Senior Manufacturing Engineer

** Sr Manufacturing Engineer | Petaluma, CA*
* **$70-$85/hr DOE based on relevant experience and technical fit | Contract-to-Hire | 100% Onsite*
* Kelly Engineering is seeking a Senior Manufacturing Engineer to support a rapidly growing medical device organization focused on product commercialization, manufacturing scale-up, and regulated product development.

This is a high-impact role supporting the transfer of products from R&D into manufacturing within a fast-paced, startup-style environment. The team is looking for someone who can operate independently, solve problems quickly, and drive manufacturing and validation activities with minimal hand holding.

If you enjoy building processes, improving manufacturing systems, and helping bring products from development into production, this is the type of role where you can make a major impact immediately.

** What You'll Be Doing*
* - Lead manufacturing transfer and design transfer activities from R&D into production

- Support new product introduction (NPI), commercialization, and manufacturing scale-up initiatives

- Develop and improve manufacturing processes, work instructions, and production documentation

- Write and execute validation protocols including IQ/OQ/PQ, equipment validation, and process validation

- Drive deviation investigations, CAPA activities, risk assessments, and root cause analysis

- Partner cross-functionally with R&D, Quality, Validation, Supply Chain, and Manufacturing teams

- Support equipment qualifications, process improvements, and manufacturing optimization projects

- Ensure compliance with FDA regulations, GMP requirements, and ISO 13485 standards

** What They're Looking For*
* - 8-10+ years of Manufacturing Engineering experience within medical device, biotech, pharma, or other highly regulated industries

- Strong experience supporting products from R&D through manufacturing and commercialization

- Hands-on Design Control and Design Transfer experience

- Strong validation background including IQ/OQ/PQ, process validation, equipment validation, deviations, and CAPAs

- Working knowledge of FDA regulations, GMP, and ISO 13485 requirements

- Ability to work independently in a fast-paced environment with changing priorities

- Strong technical writing, documentation, and communication skills

- Proven ability to solve problems and move projects forward with minimal oversight

** Preferred Experience*
* - Combination product or drug product manufacturing experience

- Manufacturing scale-up and commercialization experience

- Experience with DHF/DMR documentation, risk management, or FDA submissions

- Experience supporting startup or rapidly growing manufacturing environments

** Why This Opportunity Stands Out*
* - High-visibility role with strong cross-functional exposure

- Opportunity to help shape manufacturing processes during rapid company growth

- Collaborative and highly technical team environment

- Long-term growth potential within the organization

- Contract-to-hire opportunity with strong conversion potential for the right person

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.  ()  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…