TITLE: Manufacturing Process Engineer

DEPARTMENT: Operations

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ConforMIS, Inc. is a privately held medical device company based in Burlington, Massachusetts. It was founded in 2004 to provide dramatic advancements in patient care by utilizing imaging technology to create personalized, patient-specific implants and instrumentation.

Job Summary:

This position is responsible for the selection, development, qualification, and scale-up of both internal manufacturing processes and suppliers. Process objectives are the high quality, high volume production of patient-tailored implants and associated instruments.

Essential Duties and Responsibilities:

· Verification and validation of processes and products using statistical analysis

· Assure compliance with the requirements set forth by US FDA QSR and ISO regulations on both internal processes and supplier products.

· Support and continuous improvement of current manufacturing processes

· Support R&D team by participating in design reviews, providing manufacturing input into design discussions, and review of design documentation.

· Work with suppliers to develop cost effective manufacturing processes that meet established company and industry guidelines.

· Find, develop, and qualify new suppliers

· Documentation of manufacturing processes and inspection criteria within the company’s documentation procedures.

· Evaluate and recommend capital equipment to best suit needs of company’s selected fabrication processes.

· Participate on project teams as liaison to operations and suppliers.

· Other duties as assigned

Qualifications:

· 5-10 years of experience in manufacturing process support and development for casting and/or machining operations.

· Medical Device/GMP experience preferred

· Bachelor’s Degree in Engineering.

Skills, Abilities, Competencies Required:

· Understanding of ISO 13485 and QSR regulations

· Knowledge of statistical analysis (Green Belt preferred)

· CNC machining and/or grinding processes preferred

· Investment casting experience preferred

· Injection molding experience preferred

· Strong verbal and written communication skills

· Ability to work in a team environment and execute job responsibilities with minimal direct supervision and have high attention to detail

ConforMIS is an Equal Opportunity Employer

CLICK HERE TO APPLY FOR THE POSITION

OR

GO TO WWW.MONSTER.COM AND SEARCH FOR “PROCESS ENGINEER” IN BURLINGTON, MA