Lead Design Control Engineer

Job Description

Job Description

Lead Design Control Engineer

Location: Petaluma, CA
Employment Type: Contract-to-Hire
Schedule: Full-time, standard business hours
Pay Rate: $70 per hour

A growing medical device and pharmaceutical organization is seeking a Lead Design Control Engineer to support upcoming product, process, equipment, and facility changes. This person will lead design control activities, develop project roadmaps, and help prepare manufacturing operations for the company’s next phase of growth.

What You’ll Do

• Lead design control activities for product, process, facility, and equipment changes.
• Assess existing systems and develop a roadmap for upcoming design and manufacturing work.
• Coordinate upgrades involving an RO system, gas systems, manufacturing tanks, cleanroom areas, and a new bottling line.
• Ensure design changes are properly planned, documented, reviewed, verified, validated, and implemented.
• Partner with Engineering, Manufacturing, R&D, Quality, and Regulatory.
• Support continued cGMP compliance.
• Define project requirements, responsibilities, timelines, and resources.
• Provide technical guidance to engineers supporting equipment and R&D activities.

What You’ll Bring

• 5+ years of engineering and design control experience; 7+ years is preferred.
• Direct medical device design control experience.
• Experience leading multiple design changes through implementation.
• Strong knowledge of cGMP and regulated manufacturing environments.
• Ability to independently lead design control activities and manage competing priorities.
• Experience with manufacturing equipment, utilities, cleanrooms, process systems, or production-line upgrades.
• Strong cross-functional communication, organization, and decision-making skills.
• Pharmaceutical, drug-development, or IND-related experience is highly preferred.

This position may convert to a regular full-time role based on performance, business needs, and long-term fit. Conversion is not guaranteed.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Please note: The following benefits reflect Kelly's general offerings. Eligibility may vary by assignment, location, and job type. 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 for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Engineering?

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About Kelly

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