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Redbock - an NES Fircroft company

Redbock - an NES Fircroft company is hiring: Manufacturing Engineer in North Hav

Redbock - an NES Fircroft company, North Haven, CT, US, 06473

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MANFACTURING ENGINEER II (12-MONTH CONTRACT NO C2C, W2 ONLY)

Location: North Haven, CT


About the Role:

We are seeking a Manufacturing Engineer II for a consulting/contract assignment with a leading medical device company. In this role, you’ll work on-site supporting manufacturing operations, optimizing packaging and assembly lines, executing validations, and ensuring compliance with regulatory standards — all while providing your engineering expertise as a contractor.

Key Responsibilities:

  • Support day-to-day manufacturing operations at the client site, resolving line downtimes, scrap issues, and equipment challenges.
  • Conduct root cause investigations for nonconformances and implement corrective actions.
  • Execute equipment and process validation protocols (IQ/OQ/PQ).
  • Design and optimize manufacturing processes, equipment layouts, and production sequences.
  • Maintain technical documentation, SOPs, and batch records for regulatory compliance.
  • Collaborate with cross-functional teams, including Quality, R&D, and Supply Chain, while acting as the engineering consultant on-site.
  • Ensure compliance with FDA, ISO 13485, and cGMP standards.

Requirements:

  • 2–4 years of manufacturing engineering experience, preferably in the medical device industry.
  • Hands-on experience with packaging equipment (automated systems, bar sealers, form-fill-seal).
  • Strong troubleshooting and root cause analysis skills.
  • Experience executing IQ/OQ/PQ validations.
  • Excellent technical writing and documentation skills.
  • Strong cross-functional communication skills, with experience interfacing with client teams.