Manufacturing Engineer II

Job Summary:

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, and 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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