Manufacturing Engineer

Manufacturing Engineer – Contract (12+ months)

Location:

Mansfield, MA

Pay Range: $50–$60 per hour (variable based on experience, education, and location)

• Generate and execute validation plans, protocols (IQ/OQ/PQ), and completion reports, focusing on sterilization and microbiology of medical devices.
• Provide statistical analysis of data to support reports; generate and implement change controls and engineering notices (ECO).
• Develop statistically based sampling plans for in‑process and final testing, inspections, and validations.
• Troubleshoot equipment/processes that do not perform as intended during validation runs.
• Recommend process/quality improvements as part of validation runs.
• Evaluate, investigate, and document non‑conformance incidents and protocol deviations.
• Complete assigned Non‑Conformance and CAPA investigations and prepare investigation reports.
• Maintain effective cross‑functional relationships with plant and corporate Manufacturing, Engineering, Regulatory, and QA personnel.
• Work on project teams with internal departments, external vendors, and customers as required.
• Ensure compliance with regulatory and international agencies such as FDA, ISO, OSHA, EPA, and others.
• Participate in the compilation and review of technical documentation for domestic and international regulatory submissions.
• Participate in external audits (FDA, Notified Body, corporate, etc.) and perform related duties as necessary.

• Knowledge of FDA, OSHA, EPA, GMP, and ISO requirements.
• Knowledge in Organizational Excellence and Lean/Six Sigma.
• Ability to lead teams through complex projects and provide departmental technical leadership.
• Proven strategic thinking ability.
• Experience developing technical documentation such as Change Controls, Validation Plans, Protocols, Investigation Reports, SOPs, etc.

• B.S. in Engineering (Mechanical, Industrial, Electrical, Chemical, Biomedical, or related science) or Professional Engineer License;
  Lean/Six Sigma Green or Black Belt certification is a plus.
• Experience in validations of manufacturing equipment, processes, stability/aging.
• Minimum of 7+ years in the medical device and/or pharmaceutical manufacturing environment.

Equal Opportunity Employer/Veterans/Disabled

Benefit offerings for associates include medical, dental, vision, life insurance, short‑term disability, voluntary benefits, an EAP program, commuter benefits, and a 401(k) plan. Associates may be eligible for paid leave and holiday pay as applicable. Disclaimer:
These benefit offerings do not apply to client‑recruited jobs and direct hires.

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