Manufacturing Engineer – Medical Device

Hello,

I hope you're doing well.

My name is Jahera, and I’m reaching out from Intellectt Inc. regarding a Manufacturing Engineer contract opportunity in Camarillo, CA (Onsite) with one of our leading clients.

Job Title: Manufacturing Engineer – Medical Device

Job Description:

• Support New Product Introduction (NPI), manufacturing process development, optimization, and scale-up within medical device/life sciences environments.
• Execute equipment validation activities including IQ/OQ/PQ, process validation, and Test Method Validation (TMV).
• Apply DOE, SPC, Minitab/JMP, Gage R&R, and statistical analysis to improve yield, quality, and process capability.
• Develop and maintain URS, validation protocols/reports, SOPs, MPIs, Work Instructions, BOMs, and engineering documentation.
• Support pFMEA, root cause analysis, CAPA, continuous improvement, and Lean/Six Sigma initiatives.
• Design tooling and fixtures using SolidWorks and apply GD&T, DFM, and manufacturing engineering principles.
• Partner with R&D, Quality, Supply Chain, and suppliers on material specifications, process changes, and product transfers.
• Work within GMP, FDA, and ISO 13485 regulated medical device manufacturing environments.
• Support sterilization validation, injection molding, packaging, equipment qualification, and manufacturing process improvements.
• Manage process changes and engineering documentation through ECO/DCO and QMS/PLM systems.

If you’re currently open to new opportunities, I’d be happy to connect for a quick discussion and share more details. You can reply to this email or share your updated resume at Jahera@intellectt.com, or feel free to call me at +1 (732) 276-1791.