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

Oruka Therapeutics•Waltham, MA

4d•$182,000 - $240,000•Hybrid

About The Position

Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. For more information, visit www.orukatx.com As we build our core team, we're seeking top talent in different functional areas who are not just looking for a job, but an opportunity to be part of something bigger. Someone who is passionate about making a difference and eager to contribute to establishing an engaged, inclusive, and positive company culture. 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
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
Experience with biologics delivery systems preferred

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.

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