Manufacturing Engineer II

restor3d•Wilmington, MA

3d•Onsite

About The Position

The Manufacturing Engineer II 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.

Requirements

3-5 years of experience in manufacturing process support and development in the medical device industry.
Medical Device/GMP experience required.
Bachelor’s Degree in Engineering required.
Excellent written and verbal communication skills.
Understanding of ISO 13485 and QSR regulations.
Able to work accurately in medical device regulated environment with strong attention to detail.
Experience with ISO Class 7 cleanrooms, or equivalent.
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.
Knowledge of statistical analysis.
Knowledge of computer added design (SolidWorks preferred).

Nice To Haves

Previous experience in orthopedics strongly preferred.
Knowledge of C++, C#, and/or python programming language is a plus.

Responsibilities

Develop and maintain strong internal working relationships across restor3d.
Understand the objectives, responsibilities, and mission of the Engineering 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.
Processing of engineering change orders from originator to final approval.
Writing and executing process validation plans and reports using sound, data/stats supported results.
Troubleshoot process failures and perform root cause analysis.
Using Statistical tools for alternative material evaluations and validations projects.
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.