Senior Device Development Lead, Combination Products

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

Benefits offered by this job

Competitive salary package

Inclusive team environment

Professional growth opportunities

Job summary

Oruka Therapeutics Inc. in Waltham, MA is seeking a Senior Engineer/Manager, Device Development to lead hands-on technical development for combination product programs (autoinjector, prefilled syringe) within the drug asset pipeline.

Reporting to the Director/Sr. Director, you will drive design controls, DHF content, verification/validation, and risk management per ISO 14971, IEC 62366-1 guidance, and FDA expectations.

Qualifications

• BS or MS in Mechanical, Biomedical, or related Engineering discipline.
• 5–7 years of relevant device development experience in pharma/biotech/medical device.
• Direct experience developing combination products (drug-device) such as autoinjectors or prefilled syringes.
• Strong knowledge of design controls and ISO 13485, FDA 21 CFR Part 4/820, IEC 62366-1, ISO 11608/11040, ISO 14971.
• Experience with external suppliers and CDMOs; project leadership without direct reporting.
• Willingness to travel 20–30%, including international sites.

Responsibilities

• Lead day-to-day technical development for one or more combination device programs.
• Execute design controls, DHF content, verification/validation, and risk management per ISO 14971.
• Support human factors/usability studies per IEC 62366-1 and FDA guidance.
• Drive program timelines, budgets, and risk registers.
• Own supplier relationships and technology transfer activities.
• Collaborate with Quality, Regulatory, Clinical Supply, and Supply Chain.

Skills

Device development

Project management

Cross-functional leadership

Regulatory knowledge

Education

BS or MS in Mechanical, Biomedical, or related Engineering

Tools

SolidWorks

Job description

Oruka Therapeutics Inc. in Waltham, MA is seeking a Senior Engineer/Manager, Device Development to lead hands-on technical development for combination product programs (autoinjector, prefilled syringe) within the drug asset pipeline.

Reporting to the Director/Sr. Director, you will drive design controls, DHF content, verification/validation, and risk management per ISO 14971, IEC 62366-1 guidance, and FDA expectations.