ApTask Global Workforce (AGW) is seeking a Engineer Senior with a Biotechnology company. This is a 12+ month contract opportunity with our client located in Thousand Oaks, CA. This is Hybrid position. Summary: This role will participate in design development and lifecycle management-related activities for commercialized drug delivery devices and devices under development. The ideal candidate will have experience with combination products, electromechanical systems, or medical devices, with a background in pharmaceuticals and hands-on expertise in design control and testing.
Responsibilities: - Provide ongoing lifecycle management (LCM) support for electromechanical combination products, including post-market activities, design improvements, and cross-functional issue resolution
- Lead complaint investigations by performing detailed failure analysis, identifying root causes, and developing data-driven action plans
- Drive and manage quality system processes including CAPAs, deviations, and change controls
- Collaborate closely with external suppliers to support LCM activities, including issue resolution, component updates, and root cause analysis
- 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 (21 CFR 820.30) and ISO 13485
- Lead and execute on-site testing and verification activities for electromechanical delivery systems
- Develop, review, and execute test protocols, reports, and technical documentation
- 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
Requirements: - Master's or Bachelor's Degree in an Engineering Discipline (Mechanical, Biomedical, Electrical)
- 3-5 years of professional experience in a highly regulated environment (or 2 years with a Master's degree)
- Experience with electromechanical systems, injection devices, medical devices or delivery platforms
- Lifecycle Management Experience with electromechanical platforms
- Experience in root cause analysis and technical problem solving
- Demonstrated expertise in 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 and communicate technical results clearly
- Working proficiency in statistical analysis software (Minitab)
- Excellent written and verbal communication skills
Desired skills: - Early device development experience
- Smartsheets proficiency
Pay range: Up to $48.82 per Hour
Only candidates available and ready to work directly as ApTask Global Workforce (AGW) employees will be considered for this position.
If you have the described qualifications and are interested in this exciting opportunity, please apply! ApTask Global Workforce (AGW) ApTask Global Workforce (AGW) is a certified Minority and Veteran workforce solutions company. AGW delivers operational, clinical, lab and professional talent with a strong focus on healthcare and life sciences. The company supports clients with reliable staffing, program expertise and a commitment to quality, speed and consistent delivery.
Benefits of working with ApTask Global Workforce include: - Medical
- Dental
- Vision
- Sick Pay (for applicable states/municipalities)
Our team stays close to the process and is here to guide you every step of the way. To learn more, please visit our website
ApTask Global Workforce is an Equal Opportunity Employer. Candidates will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability or status as a protected veteran.
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