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.
- 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.
- 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
Arshad is a seasoned recruiter in the healthcare space with over 15 years of experience in promoting career growth for healthcare professionals. He has played a critical role in the launch of several startup companies. He is known for versatility and leadership; expert in overseeing high-level priorities and a broad range of responsibilities.