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
