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Senior Engineer/Manager, Device Development — Combination Products

oruka

Waltham, Massachusetts, United States Posted 5d ago
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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 commercial campaigns. * Serve as Person-in-Plant, providing on-site technical oversight and rapid issue resolution. * Partner with CMOs and internal teams to lead technology transfer, scale-up, investigations, deviations, CAPAs, and continuous process improvement. Cross-Functional & Regulatory Collaboration * Partner with Quality, Regulatory Affairs, CMC/Drug Product, Clinical Supply, and Supply Chain on device-related deliverables for assigned programs. * Author and support device-related content for combination product regulatory submissions (IND, NDA/BLA, design dossiers). * Support Commercial and Marketing on device user needs and post-launch lifecycle activities for assigned programs. Qualifications: Education * BS or MS in Mechanical, Biomedical, or related Engineering discipline. Experience * 5–7 years of relevant device development experience in pharmaceutical, biotech, or medical device industries. * Direct, hands-on experience developing combination products (drug-device), such as autoinjectors, prefilled syringes, on-body/wearable injectors, or similar parenteral delivery systems. Technical Expertise Strong knowledge of: * Design controls and applicable standards/regulations: ISO 13485, FDA 21 CFR Part 4 and Part 820 (QMSR), IEC 62366-1, ISO 11608, ISO11040, and ISO 14971 (risk management). * Working with external device suppliers, vendors, and/or CDMOs on technical execution, tooling, process development, or manufacturing scale-up. * 3D Modeling expertise using Solidworks or equivalent platform Leadership & Collaboration * Demonstrated project management skills, including timeline and risk management within a cross-functional, matrixed team. * Strong written and verbal communication skills. * Supplier relationship development and project leadership without direct reporting * Team building skills a plus Preferred Qualifications * Prior experience contributing to human factors/usability studies (formative or summative). * Experience supporting a program from development through clinical or commercial launch. * Exposure to device platform standardization efforts across multiple drug assets. * Familiarity with injectable biologics and parenteral drug product development. * Experience as (or supporting) a Person-in-Plant (PIP) during manufacturing campaigns. Additional Requirements * Ability to travel approximately 20–30%, including visits to device suppliers and CDMO/manufacturing sites in Asia, US and EU. Compensation: * An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity. * The anticipated salary range for candidates, who will work in Waltham, MA is $146,000 to $161,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states. We're looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day. Salary Range for the Role $146,000—$161,000 USD What We Offer: * A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients. * Competitive salary and benefits package. * A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work. * Opportunities for professional growth and development.

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