<![CDATA[Legacy MedSearch: jobboards]]> http://JOBS.LEGACYMEDSEARCH.COM/ en-us <![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[Manufacturing Manager]]> Position Summary:

Our client. is currently looking for a highly motivated Manufacturing Manager with a strong engineering or operations management background 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:

  • Supervise team of Production personnel.This includes hiring, developing, scheduling and directing employees, communicating expectations, managing performance, and addressing questions or concerns.
  • Lead efforts to ensure all production related activities are executed in a timely manner to satisfy Company’s Production schedule and quality standards.
  • Monitor the accuracy, completeness, and timeliness of manufacturing processes.
  • Identify opportunities to streamline Production process and remove inefficiencies. Ensure Production areas are maintained in an orderly manner, production documentation is accurate and up to date and that production and test equipment are properly maintained.
  • Work with Supply Chain, Quality and Production personnel to resolve component issues and expedite materials through the procurement, inspection and production processes.
  • Work with Technical team to identify and resolve technical and quality related issues identified in production.
  • Work with Engineering team to indroduce new products into production including reviewing and approving Manufacturing Instructions, Process Validations.
  • Ensure Production team members are appropriately trained for assembly and test activities, as well as on company Standard Operating Procedures, as required.
  • Support Facility related activities as required.
  • Perform other tasks and duties as required.

 

Position Requirements:

  • BS Engineering or Operations Management plus a minimum of 5 years manufacturing experience working in FDA/ISO regulated medical device/ medical equipment industry, or equivalent combination of education and experience.
  • Must be detail oriented with strong priorization and organizational skills.
  • Strong leadership and 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.
  • Ability to identify, prioritize and resolve issues as they arise with minimal supervision.  

 

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Tue, 26 Jun 2018 00:00:00 EDT 0
<![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 - Knee]]> Position Summary - Product Development Engineer - Knee

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 (Heavy preference for experience in knee development)
  • Candidate must be experienced with full lifecycle manufacturing processes
     
  • 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

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Tue, 22 May 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[Field Service Engineer]]> Position Overview: 

The Field Service Engineer for this rapidly growing, international medical device company will support an innovative therapeutic technology used in several different clinical settings.  The FSE will work with a complex piece of capital electromechanical equipment running upwards of $1 MM.

As our client’s site count increases dramatically in the U.S., this role will be mostly install based vs Preventative Maintenance or Troubleshooting.

Due to the confidentiality of this role, more details will be discussed in conversation with qualified candidates.


 

Primary Responsibilities

  • Capital Equipment Installation / Repair / Preventative Maintenance.
  • Software troubleshooting, installation, updates, etc.
  • Direct management of parts and inventory.
  • Identification of product and service improvement opportunities.
  • Ensuring customer with timely resolution of problems associated with equipment and/or software.
  • High amounts of travel (60-80%)

Position Requirements

  • 8+ years field service experience on Medical Device Capital Equipment
  • Experience troubleshooting highly complex, electromechanical capital equipment, with a software component at a systems level
  • Proven track record of working independently meeting complex objectives under strict timelines
  • Hands on experience, servicing Multi-Disciplinary Medical Imaging systems
  • Must be ready to travel at short notice
  • Must have a valid driving license, a clean driving record and be able to be insurable under the company’s policies

Educational Requirements

  • Bachelor’s Degree, in Electrical/Electronics from an accredited university or college
  • Military Training Certifications applicable as well
     

Location:
  • West Coast
Recruiter:
  • Arshad Alam
Recruiter Email:
Recruiter Phone:
  • 407-591-3030

Keywords for this Title Include: Field Service, Service Engineer, FSE, Field Service Engineer, Regional Service Engineer, Technical Support Engineer

Keywords for this Position Include : C-Arm, MRI, CT, PET CT, X-Ray, Ultrasound, Computer Tomography, Fluoroscopy, Medical Device, Diagnostic Imaging, Biomedical, Electromechanical, Mechanical, Capital Equipment

Prior experience with the following or similar companies is helpful:  Siemens, Phillips, Integra Life Sciences, GE Healthcare, Neurologica, Analogic, Phillips, Biomet, Accuray, Varian Medical, Veran Medical, Toshiba, Hansen Medical, Intuitive Surgical, Volcano, Philips Medical

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Fri, 11 May 2018 00:00:00 EDT 0