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
با جستجو در پایگاه داده‌های ویپاب، فرصتهای شغلی مورد نظر خود را بیابید و یا یک فرصت شغلی را معرفی نمایید.
 

This is an animated dialog which is useful for displaying information. The dialog window can be moved, resized and closed with the 'x' icon.

These items will be permanently deleted and cannot be recovered. Are you sure?