Senior Engineer (Electromechanical Combination Product)

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.