Job Description

• 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.

• Expertise in design control and quality systems (21 CFR 820.30, ISO 13485) with proven ability to plan, execute, and document design verification and validation for combination products.
• Hands-on capability in testing electromechanical systems, including data collection, statistical analysis, and performance evaluation.
• Proven ability to partner effectively with R&D, Quality, Regulatory, and Manufacturing teams.
• Nice to have: Minitab, Smartsheet, and supplier interaction experience

• 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, 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 Company’s 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.
• Ability to work on-site in Thousand Oaks full-time (3-5 days/wk).

• Lack of experience in hands-on testing in laboratory environments
• Unable to be consistently on-site in Thousand Oaks
• Low motivation/engagement at prospect of working with medical device and/or combination products
• Poor written and verbal communication
• Entry level or too experienced - hands on work is required and a strong eagerness to grow is required.