Manufacturing Engineer II
Job in
Wilmington, Middlesex County, Massachusetts, 01887, USA
Listed on 2026-06-02
Listing for:
restor3d
Full Time
position Listed on 2026-06-02
Job specializations:
-
Engineering
Quality Engineering, Manufacturing Engineer, Process Engineer
Job Description & How to Apply Below
TITLE:
Manufacturing Engineer II
DEPARTMENT: MFG Engineering
REPORTS TO:
Principal Process Engineer
STATUS:
Exempt
LOCATION:
Wilmington, MA
Job Summary:
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.
Essential Duties and 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.
- 3-5 years of experience in manufacturing process support and development in the medical device industry.
- Previous experience in orthopedics strongly preferred.
- Medical Device/GMP experience required.
- Bachelor's Degree in Engineering required.
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 clean rooms, 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 (Solid Works preferred).
- Knowledge of C++, C#, and/or python programming language is a plus.
$80,000.00 Annually to $85,000.00 Annually
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