Job Summary:

The Manufacturing Engineer I will be responsible for the selection, development, qualification, and scaleup 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.

Location: Wilmington, MA

Salary range: $75,000 - $80,000 + bonus

Essential Duties and Responsibilities:

• Develop and maintain strong, internal working relationships across restor3d.
• Understand the objectives, responsibilities, and mission of the Operations 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
• 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
• Playa major role in the CNC process for the manufacturing of implantsUsing
• 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 the needs of company’s selected fabrication processes.
• Participation in project teams as a key contributor bringing proactive solutions and execution.
• Other responsibilities as assigned.

Qualifications:

• 0 – 2 years of experience in manufacturing process support and development in the medical device industry.
• Previous experience in orthopedics strongly preferred
• Previous experience working with CNC machines is required
• Medical Device/GMP experience preferred
• Bachelor’s degree in engineering required

Skills, Abilities, Competencies Required:

• Excellent written and verbal communication skills.
• Able to work accurately in a fast-paced, ever-changing environment with a 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 (SolidWorks preferred).