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Senior Engineer (Electromechanical Combination Product)

Thousand Oaks, CA 91320

Posted: 12/04/2025 Employment Type: Contract Job Category: Engineering Job Number: 623741 Is job remote?: No Country: United States

Job Description

Target PR Range: 37-47/hr
*Depending on experience

Seeking a contract electromechanical combination product Sr. Engineer. The Sr. Engineer will lead and support design development and lifecycle management-related activities for commercialized drug delivery devices and devices under development.

Responsibilities:
• Provide design verification support for combination products, ensuring compliance with Quality System Requirements, Design Control (21 CFR 820.30), and ISO 13485.
• Lead and execute on-site testing and verification activities for electromechanical delivery systems and related platforms.
• Develop, review, and execute test protocols, reports, and technical documentation in accordance with design control and regulatory expectations.
• Perform data verification, analysis, and traceability reviews to ensure product performance meets user needs and design inputs.
• Manage materials and maintain traceability of material inventory at Thousand Oaks to support various design control activities. Additionally, support supply of the materials as required to internal and external sites.
• Partner cross-functionally with R&D, Human Factors, Quality, Regulatory, and Manufacturing teams to drive design robustness, risk mitigation, and design transfer readiness.
• Support control plans, requirements management, and risk management activities (DFMEA, PFMEA) as part of design verification strategy.
• Contribute to continuous improvement of test methods, design verification processes, and documentation practices in line with device development framework.
• Manage change assessments driven by internal and external changes during the life cycle of the combination product
• Participate in and support cross-functional design reviews for combination product development.

Preferred Qualifications:
• Master’s or Bachelor’s Degree in Engineering Discipline (Mechanical, Biomedical, Electrical) with 5-7 years (or 3-5 years with Masters) of professional experience in highly regulated environment (strong preference for medical device, biopharma and/or combination product experience).
• Experience with electromechanical systems, injection devices, or delivery platforms preferred.
• Demonstrated expertise in design verification testing, data analysis, and protocol/report generation under design control.
• Strong understanding of materials coordination, supplier interaction, and lab testing logistics.
• Proven ability to work in cross-functional project teams, communicate technical results clearly, and lead execution to meet program milestones.
• Working proficiency in statistical analysis software (Minitab)
• Smartsheets proficiency is a plus.
• Ability to work independently and dynamically across functional teams
• Excellent written and verbal communication skills
• Ability to work on-site in Thousand Oaks full-time (3-5 days/wk).
• Must be capable of working on multiple projects in a deadline driven environment.
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About Thousand Oaks, CA

Ready to take your career to the next level in the vibrant city of Thousand Oaks, California? Nestled in the heart of Ventura County, this bustling city offers a perfect blend of suburban charm and urban amenities. With a strong job market, top-notch schools, and breathtaking views of the Santa Monica Mountains, Thousand Oaks is an ideal location for professionals seeking growth and fulfillment. Explore job opportunities near iconic sites like the Gardens of the World, catch a show at the Fred Kavli Theatre, or indulge in the local culinary scene featuring dishes from around the world. Join this dynamic community and unlock your potential in Thousand Oaks! Start your job search now to find your perfect fit in this captivating city.