Manufacturing Engineer II

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.
   

Qualifications:

• 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.

Skills, Abilities, Competencies 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).
• Knowledge of C++, C#, and/or python programming language is a plus.