Manufacturing Engineer I

Job Summary:

The Manufacturing Engineer I will be responsible for the selection, development, qualification, and scale-up of production processes and equipment across different manufacturing departments.  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.
  • 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 of engineering change orders from originator to final approval
  • Developing and updating preventative maintenance programs
  • Writing and executing process validation plans and reports, using sound, data/stats supported results
  • Selective Laser Sintering processes capability studies and efficiencies in accordance with medical device regulations.
  • Play a major role in the CNC process for the manufacturing of implants
  • Using Statistical tools for alternative material evaluations and validations projects
  • Support of material handling and control system
  • 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 bring proactive solutions and execution.
  • Other responsibilities as assigned.

Qualifications:

  • 0-3 years of experience in manufacturing process support and development in the medical device industry
  • Previous experience in orthopedics strongly preferred
  • Previous experience working with CNC machines is required
  • Medical Device/GMP experience preferred
  • Bachelor’s Degree in Engineering required, Master of Engineering Degree strongly preferred.

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.
  • Understanding of ISO 13485 and QSR regulations
  • Knowledge of statistical analysis (Green Belt preferred)
  • Experience working with SLS, SLA, other rapid prototype processes and CNC manufacturing processes
  • Knowledge of computer added design (solid works preferred)

ConforMIS is an Equal Opportunity Employer

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