Director, Combination Product & Device Development

Role Overview 

We are seeking highly skilled, and motivated Director of Combination Product & Device Development, to lead the development, manufacturing, assembly and commercialization of high‑concentration biologic delivery systems, including, prefilled syringes, autoinjectors and other drug–device combination products.

The ideal candidate brings deep expertise in device design control, verification and validation, risk management, combination product regulations, and human factors engineering. This role requires hands‑on technical leadership and extensive experience with regulated devices and combination products (21 CFR 820, ISO 13485), as well as strong knowledge of global device standards (ISO, IEC 62366, ANSI/AAMI HE75) and FDA guidance. A successful track record supporting major regulatory submissions (BLA, MAA, IND/IMPD) and notified body assessments is essential.

Key Responsibilities 

Device Development

• Lead end‑to‑end development and commercialization of prefilled syringes, dual‑chamber cartridges, autoinjectors, and related combination product systems.
• Serve as a hands‑on technical leader and device SME across concept, feasibility, development, qualification, and launch phases.
• Define user needs and product requirements; lead prototyping, test method development, and design verification and validation (DV/V) activities.
• Drive design control documentation, risk assessments, usability studies, and human factors integration.
• Collaborate deeply with internal partners across CMC, drug product development, quality assurance, regulatory affairs, clinical development, supply chain, and commercial functions.
• Build and manage external relationships with CDMOs, device manufacturers, design firms, and suppliers to support development and lifecycle needs.
• Support lifecycle management of commercial combination products, including design history file (DHF) maintenance, change control, validation activities, complaint investigations, and post‑market surveillance.
• Evaluate technical decisions for cross‑functional impact and implement contingency plans as needed.
• Proactively identify and address manufacturing issues; coordinate technical solutions across internal and external teams.
• Lead creation of design control deliverables to ensure compliance with global device and combination product regulations.
• Oversee development of statistically sound verification protocols, reports, and design validation strategies.
• Lead or contribute to investigations of deviations, failures, complaints, and device‑related quality issues.

Design Controls & Human Factors

• Serve as the organizational expert in Human Factors Engineering, ensuring compliance with IEC 62366, ANSI/AAMI HE75, FDA guidance, and related industry standards.
• Integrate usability, human performance considerations, and safety risk mitigations into system requirements and development strategies.
• Ensure all human factors processes, deliverables, and standards are appropriately documented within the Design Control Quality System.
• Lead the cross‑functional design control sub‑team and drive cohesive integration across device design, analytical testing, packaging, manufacturing, clinical, supply chain, commercial, and regulatory functions.
• Manage and prioritize multiple concurrent projects, ensuring alignment to scope, timelines, budgets, and quality standards.

Regulatory Support

• Ensure compliance with global combination product and medical device regulations, including FDA and EU frameworks (e.g., EDDO, MDR).
• Author device‑related sections for regulatory submissions (BLA, MAA, IND/IMPD) and support notified body interactions.
• Represent the combination product function during regulatory audits and inspections.
• Lead proactive risk identification, mitigation planning, and escalation of critical issues.
• Demonstrate strong understanding of FDA’s Office of Combination Products (OCP), including primary mode of action (PMOA) requirements and combination product complaint expectations.

Qualifications 

• Master’s degree (or equivalent) in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, or a related field.
• 15+ years of experience in biologic delivery device development with a proven record of supporting late‑stage development and commercial product launches.

• Experience with design controls, device risk management, medical devices, prefilled syringes, autoinjectors, and related scientific and technical concepts and techniques is required for this position.
• Deep knowledge of subcutaneous delivery systems, systems engineering principles, device materials, and manufacturing technologies; experience with biologics and packaging development preferred.
• Strong understanding of FDA and EU regulations for medical devices and combination products, including relevant quality systems and standards.
• Experience managing external partners, vendors, and contract manufacturers.
• Proven experience with cGMP process development, manufacturing controls, and process risk assessments.
• Excellent communication, leadership, and cross‑functional collaboration skills.
• Ability to thrive in a fast‑paced, agile environment; start‑up experience is highly desirable.

Position Location 

This is a fully remote role with up to 15-20% domestic and/or international travel.

The anticipated salary range for candidates for this role is $210,000 - $235,000. The final salary offered will depend on several factors, which may include, but not limited to, relevant years of experience, educational background, and geography.