Senior Device Development Lead - Combination Products

Oruka Therapeutics Inc

Boston (MA)

Hybrid

USD 146,000 - 161,000

Full time

6 days ago

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Benefits offered by this job

Hybrid work model

Competitive compensation

In-office 3 days/week

Job summary

Oruka Therapeutics Inc. in Waltham, MA is seeking a Senior Engineer/Manager, Device Development to provide hands-on technical leadership for combination product programs (autoinjector, prefilled-syringe).

You will own design controls, cross-functional coordination, and external supplier relationships, with on-site leadership and strategic input to regulatory submissions. The role emphasizes program management, MSAT support, and collaboration with Quality, Regulatory, and Clinical teams to

Qualifications

BS or MS in Mechanical, Biomedical, or related Engineering.
5–7 years of device development experience in pharmaceutical, biotech, or medical device industries.
Experience with combination products (autoinjectors, prefilled syringes, on-body/wearable injectors).
Knowledge of ISO 13485, FDA 21 CFR Part 4 and 820, IEC 62366-1, ISO 11608, ISO11040, and ISO 14971 (risk management).

Responsibilities

Serve as day-to-day technical lead for one or more combination device programs (autoinjector, prefilled-syringe).
Own program timelines, budgets, and risk registers for device development workstreams.
Manage external suppliers, CDMOs/CMOs and quality agreements.
Provide MSAT leadership for device manufacturing campaigns and on-site oversight.
Collaborate with Quality, Regulatory, and Clinical teams on submissions and lifecycle activities.