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.