirements:

  • BS in Engineering plus 1-3 years experience working in a Manufacturing Environment.
  • Must have manufacturing experience in FDA/ISO regulated Medical Device/ Medical Equipment Industry.
  • Must have prior Process Development and/or Manufacturing Engineering experience including the development and execution of Process Validation plans.
  • Must be detail oriented with strong organizational skills.
  • Strong interpersonal skills with willingness to be held accountable for deliverables.
  • Outstanding ability to communicate clearly and effectively.
  • Must have effective analytical and decision making skills.
  • Proven track record of working in a fast-paced environment with demonstrated ability to adjust to changing priorities.
  • Lean Six Sigma experience and knowledge of statistical data analysis techniques is a plus.

 

 

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Wed, 27 Jun 2018 00:00:00 EDT 0
<![CDATA[Process Quality Engineer]]> Position Summary:

Our client. is currently looking for a highly motivated Process Quality Engineer to join our team and help revolutionize transplant medicine.  Based at our headquarters, this is a hands-on role in a fast-paced and dynamic medical device company.

Position Responsibilities:

  • Support day-to-day manufacturing activities.
  • Lead efforts to identify and resolve manufacturing non-conformances (containment, root cause investigation, corrective action).
  • Support process validation activities.
  • Support new product development programs.
  • Support/lead investigations of complaints due to manufacturing defects.
  • Support internal audit and manufacturing GMP/ISO 13485 audit programs.
  • Lead/assist with manufacturing Corrective and Preventive Actions (CAPA).
  • Identify product and process improvements; lead or support their implementation.
  • Create production documentation including manufacturing, inspection and test instructions.
  • Support training program for production team and quality inspectors.
  • Perform other tasks and duties as required.

Position Requirements:

  • BS in Engineering or related discipline with 5-10 years of experience as a Quality/Manufacturing Engineer in the medical device manufacturing industry including 2+ years supporting manufacturing of consumable/disposable products.
  • Thorough knowledge and understanding of FDA QSR and ISO 13485 regulations.
  • Experience in medical device manufacturing and EtO sterilization of disposable medical devices.
  • Experience leading or supporting process validation activities.
  • Thorough understanding of basic statistics and experience using Minitab (or similar statistical software packages).
  • Ability to define problems, collect and analyze data, and draw valid conclusions.
  • Ability to communicate ideas and information clearly, effectively and concisely.
  • Highly detailed oriented with strong organization and prioritization skills.
  • Must possess a high level of energy with the ability to handle multiple projects and changing priorities.
  • Must be results-driven and exhibit a sense of urgency.
  • Lean Six Sigma training/certification is a plus.

 

 

 

 

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Tue, 26 Jun 2018 00:00:00 EDT 0
<![CDATA[Regulatory Affairs Manager]]> Position Summary:

The Regulatory and Clinical Affairs Manager will be responsible for hands on contribution, cross functionally, towards gaining regulatory acceptance for products currently in the pipeline and future products.  

  • Degree in Engineering or Life Sciences
  • Minimum 3 years working in Regulatory Affairs in the Medical Device Industry
  • Experience in Ophthalmology is a plus
  • Knowledge of creating and writing 510(k) dossiers and managing a complete 510(k) registration process
  • Knowledge of FDA regulations
  • Knowledge of IEC 60601-1 Family, IEC 62304, IEC 60825 and ISO 14971
  • Excellent interpersonal skills
  • Ability to travel domestically and globally occasionally (30%)

*Due to the confidential nature of this position, please contact Joy Celebre for further information.


Location: Massachussetts

Position Reports To: VP Regulatory

Compensation: Commensurate

Travel: International

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Thu, 21 Jun 2018 00:00:00 EDT 1
<![CDATA[Senior Manufacturing Engineer]]> Senior Manufacturing Process Engineering

We are currently recruiting for a Senior Manufacturing Process Engineering role. Reporting to the Director of Manufacturing, this is an excellent opportunity for an individual who is ambitious, hardworking, and wants to contribute to the future of healthcare.   

Position Responsibilities:

  • Oversee the manufacturing processes of Catheters to ensure workflows are smooth and efficient;
  • Design, document, and provision the manufacturing processes for the transfer of the Catheters into production and ramping volumes;
  • Provide guidance and share experiences with Manufacturing Process Engineering Team;
  • Collaborate with design engineers to implement “design for manufacturing”;
  • Design/fabricate or select tooling, automation, and test equipment for the manufacturing processes;
  • Establish control and calibration procedures and protocols for tooling, automation, and test equipment to ensure that procedures and protocols are followed to deliver a quality product;
  • Establish process control points in the manufacturing process and establish testing requirements and procedures; develop and ensure maintenance of statistical controls;
  • Train and support production technicians on the day-to-day manufacturing to establish and maintain a smooth and efficient workflow;
  • Collaborate with suppliers of outsourced parts, assemblies, and products, to resolve pertinent quality issues;
  • Participate in Corrective Action and Preventative Action Teams, lead product failure investigations both internally and externally, and design and perform “design of experiments” techniques to establish root cause failure modes;
  • Assist in validation and verification of production processes and manage validation resources, prepare and present validation and verification reports to meet ISO 13485 requirements;
  • Adhere to ISO 13485 guidelines and ensure product compliance to all applicable agency codes;
  • Recommend/evaluate/implement opportunities for continuous process and product improvement and lead “Lean Manufacturing” initiatives to improve production rates and quality of output;
  • Support EHS activities and initiatives to comply with safety regulations;
  • Support any other initiatives or projects as requested.

Position Requirements:

  • B.Sc./M.Sc. in Mechanical Engineering;
  • Preferred, minimum 7 years of experience working as a manufacturing process engineer in catheter manufacturing;
  • Working knowledge of ISO 13485 standard;
  • Excellent written and verbal communication skills to be able to communicate effectively with technical and non-technical personnel.
  • Employs a results-oriented work style and teamwork-oriented approach to meeting objectives;
  • Demonstrates the ability to prioritize duties, multi-task, and quickly assume new tasks to function productively in a fast-paced environment;
  • Possess excellent attention to detail to ensure accuracy;
  • Proficient use of MS Word and Excel to prepare memos and reports;
  • Able to travel infrequently, as required.

Recruiter: Arshad Alam
Recruiter Phone: 407-591-3030
Recruiter email: Arshad@LegacyMedSearch.com

 

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Tue, 19 Jun 2018 00:00:00 EDT 0
<![CDATA[Product Development Engineer - Extremities]]>

Position Summary

The Product Development Engineer will be responsible for the creation of Orthopedic implants and instrument product lines, new product development, and maintenance.  Hands-on involvement with all phases of medical device development of Orthopedic Implantable Devices, fabrication of prototypes and instrumentation will be required.  They will be involved with all aspects of designing, executing, and analyzing experiments, as well as verify and validating tests using statistical techniques. This company is a well-established orthopedics implant and instrument organization with targeted high growth potential and gaining market share.


Primary Responsibilities

  • Orthopedic product development including implants and instrumentation.
     
  • Creation of documentation consistent with design control procedures.
     
  • Hands on involvement (full-cycle) from initial concept to launch.
     
  • Verify and validate tests using statistical techniques
  • Provide support to sales and marketing efforts as well as interact with design surgeons
  • Guide material management, inspection, and manufacturing process of select products

 

Position Requirements

  • 3 to 7+ years of experience in orthopedic product development including implants and instrumentation (Shoulder, Extremities, Upper extremity Trauma)
  • Candidate must be experienced with full lifecycle manufacturing processes
     
  • Experience with GMP, FDA, and ISO requirements
     
  • Strong engineering, design, and analysis skills
  • Working knowledge of CAD (ProE or equivalent)
  • Experience with design history, validations, and testing
  • Project management skills highly desired

 

Education Requirements

  • BS Engineering Mechanical, Biomedical or Equivalent. 
     
  • MS+ preferred

Location: South East

Compensation: Commensurate with experience

NOTE: This job description is not intended to be all-inclusive and may have been abbreviated or maximized for online or mobile viewing. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization. 

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Tue, 22 May 2018 00:00:00 EDT 0
<![CDATA[Account Manager - Surgical Capital Equipment]]> Account Manager- Surgical Capital Equipment

Position Overview

This entrepreneurial organization is commercializing and accelerating growth with an innovative product portfolio, and is seeking a dynamic sales representative to mange the Boston market. We are seeking an individual who has a strong track record of exceeding high end sales goals and has worked to roll out and developed a region with advanced technology. Ideal individuals will have track record sales success in a complex sales cycles. The individual must be an autonomous sales professional, who can operate independently and think strategically, in order to analyze business concepts to develop, grow, expand market penetration.
 


Primary Responsibilities

  • Manage individual objective for key geography
  • Prospect for new business by identifying and qualifying sales leads generated from referrals, networking, marketing, and customer interaction.
  • Identify Strategic growth opportunities, and maintain strong relationships with strategic customer and systems in the region.
  • Answer a wide range of questions concerning surgical applications, as well as clinical technique, related to technology platform.
  • Perform troubleshooting procedures to identify and resolve problems quickly and with confidence. 
  • Define targets and make recommendations to executive management

Position Requirements

  • Clinical experience; at least 2 years of experience working Capital Equipment 
  • Experience in selling complex solution in a surgical setting  
  • 5+ years of experience in medical device sales leadership
  • Strong proven track record of success, in complex sales cycles
  • Ability to go into surgery room and support surgeon during long and complex surgeries

Educational Requirements

  •  BS/BA 
  • MBA (Preferred)

Travel: 50%+

Years of experience:  7+

Degree: BS

Location: Boston, MA



Keywords for this title include: Sales Representative, Clinical Sales Representative, Account Manager, Territory Manager

Keywords for this position include: Capital Equipment, Navigation, Operating Room, C-suite Sales, Fluoroscopy, Robotics, President's Club, Circle of excellence, Master's Circle, Imaging, Therapeutic Imaging,  Diagnostic Imaging, Sales Management, Image Guided Surgery   

Prior experience from the following companies or similar is helpful: Medtronic, Aesculap, Anulex, GE, Philips, Toshiba, Hill Rom, Intuitive Surgical, Archus, Arthrocare, Atlas Spine, Avalign, Baxano, Benvenue, Biomet, Biomimedx, Centinel Spine, Choicespine, Codman, Depuy, Dfine, DiscMotion, DJO, Eminent Spine, Endius, Exactech, Flexuspine, Globus, Greatbatch, Integra LifeSciences, Integra Spine, Interventional Spine, Invuity, ISTO, Joimax, K2M, Kensey Nash, Kyphon, Lanx, LDR, Lifespine, Magellan Spine, Mako Surgical, Mazor Robotics, Medtronic Spinal, Medtronic Spine, Mekanika, Nexgen Spine, Nspine, Nuvasive, Orchid, Ortho Development, Orthofix, Orthovita, Osteomed, Osteotech, Pacific Spine, Paradigm Spine, Phygen Spine, Pioneer Surgical, Premia Spine, Raymedica, RTI Biologics, Seaspine, Simpirica, Simplicity Orthopedics, Sintea Biotech, Smith Nephew, Spartek Medical, Spinal Elements, Spinal Kinetics, SpinalMotion, Spine Align, Spine Smith, Spine Surgical, Spinecraft, SpineNet, Spineology, Spinesmith, Spinevision, Spinewave, Stryker, Stryker Spine, Surgical Orthomedics, Synthes Spine, Thekan Spine, Titan Spine, Trans1, Ulrich Medical, US Spine, Verticor, Vertiflex, Vertos Medical, Wenzel Spine, Wright Medical, X-Spine, Zimmer, Zyga Technology 


NOTE: This job description is not intended to be all-inclusive and may have been abbreviated or maximized for online or mobile viewing. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

 

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Tue, 01 May 2018 00:00:00 EDT 0