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

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

Location: Hybrid – Waltham, MA. Candidates will be required to be in-office 3 days/week. Remote may be considered. 

Position Summary

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.

Key Responsibilities

Device & Combination Product Development

• 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

Human-Centered Design & Human Factors Engineering

• 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

Technical Leadership

• 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

MSAT & Manufacturing Support

• 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

Regulatory & Quality

• 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

Qualifications

Education

• PhD, or MS in Biomedical Engineering, Mechanical Engineering, or related field

Experience

• 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

Technical Expertise

• 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

Leadership & Collaboration

• 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

Preferred Qualifications

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

Additional Requirements

• Ability to travel up to 20%, including visits to manufacturing sites, external partners, and testing facilities

Compensation:

• An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.
• The anticipated salary range for candidates, who will work in Waltham, MA is $182,000-208,000 for Associate Director and $213,000-240,000 for Director. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.

We're looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.