Medical Device Senior Advanced Manufacturing Engineer

Company : Nexus Staff

Country: United States

Location : Cambridge, Massachusetts

Post: Fri, 24 Mar 2023 06:24:43 GMT

Expires: Fri, 21 Apr 2023 23:59:59 GMT

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—————————— Job Description ——————————

Developing manufacturing processes to support medical device product development projects, especially the project with catheters and other disposable devices

Collecting information to prospectively evaluate quality, cost, delivery, and management of contract manufacturing partners

Supervising and collaborating with contract manufacturers in the selection and development of manufacturing processes and sites

Ensure DFM, Six Sigma, and LEAN considerations are incorporated into product and process designs, including design and process 3P

Review engineering product specifications, CAD data/drawings, as part of the design review process to ensure they meet industry and manufacturing standards and practices

Manage pilot production builds, planning, tracking, and execution

Drive the development and execution of complex experiments and tests (including writing and executing protocols) on new or existing product lines to qualify and validate manufacturing processes, analyze results, make recommendations, and develop reports

Responsible for Characterization and Validation activities, including CTQ flow-down and identification of critical control points within manufacturing

Act as the liaison between Contract Manufacturing Organization (CMO), and Canon to co-ordinate manufacturing activities as directed by Management

Deploy manufacturing risk assessment and mitigations, including hands-on and resourceful action plans

Responsible for part/drawing release, and accuracy of the Bill of Materials (BOM)

Developing and maintaining manufacturing work instructions, equipment instructions, and other documents that require quality management system controls

Coordinating technical communications between company and contract manufacturers, including design transfer

Developing processes to monitor manufacturing performance on an ongoing basis to ensure quality, productivity, and delivery

Providing technical expertise in conducting PFMEA and developing process validations

Coordinating builds for prototypes, validations, and pilot runs

Sharing expertise in Lean Six Sigma process excellence principles

Collaborating with cross-functional product development teams including project managers, optical engineers, mechanical engineering, electrical engineers, software engineers, quality engineers, regulatory specialists, clinical specialists, marketers, buyers, and others

Ability to travel up to 20% domestically as needed

Bachelor’s degree in an engineering discipline required

5 years experience in medical device manufacturing engineering

3 years experience in new product development, manufacturing engineering, including time working with contract manufacturers/vendors working with electronics testing and/or catheter manufacturing is strongly preferred

Proficient in the use of CAD, preferably Solidworks

Proven track record in design transfers to Operations and process, equipment validation experience

Understand injection molding, polymers and commonly used materials in the medical device space, such as Nitinol, with working knowledge of metal processing

Technical expertise in manufacturing engineering: design for manufacturability, design and process excellence methodologies including Six Sigma, LEAN experience GMPcGMP, EH&S guidelines, supplier development engineering and process validation

Strong proficiency with Microsoft Office Suite and Minitab Statistical Analysis software or equivalent

Lean and/or Six Sigma certifications preferred

 
Results Expected:

Development and maintenance of project task list for DFM Activities

Creation and maintenance up-to-date BOM’s, Work Instructions, and Travelers

Creation and maintenance pFMEA