Senior Device Development Lead, Combination Products

Oruka Therapeutics Inc; Waltham (MA); Hybrid; USD 146,000 - 161,000; Full time

Benefits offered by this job

Competitive salary and equity

Professional growth opportunities

Inclusive startup culture

Job summary

Oruka Therapeutics in Waltham, MA is seeking a Senior Engineer/Manager, Device Development — Combination Products to lead hands-on device engineering and program leadership for autoinjector and prefilled-syringe programs within the drug asset pipeline.

Reporting to the Director of Device Development, you will own design controls, DHF, risk management per ISO 14971, manage external partners, drive timelines and budgets, and mentor a cross-functional team to deliver scalable device solutions.

Qualifications

• BS or MS in Mechanical, Biomedical, or related Engineering discipline.
• 5–7 years in device development within pharma/biotech/medical devices.
• Experience with combination products (autoinjectors, prefilled syringes, wearable injectors).

Responsibilities

• Provide hands-on technical leadership for device programs (autoinjector, prefilled-syringe).
• Own design controls, DHF content, verification/validation, and risk management per ISO 14971.
• Manage external suppliers, vendors, and CDMOs/CMOs, plus technology transfer.
• Lead program timelines, budgets, risk registers, and readiness reviews for device workstreams.
• Collaborate with cross-functional teams and regulatory to support submissions.

Skills

Device development

Combination products

Project management

Supplier management

Human factors awareness

Education

BS/MS in Mechanical or Biomedical Engineering

Tools

SolidWorks

Regulatory standards (FDA/ISO)

Job description

Oruka Therapeutics in Waltham, MA is seeking a Senior Engineer/Manager, Device Development — Combination Products to lead hands-on device engineering and program leadership for autoinjector and prefilled-syringe programs within the drug asset pipeline.

Reporting to the Director of Device Development, you will own design controls, DHF, risk management per ISO 14971, manage external partners, drive timelines and budgets, and mentor a cross-functional team to deliver scalable device solutions.