Sr. Engineer, Device Development

Job Summary

A fast-growing biotechnology client is seeking a high-caliber Senior Engineer II, Device Development to provide immediate technical leadership in the development and lifecycle management of patient-centric drug delivery systems. Reporting directly to the Senior Director of Device Development, this role accelerates the execution of both pipeline innovations and commercial product sustaining engineering across autoinjectors, pre-filled syringes, and wearable devices. The ideal candidate brings deep design control expertise, technical rigor, and a proven ability to translate complex clinical needs into safe, reliable combination products that transform patient outcomes.

Responsibilities

• Design Controls & Documentation: Author and maintain comprehensive Design History Files (DHF) and Device Master Records (DMR), establishing robust design inputs, output specifications, verification/validation strategies, and complete traceability.
• Risk Management & Quality Alignment: Translate clinical use scenarios and human factors observations into comprehensive risk assessments per ISO 14971, ensuring direct alignment with design input requirements and risk-based test protocols.
• Technical Root Cause Investigation: Lead complex technical investigations and engineering failure analyses to resolve device and component issues, evaluating supplier deviations, customer complaints, and change control impact assessments.
• External Partner & CDMO Oversight: Direct technical workstreams with external partners, including component manufacturers, contract research organizations (CROs), and contract manufacturing organizations (CMOs); oversee protocol execution, data analysis, and report generation at external laboratories.
• Sustaining & NPI Engineering: Execute engineering analyses—including first-principles physics modeling, FEA, and empirical testing—to support both new product introductions (NPI) and lifecycle management changes for commercialized delivery platforms.
• Regulatory Compliance & Strategy: Prepare rigorous technical content and justifications for regulatory submissions (e.g., 510(k), PMA, MAA) and directly support responses to global regulatory inquiries.
• Process Modernization & Innovation: Leverage modern engineering frameworks (DFSS, DFM, DOE) and integrate AI-enabled workflow tools to streamline problem-solving, optimize technical documentation, and drive pipeline efficiency.

Qualifications

• Bachelor of Science in Biomedical, Mechanical, Electrical, or a related engineering discipline.
• 6+ years of medical device or combination product development experience, including 3+ years specifically focused on drug delivery platforms (e.g., autoinjectors, pre-filled syringes, wearable injectors, pen injectors, or reconstitution systems).
• Thorough mastery of combination product regulatory standards and quality frameworks, including 21 CFR Part 4, ISO 13485, ISO 14971, 510(k)/PMA pathways, and EU MDR/MDD requirements.
• Proven track record in prototype evaluation, engineering analysis (FEA, first-principles modeling), test method development, and hands-on laboratory troubleshooting.
• Strong cross-functional communication skills with demonstrated success managing technical deliverables with third-party suppliers and CDMOs.

Preferred

• Master's degree or Ph.D. in Biomedical, Mechanical, or Electrical Engineering.
• Experience utilizing requirements management and traceability tools such as JAMA, IBM DOORS, Polarion, or CodeBeamer.
• Practical fluency with AI tools to accelerate engineering workflows, data analysis, and technical documentation.
• End-to-end experience guiding a drug-device combination product from early-stage design concept through commercial market entry.
• Expertise in connected health platforms, electromechanical drug delivery devices, and handheld digital technologies.
• Demonstrated mastery of Design for Six Sigma (DFSS), Design for Manufacturability (DFM), and Design of Experiments (DOE) methodologies.