Senior Manufacturing Engineer – Medical Device / Design Controls

Kelly Engineering is seeking a Senior Manufacturing Engineer to support a rapidly growing medical device and regulated manufacturing environment in Petaluma, CA.

This is a highly hands-on engineering role focused on manufacturing process ownership, design controls, validation, and commercialization support in a fast-paced GMP/ISO 13485 environment.

The team is looking for a true plug-and-play senior engineer who can operate independently and immediately contribute to manufacturing operations, process improvements, validation execution, and cross-functional engineering initiatives.

Location: Petaluma, CA
Schedule: 100% Onsite | Monday–Friday
Employment Type: Contract-to-Hire
Pay Rate: $65–$72/hr DOE

Key Responsibilities:
• Lead manufacturing engineering activities in a regulated medical device manufacturing environment
• Support design controls, manufacturing transfer, process validation, and commercialization activities
• Independently drive process improvements, technical investigations, CAPAs, deviations, and root cause analysis
• Partner cross-functionally with Quality, Manufacturing, Validation, and R&D teams to support production readiness and compliant manufacturing processes
• Author and review engineering documentation including SOPs, work instructions, validation protocols, and technical reports
• Support equipment qualification and manufacturing process validation activities including IQ/OQ/PQ execution
• Participate in DFMEA/PFMEA, risk assessments, change controls, and engineering reviews
• Troubleshoot manufacturing and process issues in real time and drive corrective actions to resolution
• Support supplier qualification, manufacturing scale-up, and process optimization efforts
• Ensure compliance with GMP, ISO 13485, FDA, and internal quality system requirements

Qualifications:
• 8–10+ years of Manufacturing Engineering experience in regulated medical device, biotech, pharmaceutical, or combination product environments
• Strong background in medical device design controls and product lifecycle management
• Experience supporting manufacturing transfer, process development, and commercialization activities
• Hands-on experience with validation activities including IQ/OQ/PQ and process validation
• Strong knowledge of GMP, FDA regulations, ISO 13485, CAPA, change control, and risk management methodologies
• Experience working independently in fast-moving startup or high-growth manufacturing environments
• Proven ability to troubleshoot manufacturing issues and drive technical solutions with minimal oversight
• Excellent communication and technical documentation skills

Preferred Background:
• Medical device manufacturing
• Combination products
• Manufacturing scale-up and commercialization
• Validation engineering
• Automation and process improvement
• FDA-regulated manufacturing environments

Candidates with primarily quality assurance, regulatory-only, or production support backgrounds without direct manufacturing engineering ownership may not be a fit for this role.

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