Manufacturing Engineer

Akkodis; Mansfield (MA); On-site; USD 68,880 - 82,656; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) plan

EAP program

Job summary

A leading engineering services provider is seeking a Manufacturing Engineer for a contract role based in Massachusetts. The successful candidate will generate and execute validation plans for medical devices, ensuring compliance with FDA and international regulations. Candidates should have a B.S. in Engineering and 7+ years in the medical device or pharmaceutical industry, with strong analytical skills and experience in technical documentation. This position offers competitive pay of $50–$60 per hour based on experience.

Qualifications

• 7+ years in medical device or pharmaceutical manufacturing.
• Proven strategic thinking ability.
• Experience in validations of manufacturing equipment and processes.

Responsibilities

• Generate and execute validation plans for medical devices.
• Provide statistical analysis of data for reports.
• Ensure compliance with FDA and international regulations.
• Participate in external audits and technical documentation review.

Skills

Knowledge of FDA regulations

Knowledge of Lean/Six Sigma

Statistical analysis skills

Ability to lead teams

Experience with technical documentation

Education

B.S. in Engineering or Professional Engineer License

Job description

Manufacturing Engineer – Contract (12+ months)

Location: Mansfield, MA

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

Position Responsibilities

• 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.

Qualifications

• 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.

Education and Experience

• 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.

If you are interested in this Manufacturing Engineer role, please click APPLY NOW. For other opportunities, visit www.akkodis.com. Contact Sunny Kumar at [e-mail] for questions.