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
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.