Senior Manufacturing Engineer

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.

Petaluma, CA

100% Onsite | Monday–Friday

Contract‑to‑Hire

$65–$72/hr DOE

• 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

• 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

• 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.