Role Summary

The Associate Director of Product Engineering will serve as a key technical leader responsible for overseeing the design, development, and manufacturability of complex medical devices and combination products. This role manages programs from early concept through verification, validation, and transfer to manufacturing, while also supporting continuous improvement of existing products.

This position offers the opportunity to contribute to advanced cell‑based technologies within a high‑growth environment that values innovation, cross‑functional collaboration, and strong engineering leadership.

Core Responsibilities

1. Product & Technology Development

• Lead development of next‑generation combination products, including delivery systems, encapsulation technologies, and packaging.
• Translate user needs into engineering requirements and oversee progression from feasibility to final design.
• Plan and execute proof‑of‑concept work and verification/validation activities.

2. Process Development & Scale-Up

• Direct end‑to‑end development of manufacturing processes for device and combination product production.
• Identify opportunities to scale and optimize processes for both pilot and long‑term manufacturing.
• Resolve technical challenges related to materials, design robustness, and manufacturability.

3. Research & Innovation

• Provide technical leadership to research initiatives that support the product platform and technological road map.
• Maintain awareness of evolving trends in medical devices, combination product technologies, and preclinical/clinical advancements.

4. Design Controls & Regulatory Alignment

• Lead execution of design control activities including design planning, risk analysis (e.g., FMEAs), and documentation required for regulated product development.
• Ensure alignment with relevant quality management standards (e.g., QSR, ISO 13485).
• Contribute to technical documentation for regulatory submissions.

5. Team Leadership & Development

• Mentor engineering staff through clear expectations, strong communication, and consistent coaching.
• Foster a culture centered on accountability, technical excellence, and collaborative problem‑solving.

6. Sustaining Engineering & Operational Support

• Support ongoing manufacturing operations by troubleshooting equipment, performing root cause analyses, and implementing continuous improvements.
• Partner with cross-functional teams to sustain product quality and performance.

7. Documentation & Technical Communication

• Prepare and review technical documentation including SOPs, protocols, batch records, specifications, and engineering drawings.
• Communicate technical findings through reports, presentations, and scientific/technical forums.

Qualifications

Education

• B.S., M.S., or Ph.D. in Biomedical, Chemical, Mechanical, or related Engineering discipline.
• Equivalent education and experience combinations will be considered.

Technical Background

• 7+ years of professional experience in medical device engineering or combination product development.
• Demonstrated expertise in design controls, risk management, and regulated product development.
• Familiarity with aseptic processing, cell‑based systems, or device-biologic interfaces is beneficial.
• Experience with equipment qualification (IQ/OQ/PQ), verification/validation testing, and technical documentation in compliance‑driven environments.

Soft Skills & Leadership Capabilities

• Proven ability to lead teams within fast‑paced, cross-functional R&D settings.
• Strong written and verbal communication skills, capable of simplifying complex technical topics.
• Excellent attention to detail, sound judgment, and effective prioritization.
• Ability to work independently while maintaining alignment with organizational goals.

Work Environment Requirements

• Comfortable working in both laboratory and office environments while following standard safety practices.
• Ability to lift up to 20 pounds and maintain productivity in a dynamic setting.
• Willingness to work occasional weekends based on project demands.

Why Join This Opportunity

• Contribute to cutting‑edge innovations in device and cell‑based technologies.
• Join a team dedicated to scientific excellence, creative engineering, and high‑impact product development.
• Play a meaningful role in advancing programs with significant clinical relevance.
• Competitive compensation, benefits, and relocation support included.