{"id":1006784,"url":"https://alion.io/job/takeda-sr-staff-device-engineer","title":"Sr Staff Device Engineer","company":{"id":5984,"name":"Takeda Pharmaceutical","domain":"takeda.com","url":"https://alion.io/company/takeda","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"A","score":87,"open_postings":62,"ghost_share":0,"stale_share":0.468,"repost_share":0.065,"time_to_fill_p50_days":26,"computed_at":"2026-11-04T06:34:25Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"staff","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Lexington, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":137000,"max":215270,"currency":"USD","period":"year","gross":null,"usd_annual":215270},"salary_estimate":null,"experience_years_min":8,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"Design Controls","optional":false},{"name":"Design History File","optional":false},{"name":"GMP","optional":false},{"name":"ISO 13485","optional":false},{"name":"ISO 14971","optional":false},{"name":"Verification & Validation","optional":false}],"status":"live","first_seen_at":"2026-08-26T00:00:00Z","employer_posted_date":"2026-10-27","last_verified_at":"2026-11-04T06:56:50Z","board_verified":true,"closed_at":null,"days_open":70,"trust":{"level":"ok","repost_count":1,"flags":[],"days_open":70},"description":"By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.\nJob Description\nAbout the role:\nAt Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on three therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.\nJoin Takeda as a Sr. Staff Device Engineer where you will be recoganized as a device SME of combination product device on the Commercial Device Engineering (CDE) team accountable for all the technical aspects of the on-market combination product lifecycle management. You will also be responsible for change controls, manufacturing process validation, device product complaints, regular review of DHF, and post-market surveillance as related to on-market products. As part of the CDE team, you will report to Director, Commercial Device Engineering and work with external CLO and CMO.\nThe on-market combination products enhance patient and medical professional experiences with Takeda’s medicinal drug products. In particular, the Sr. Staff Device Engineer has experience in drug delivery devices/systems and understanding of manufacturing process in global standards for the combination products.\nHow you will contribute:\nYou will work as commercial device technical lead working with cross functional team to support lifecycle management of commercial combination product.\nThis CDE position is within Takeda’s Drug Product Device Development and will work closely with drug product, quality, regulatory, program leadership, etc. The successful candidate will work in a cross functional environment and establish strategic working relationships.\nConduct technical investigations, analyze technical aspects related to the manufacturing processes and/or commercial expansion.\nOversight of commercial device qualification processes, coordinate tech transfer of verification and validations related to technology transfer of new drug delivery devices, and solve technical issues related to commercial products.\nProvide input to change controls, MDR, and post-market surveillance reports.\nLead gap assessments / remediation as needed and guide technical aspects of risk management activities. Lead products’ projects within budget for defined activities.\nComplaint handling including SME evaluation root cause analysis, CAPA, change control.\nDesign control process, specification creation, design verification and validation, design transfer, test protocol and report generation.\nManufacturing expansion, process validation.\nQuality regulation system, DHF, MDR, ISO13485, ISO14971.\nEnsured Compliance with appropriate device and combination product regulations and Takeda policies.\nMinimum Requirements/Qualifications:\nPhDdegreeinMechanicalEngineering,ElectricalEngineering,BiomedicalEngineering,orarelatedtechnicaldisciplinewithaminimumof3yearsofrelevantexperience;Master'sdegreewithaminimumof5yearsofrelevantexperience;orBachelor'sdegreewithaminimumof8yearsofrelevantexperience.\n\nSME in medical devices, particularly drug delivery systems, with technical leadership to manage drug delivery device commercialized products such as PFS, pen injector, Autoinjector, Needle Safety Device, etc.\nKnowledge in design controls and quality system requirements.\nTechnical expertise in combination product with focus on life cycle management including complaint handling, change control, manufacturing expansion, and quality and regulatory supports. \nKnowledge and application of cGMP requirements and demonstrated application of industry guidance/standards document and Regulatory combination product guidance documents applicable to the role. Strong problem solving skills, excellent communication and cognitive skills.\nGood understanding of manufacturing process and packaging constructions methods. Ability to work in team, fulfills commitments and managing multiple stakeholders. Experience in drafting portions of combination product technical content. Proven ability to author user requirement specifications, technical protocols, reports and assessments. Previous project team experience with technology transfer. Hands on experience with the concept development and feasibility testing, test method development and test method validation.\nTechnical leadership for high performing teams, with strong ability to meet timelines, work effectively cross functionally and expertly advise key stakeholders.\nExperience in medical device LCM: change controls, device complaint investigations and post-market surveillance\nWhat Takeda can offer you:\nComprehensive Healthcare: Medical, Dental, and Vision\nFinancial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan\nHealth & Wellness programs including onsite flu shots and health screenings\nGenerous time off for vacation and the option to purchase additional vacation days\nCommunity Outreach Programs and company match of charitable contributions\nFamily Planning Support\nFlexible Ways of Working\nTuition reimbursement\nTakeda Compensation and Benefits Summary\nWe understand compensation is an important factoras you consider the next step in your career. We are committed to equitablepay for all employees, and we strive to be more transparent with our pay practices.\nFor Location:\nLexington, MAU.S. Base Salary Range:\n$137,000.00 - $215,270.00The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.\nFor information about our benefits, please click here.\nEEO Statement\nTakeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.\nLocations\nLexington, MAWorker Type\nEmployeeWorker Sub-Type\nRegularTime Type\nFull timeJob Exempt\nYesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. 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