Job Title: Senior Engineer – Medical Device Development

Location: Thousand Oaks, CA (80% On-Site)

Employment Type: Contract (Possible Extension)

*ONLY ABLE TO ACCEPT W2 CANDIDATES AT THIS TIME, NO C2C!*

Position Overview:

We are seeking a skilled Senior Engineer with a strong background in mechanical or electro-mechanical engineering to lead the development of innovative drug delivery devices. The ideal candidate will drive cross-functional technical teams, oversee root cause investigations, manage change controls, deviations, and CAPA, and contribute to the successful commercialization of mechanical and electro-mechanical medical devices. This role demands a results-oriented professional who thrives in a fast-paced environment and has a proven track record in the pharmaceutical or medical device industry.

Key Responsibilities:

• Lead technical teams in the design, development, and commercialization of drug delivery devices, including needle protection systems, fluid transfer devices, pen injectors, automatic injectors, and micro-infuser pumps.
• Collaborate cross-functionally with Marketing, Operations, and Development teams to ensure technical requirements and project milestones are achieved.
• Develop, execute, and review detailed engineering documentation, including architecture documents, design documents, specifications, protocols, and validation plans.
• Ensure compliance with design control processes, risk management, and regulatory requirements for Europe (EMEA/CE Mark) and US (FDA/PMA/510k) submissions.
• Create and execute project plans, schedules, and product requirements while ensuring integration of subsystems.
• Provide technical guidance and mentorship to junior engineers.
• Support root cause analysis, change control processes, and CAPA activities.
• Oversee material and test specification generation, process development, prototyping, design verification, and validation activities (IQ, OQ, PQ).
• Apply statistical tools, such as DOE and SPC, to optimize process development.

Day-to-Day Responsibilities:

• Lead projects independently with minimal supervision, ensuring timely completion.
• Collaborate with cross-functional teams to address technical challenges.
• Maintain a high level of documentation accuracy and compliance with regulatory requirements.

Qualifications:

• Strong background in engineering processes and procedures in the medical device/pharma industry.
• Proficiency in Good Documentation Practices (GDP).
• Hands-on experience in the design, development, and commercialization of electro-mechanical medical devices.
• Knowledge of drug/device combination product design and small-scale device assembly.
• Expertise in root cause investigations, risk assessment, and FMEA.
• Proficiency in statistical analysis tools (e.g., Minitab) and process optimization techniques.
• Strong problem-solving skills and ability to manage multiple projects in a deadline-driven environment.
• Experience with protocol/report writing and test development.

Education:

• Doctorate degree
• OR Master’s degree with 3+ years of relevant experience
• OR Bachelor’s degree with 5+ years of relevant experience
• OR Associate’s degree with 10+ years of relevant experience
• OR High school diploma/GED with 12+ years of relevant experience

Top 3 Must-Have Skills:

1. Previous experience in the medical device or pharmaceutical industry.
2. Strong project management capabilities.
3. Proficiency in Good Documentation Practices (GDP).