Senior Engineer/Manager, Device Development — Combination Products at Oruka Therapeutics in Waltham, MA

Job description

About Us: 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. Job Title: Senior Engineer/Manager, Device Development — Combination Products Location: Hybrid, Waltham, MA – Candidates will be required to be in-office 3 days/week. Role Overview: We are seeking a Sr. Engineer/Manager, Device Development to provide hands-on technical and program leadership for one or more platform combination device programs, including autoinjector, and prefilled-syringe within Oruka’s drug asset pipeline. Working under the direction of the Director of Device Development, this role executes device engineering deliverables day to day and manages the tactical, working-level relationship with Oruka’s external device suppliers, vendors, and contract manufacturing (CDMO) partners. Device platform strategy, executive supplier relationships, and MSAT/PIP ownership sit with the Director/Sr. Director of DP Manufacturing and Device Development. Key Responsibilities: Device Technical Leadership Serve as the day-to-day technical lead for one or more assigned combination device programs (autoinjector, prefilled-syringe-based, or on-body/wearable injector systems). Execute device design control deliverables: design inputs/outputs, Design History File (DHF) content, verification and validation protocols/reports, and risk management files per ISO 14971. Support human factors and usability engineering activities per IEC 62366-1 and FDA guidance, planning and running formative studies and supporting summative (validation) studies led by HFE/the Associate Director. Execute device platform standardization initiatives, evaluating component and process options at the program level. Review and disposition device engineering changes, non-conformances, and CAPAs for assigned programs. Program & Project Management Own program timelines, budgets, and risk registers for assigned device development workstreams. Drive stage-gate deliverables and readiness reviews for assigned programs, in partnership with Combination Product and Program Management. Manage cross-functional project plans, track critical path, and flag schedule or technical risks to the Associate Director/Director. Report program status and risks in team and program reviews. External Supplier, Vendor & CDMO Management Support selection and qualification of device component suppliers and device CDMOs/CMOs Own the day-to-day, working-level technical relationship with external partners — technical oversight of device design, tooling, process development, and scale-up execution. Support negotiation and administration of quality agreements, technical agreements, and statements of work. Execute technology transfer activities from development through commercial manufacturing, escalating strategic decisions as needed. Track supplier performance and quality metrics day to day and drive resolution of routine technical or quality issues. MSAT & Manufacturing Support Provide MSAT leadership for clinical and commercial device and combination-product manufacturing, including engineering, clinical, PPQ, and