Title: Senior Engineer
Location: Thousand Oaks, CA
Duration: 12 months
Description:
3-5 days onsite depending on business needs - Standard hours
Ideal candidate: Seeking candidates with experience in combination products, electromechanical systems, or medical devices, a background in pharma, and hands-on expertise in design control and testing.
- Provide ongoing lifecycle management (LCM) support for electromechanical combination products, including post-market activities, design improvements, and cross-functional issue resolution to ensure product reliability and compliance.
- Lead complaint investigations by performing detailed failure analysis, identifying root causes, and developing data-driven action plans in collaboration with quality, manufacturing, and regulatory teams.
- Drive and manage quality system processes including CAPAs, deviations, and change controls, ensuring timely closure, robust documentation, and alignment with regulatory and internal requirements.
- Collaborate closely with external suppliers to support LCM activities, including issue resolution, component updates, root cause analysis, CAPAs and continuous improvement initiatives to maintain supply continuity and product performance.
- 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.
- 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.
- Partner cross-functionally with R&D, Human Factors, Quality, Regulatory, and Manufacturing teams to drive design robustness, risk mitigation, and design transfer readiness.
This position pays $48-$52/hr on W2