The Manufacturing Engineer II will be responsible for selection, development, qualification, and scale-up of production processes and equipment in the Selective Laser Sintering department. Process objectives are the high quality, high volume production of patient-tailored implants and associated instruments.

Essential Duties and Responsibilities:

• Develop and maintain strong, internal working relationships across ConforMIS.

• Understand the objectives, responsibilities, and mission of the Operations department and works towards those goals.

• Prioritize and plan work activities; adapt for changing conditions.

• Performs the design and validation of packaging for all products shipped to ConforMIS’ customers, including validation protocol development, execution and report generation.

• Responsible for the design of packaging configuration for sterile and non-sterile packaged products.

• Generate systems required to implement processes and packaging.

• Ensures the quality of packaging based on ISO 11607.

• Assess potential damage from handling, drops, vibration during transportation and compression from storage while keeping sterility a top concern.

• Oversight and maintenance of electronic production records processes and systems.

• Initiation, execution, and documentation of IQ, OQ, & PQ activities Optimization of manufacturing processes (5S) for Lean Manufacturing.

• Development of formal training programs for the production personnel.

• Day-to-day production support activities such as NCMRs and CAPAs.

• Processing and engineering change orders from originator to final approval.

• Developing and updating preventative maintenance programs.

• Writing and executing validation plans and reports, using sound, data/stats supported reports.

• Clean room processes and efficiencies in accordance with medical device regulations.

• Conduct time studies and process flow mapping.

• Assure compliance with the requirements set forth by US FDA QSR and ISO regulations.

• 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.

• Participation on project teams as a key contributor brings proactive solutions and execution.

• Other responsibilities as assigned.

Qualifications:

• 3+ years of experience in manufacturing process support and development in the medical device industry.

• Medical Device/GMP experience preferred.

• Bachelor’s Degree in Engineering.

Skills, Abilities, Competencies Required:

• Excellent written and verbal communication skills.

• Able to work accurately in a fast-paced, hectic, ever-changing environment with strong attention to detail.

• Demonstrated ability to monitor own work to ensure quality, accuracy and thoroughness.

• Strong organizational, analytical and time-management skills.

• Able to self-motivate and work both independently and as part of a team.

• Knowledge of statistical analysis (Green Belt preferred).

• Knowledge and experience with Controlled Environment Rooms.

• Understanding of ISO 13485 and QSR regulations.

• Strong knowledge and experience with ERP systems.

• Knowledge of CAPA, Quality Planning, Process Validation and Packaging standards is necessary.

• Strong knowledge and experience with electronic record systems.

• Strong knowledge and experience with medical device labeling.

ConforMIS is an Equal Opportunity Employer

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