Primary Skills: Electromechanical Systems (Advanced), Design Control (Advanced), Electromechanical Systems (Advanced), CAPA (Advanced), Test Protocol Development (Advanced),
Contract Type: W2 Contract
Duration: 12 Months
Location: Thousand Oaks CA (#LI- Onsite)
Pay Range: $30.00 - $40.00 Per Hour
#LP
Job Summary:We are seeking a contract Device Engineer to support design development and lifecycle management for commercialized drug delivery devices and electromechanical combination products. The ideal candidate brings hands-on expertise in design control, testing, and experience with medical devices or combination products in a highly regulated pharma environment.
Key Responsibilities:- Provide lifecycle management (LCM) support for combination products including post-market activities, design improvements, and cross-functional issue resolution
- Lead complaint investigations by performing failure analysis, identifying root causes, and developing corrective action plans
- Drive and manage CAPAs, deviations, and change controls ensuring compliance with regulatory and quality system requirements
- Collaborate with external suppliers and cross-functional teams (R&D, Quality, Regulatory, Manufacturing) for design reviews and continuous improvement
- Lead design verification activities including test protocol development, execution, and technical documentation
- Perform data analysis, traceability reviews, and on-site testing for electromechanical delivery systems
Must-Have Skills:- Bachelor's or Master's degree in Engineering (Mechanical, Biomedical, or Electrical) with 3-5 years in a highly regulated environment
- Strong preference for medical device, biopharma, and/or combination product experience with electromechanical systems
- Expertise in design control, design verification, CAPA processes, and regulatory compliance (21 CFR 820.30, ISO 13485)
- Proficiency in data analysis, statistical tools (Minitab preferred), and technical documentation
Industry Experience:Medical device industry
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