Unknown Company

Lead Design Control Engineer

petaluma, ca • Posted 2 days ago
Onsite Contract General

Lead Design Control EngineerLocation: Petaluma, CAEmployment Type: Contract-to-HireSchedule: Full-time, standard business hoursPay Rate: $70 per hourA 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 DoLead 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 Bring5+ 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.

Back to Job Search