Manufacturing Engineer I
The Manufacturing Engineer I will be responsible for the 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 work 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.
- Using Statistical tools for alternative materiel 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.
- BS in Engineering required, Master of Engineering Degree strongly preferred.
- 0-3 years of experience in manufacturing process support and development in the medical device industry.
- Previous experience in orthopedics strongly preferred.
- Medical Device/GMP experience 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, and other rapid prototype processes.
- Knowledge of computer aided design (sold works preferred).
ConforMIS is an Equal Opportunity Employer