Manufacturing Engineer III

Peak Performers has partnered with a global medical technology company to assist in their search for a Manufacturing Engineer III. In this contract position, you will you will serve as a key technical contributor within cross-functional project teams, acting as the voice of operations while supporting design transfer, validation, and risk mitigation activities for medical device manufacturing processes with a strong focus on endotoxin, sterilization, and microbiology requirements.

Major Duties

• Lead design transfer activities for manufacturing processes, with specific responsibility for endotoxin, sterilization, and microbiological requirements.
• Generate and execute validation master plans, validation plans, protocols (IQ/OQ/PQ), and final reports for manufacturing processes and equipment.
• Provide statistical analysis of validation data to support conclusions and regulatory compliance.
• Actively participate in project management activities, working closely with cross-functional project teams.
• Serve as the voice of operations, collaborating with Product Design, Facilities, Microbiology Services, Quality, and Manufacturing.
• Develop and implement change controls, engineering change orders (ECOs), and engineering notices.
• Identify, assess, and mitigate risk through Risk Mitigation activities, Non-Conformance investigations, and CAPA execution.
• Troubleshoot equipment and processes that do not perform as intended during validation or routine manufacturing.
• Evaluate, investigate, and document non-conformances, protocol deviations, and manufacturing incidents.
• Prepare comprehensive investigation reports and support closure of assigned CAPAs.
• Develop and maintain strong cross-functional working relationships with Manufacturing, Engineering, Regulatory, Quality Assurance, and external vendors.
• Ensure all processes and activities comply with FDA, ISO, OSHA, EPA, and other applicable regulatory and international standards
• Participate in the preparation and review of technical documentation for domestic and international regulatory submissions.
• Support and participate in external audits including FDA, Notified Body (BSI), and internal corporate audits.
  
  

What are we looking for?

• Bachelor’s degree in Engineering (Mechanical, Industrial, Electrical, Chemical, Biomedical) or a related science discipline required.
• Professional Engineer (PE) license preferred but not required.
• Minimum of 7 years of experience in a medical device and/or pharmaceutical manufacturing environment.
• Hands-on experience with process, equipment, sterilization, microbiology, stability, or aging validations required.
• Strong working knowledge of FDA, OSHA, EPA, GMPs, and ISO requirements.
• Experience supporting medical device manufacturing; life sciences experience may also be considered.
• Proven ability to lead and contribute in cross-functional, project-based environments.
• Strong project management skills with the ability to manage competing priorities.
• Demonstrated experience in Risk Management, CAPA, and non-conformance investigations.
• Ability to develop high-quality technical documentation including Validation Plans, Validation Protocols, Change Controls, SOPs, and investigation reports.
• Excellent communication skills with a track record of effective collaboration across functions.
• Strategic thinker with a continuous improvement mindset.
• Knowledge of Lean Manufacturing and Six Sigma methodologies; Green or Black Belt certification is a plus.
• Self-starter with strong teamwork orientation.
  
  

About This Position

• Rate: $62.79/hour
• Contract Length: 6 months with opportunity to extend
• Onsite in Mansfield, MA
  
  

The Peak Performers difference

• Excellent medical health, dental & vision insurance at 60 days
• Our employees may choose to participate in a 403(b) retirement plan
• Qualified applicants with chronic medical conditions and/or disabilities receive priority placement
• We pay weekly through direct deposit
• In business since 1994 and thousands of job placements
  
  

All employment offers are contingent on the successful completion of a pre-employment criminal background check, in compliance with all applicable federal and state laws.

Applicants for employment with Peak Performers must possess work authorization that does not require sponsorship for a visa now or in the future.

Peak Performers is an equal opportunity employer and will consider all applicants without regard to race, marital status, sex, age, color, religion, national origin, veteran status, disability or any other characteristic protected by law. Peak Performers does not accept unsolicited resumes from headhunters, recruitment agencies or fee-based recruitment services.

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