{"id":1671338,"url":"https://alion.io/job/oruka-senior-engineermanager-device-development-combination-products","title":"Senior Engineer/Manager, Device Development — Combination Products","company":{"id":688198,"name":"Oruka","domain":"oruka.com","url":"https://alion.io/company/oruka","size_band":"1-10","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":{"grade":"A","score":86,"open_postings":11,"ghost_share":0,"stale_share":0.545,"repost_share":0,"time_to_fill_p50_days":null,"computed_at":"2026-10-02T05:45:00Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"senior","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Waltham, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":146000,"max":161000,"currency":"USD","period":"year","gross":null,"usd_annual":161000},"salary_estimate":null,"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"SolidWorks","optional":false}],"status":"live","first_seen_at":"2026-10-01T22:28:02Z","employer_posted_date":"2026-10-01","last_verified_at":"2026-10-02T20:45:06Z","board_verified":true,"closed_at":null,"days_open":1,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":1},"description":"About Us: \nOruka 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\nAs 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. \nJob Title: Senior Engineer/Manager, Device Development - Combination Products \nLocation: Hybrid, Waltham, MA - Candidates will be required to be in-office 3 days/week. \nRole Overview:\nWe 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.\nWorking 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.\nKey Responsibilities: \nDevice Technical Leadership\nServe 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).\nExecute device design control deliverables: design inputs/outputs, Design History File (DHF) content, verification and validation protocols/reports, and risk management files per ISO 14971.\nSupport 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.\nExecute device platform standardization initiatives, evaluating component and process options at the program level.\nReview and disposition device engineering changes, non-conformances, and CAPAs for assigned programs.\nProgram & Project Management\nOwn program timelines, budgets, and risk registers for assigned device development workstreams.\nDrive stage-gate deliverables and readiness reviews for assigned programs, in partnership with Combination Product and Program Management.\nManage cross-functional project plans, track critical path, and flag schedule or technical risks to the Associate Director/Director.\nReport program status and risks in team and program reviews.\nExternal Supplier, Vendor & CDMO Management\nSupport selection and qualification of device component suppliers and device CDMOs/CMOs\nOwn the day-to-day, working-level technical relationship with external partners - technical oversight of device design, tooling, process development, and scale-up execution.\nSupport negotiation and administration of quality agreements, technical agreements, and statements of work.\nExecute technology transfer activities from development through commercial manufacturing, escalating strategic decisions as needed.\nTrack supplier performance and quality metrics day to day and drive resolution of routine technical or quality issues.\nMSAT & Manufacturing Support\nProvide MSAT leadership for clinical and commercial device and combination-product manufacturing, including engineering, clinical, PPQ, and commercial campaigns.\nServe as Person-in-Plant, providing on-site technical oversight and rapid issue resolution.\nPartner with CMOs and internal teams to lead technology transfer, scale-up, investigations, deviations, CAPAs, and continuous process improvement.\nCross-Functional & Regulatory Collaboration\nPartner with Quality, Regulatory Affairs, CMC/Drug Product, Clinical Supply, and Supply Chain on device-related deliverables for assigned programs.\nAuthor and support device-related content for combination product regulatory submissions (IND, NDA/BLA, design dossiers).\nSupport Commercial and Marketing on device user needs and post-launch lifecycle activities for assigned programs.\nQualifications:\nEducation\nBS or MS in Mechanical, Biomedical, or related Engineering discipline.\nExperience\n5-7 years of relevant device development experience in pharmaceutical, biotech, or medical device industries.\nDirect, hands-on experience developing combination products (drug-device), such as autoinjectors, prefilled syringes, on-body/wearable injectors, or similar parenteral delivery systems.\nTechnical Expertise\nStrong knowledge of:\nDesign 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).\nWorking with external device suppliers, vendors, and/or CDMOs on technical execution, tooling, process development, or manufacturing scale-up.\n3D Modeling expertise using Solidworks or equivalent platform\nLeadership & Collaboration\nDemonstrated project management skills, including timeline and risk management within a cross-functional, matrixed team.\nStrong written and verbal communication skills.\nSupplier relationship development and project leadership without direct reporting\nTeam building skills a plus\nPreferred Qualifications\nPrior experience contributing to human factors/usability studies (formative or summative).\nExperience supporting a program from development through clinical or commercial launch.\nExposure to device platform standardization efforts across multiple drug assets.\nFamiliarity with injectable biologics and parenteral drug product development.\nExperience as (or supporting) a Person-in-Plant (PIP) during manufacturing campaigns.\nAdditional Requirements\nAbility to travel approximately 20-30%, including visits to device suppliers and CDMO/manufacturing sites in Asia, US and EU.\nCompensation:\nAn appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.\nThe 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.\nWe'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.\nSalary Range for the Role\n$146,000—$161,000 USD\nWhat We Offer:\nA chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.\nCompetitive salary and benefits package.\nA supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work.\nOpportunities for professional growth and development.","description_format":"text","description_chars":7616,"description_truncated":false,"requirements":{"experience_years_min":5,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"master","optional":false},"security_clearance":false,"languages":[]},"benefits":["Equity"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":[],"lifecycle":[{"event":"open","at":"2026-10-02T06:48:10Z"}],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":1,"expected_fill_days":25,"reasons":["conf:6","win:early"],"computed_at":"2026-10-03T03:37:26Z"},"pay":{"stated_usd_annual":161000,"is_top_pay":true},"html_url":"https://alion.io/job/oruka-senior-engineermanager-device-development-combination-products","json_url":"https://alion.io/job/oruka-senior-engineermanager-device-development-combination-products.json","meta":{"generated_at":"2026-10-03T03:37:26Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","usage":{"tier":"crawler","counted_by":"address","units_charged":1,"used_today":3610,"day_limit":5000,"remaining_today":1390,"minute_limit":60,"resets_at":"2026-10-04T00:00:00Z"}}}