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.

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.