Oruka Therapeutics

Associate Director – Device Development, Prefilled Syringes & Auto-Injectors

Oruka Therapeutics

full-time

Posted on:

Location Type: Hybrid

Location: Waltham • Massachusetts • United States

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Salary

💰 $182,000 - $240,000 per year

Job Level

Senior

About the role

  • 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.
  • 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).

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.
  • Strong knowledge of human factors engineering / usability engineering.
  • Strong knowledge of risk management.
  • Strong knowledge of design controls and validation requirements.
  • Strong knowledge of MSAT and manufacturing support for combination products.
Benefits
  • Competitive salary and benefits package.
  • Opportunities for professional growth and development.
  • A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.
  • A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
biomedical engineeringdevice technologieshuman factors engineeringrisk managementdesign controlsvalidation requirementsMSATmanufacturing supportcombination productsdrug delivery devices
Soft Skills
leadershipcross-functional team managementcommunicationstrategic planningproblem-solvingcollaborationproject managementindependent management
Certifications
PhD in Biomedical EngineeringMS in Biomedical EngineeringMS in Mechanical Engineering