Associate Director / Director, Device Development (Prefilled Syringes & Auto-Injectors)

Oruka Therapeutics • Waltham, MA

4d • $182,000 - $240,000 • Hybrid

About The Position

We are seeking an experienced and driven Associate Director or Director of Device Development to lead the end-to-end development of drug delivery systems, with a focus on prefilled syringes and auto-injectors for late-stage programs and commercialization. This role will be responsible for integrating medical device engineering, human-centered design, and human factors engineering into combination product development, ensuring safe, effective, and patient-friendly delivery solutions. The ideal candidate brings deep expertise in biomedical engineering, device development, and regulatory requirements for combination products, along with a track record of advancing programs from clinical stages through commercial launch.

Requirements

• PhD, or MS in Biomedical Engineering, Mechanical Engineering, or related field
• Associate Director: 8+ years of relevant experience
• Director: 12+ years of relevant experience
• Significant experience in combination products and drug delivery devices, particularly prefilled syringes and/or auto-injectors
• Proven track record supporting late-stage development and commercialization
• Strong knowledge of: Medical device design and development processes, Human factors engineering / usability engineering, Risk management, Design controls and validation requirements, MSAT and manufacturing support for combination products
• Experience with biologics delivery systems preferred
• Demonstrated ability to lead cross-functional, matrixed teams
• Strong communication skills with experience influencing senior leadership and external partners
• Strategic mindset with the ability to balance technical depth and business objectives
• Ability to travel up to 20%, including visits to manufacturing sites, external partners, and testing facilities

Nice To Haves

• Experience with regulatory interactions (FDA, EMA) for combination products
• Background in patient-centric design
• Experience with commercial device manufacturing and supply chain management

Responsibilities

• Lead development of prefilled syringes, auto-injectors, and related delivery systems from late-stage clinical development through commercialization
• Define and execute device development strategies, including design, verification, validation, and lifecycle management
• Oversee combination product integration, ensuring alignment with CMC, clinical, and regulatory strategies
• Drive human-centered product development, incorporating patient, caregiver, and healthcare provider needs
• Lead human factors engineering (HFE) activities, including use-related risk analysis, formative and summative (validation) studies
• Ensure compliance with FDA, EMA, and global HFE/usability requirements
• Provide subject matter expertise in biomedical engineering and device technologies
• Lead cross-functional teams across development, clinical, regulatory, quality, and manufacturing
• Independently manage external partners, including device manufacturers, design firms, and testing laboratories
• Provide MSAT leadership for device and combination product manufacturing across clinical and commercial stages
• Serve as Person-in-Plant (PIP) during manufacturing campaigns, ensuring on-site technical oversight and rapid issue resolution
• Lead and support manufacturing campaigns, including engineering runs, clinical, PPQ, and commercial production
• Partner with CMOs and internal teams to ensure robust manufacturing processes, tech transfer, and scale-up
• Drive investigations, deviations, CAPAs, and continuous process improvements related to device and combination product manufacturing
• Support regulatory submissions (e.g., IND, BLA) with device-related content
• Ensure compliance with combination product regulations (21 CFR Part 4, ISO 13485, IEC 62366, ISO 14971)
• Partner with Quality to ensure design controls and risk management processes are implemented effectively

Benefits

• A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.
• Competitive salary and benefits package.
• A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work.
• Opportunities for professional growth and development.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree
• Number of Employees: 1-10 employees