Job Description
Job Description
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.
Duties and responsibilities:
- Develop and maintain strong, internal working relationships across restor3d.
- 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 NCRs 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.
- 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 bringing proactive solutions and execution.
- Other responsibilities as assigned.
Required Education and Experience:
- 1-3 years of experience in manufacturing process support and development in the medical device industry.
- Bachelor’s Degree in Engineering required
Preferred Education and Experience:
- Previous experience in orthopedics strongly preferred
- Previous experience working with CNC machines preferred
- Medical Device/GMP experience preferred
Required Skills:
- Excellent written and verbal communication skills.
- Able to work accurately in medical device regulated 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 CNC manufacturing processes
- Knowledge of computer aided design (SolidWords preferred)
Physical Requirements:
- Working at a desk for prolonged periods of time.
- Working with CNC machines/equipment.