Senior Manufacturing Engineer

Job detailsSenior Manufacturing Engineer - Medical Device / Design ControlsKelly 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, CASchedule: 100% Onsite | Monday-FridayEmployment Type: Contract-to-HirePay Rate: $65-$72/hr DOEKey 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 requirementsQualifications:• 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 skillsPreferred Background:• Medical device manufacturing• Combination products• Manufacturing scale-up and commercialization• Validation engineering• Automation and process improvement• FDA-regulated manufacturing environmentsCandidates with primarily quality assurance, regulatory-only, or production support backgrounds without direct manufacturing engineering ownership may not be a fit for this role.