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.
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
Why Kelly ® Engineering?
Your engineering skills are in demand, but how do you find the right fit? Easy. At Kelly Engineering, our team creates expert talent solutions to solve the world's most critical challenges. We connect you with leading organizations where you can collaborate on innovative projects, work with cutting-edge technologies and accelerate your growth. Whether you prefer the variety and flexibility of short-term projects or are looking for a long-term opportunity, we're here to guide you to the next step in your engineering career.
About Kelly
Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life-just ask the 300,000 people we employ each year.
Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
Kelly may use AI-powered tools during the recruitment and hiring process. For full details, including how Kelly uses AI, your rights, and how to request a reasonable accommodation, visit the Recruitment Artificial Intelligence Notice (https://www.kellyservices.com/hubfs/myKelly/Resources/Employment_Policies/Recruitment-Artificial-Intelligence-Notice.pdf?hsLang=en) .
Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
