{"id":1565827,"url":"https://alion.io/job/amgen-sr-engineer-combination-product-inhalation-device-lead","title":"Sr. Engineer - Combination Product Inhalation Device Lead","company":{"id":4775,"name":"Amgen","domain":"amgen.com","url":"https://alion.io/company/amgen","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":79,"open_postings":451,"ghost_share":0.002,"stale_share":0.836,"repost_share":0.007,"time_to_fill_p50_days":27,"computed_at":"2026-10-21T05:46:15Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"lead","employment_type":"full_time","work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Cambridge, United States","Thousand Oaks, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":127044,"max":171883,"currency":"USD","period":"year","gross":null,"usd_annual":171883},"salary_estimate":null,"experience_years_min":4,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Design Controls","optional":false},{"name":"Design History File","optional":false}],"status":"live","first_seen_at":"2026-09-29T00:00:00Z","employer_posted_date":"2026-09-29","last_verified_at":"2026-10-21T23:04:58Z","board_verified":true,"closed_at":null,"days_open":23,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":23},"description":"Career Category\nEngineeringJob Description\nJoin Amgen’s Mission of Serving Patients\nAt Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.\nSince 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.\nOur award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.\nSr. Engineer - Combination Product Inhalation Device Lead\nWhat you will do\nLet’s do this. Let’s change the world. In this vital role you will join the Combination Product Development and Transformation (CPD&T) team to lead systems engineering and device development activities for dry powder inhaler (DPI) combination products. In support of Amgen's mission to serve patients, the CPD&T team develops drug-device combination products to support Amgen’s portfolio of drugs and biologics for patient-centric drug delivery. The Sr. Engineer will provide technical leadership across combination-product design controls, translating user and patient needs and product objectives into robust system and device requirements, interface definitions, design outputs, verification strategies, and integrated drug-device-capsule solutions.\nThe Sr. Engineer will own and drive key Design History File (DHF) and Design and Development Plan (DDP) activities for the DPI device constituent, including needs and requirements engineering, system and subsystem interface definition, design reviews, design verification strategy, configuration management, and change control. The role will apply EDDO / delivery-output thinking to identify and control the device outputs most important to dose delivery, aerosolization, usability, and overall combination-product performance, and will maintain clear traceability from needs and requirements through risk controls, design outputs, verification, and supporting evidence.\nThe Sr. Engineer will also lead technical integration of supplier-provided DPI platforms and evidence. This includes assessing the applicability of supplier design, verification, manufacturing, and master-file (MAF) evidence; identifying gaps and appropriate bridging needs; and providing technical oversight of device suppliers. The role will partner closely with other combination product SMEs, as well as drug product, analytical and methods, regulatory, quality, manufacturing, clinical, human factors, and other development teams to integrate DPI device design and airflow characteristics, aerosolization fundamentals, capsule-device interactions, and drug-device-capsule performance into the product development strategy.\nThe Sr. Engineer will also:\n· Lead combination-product systems engineering and device development for DPI programs, including system architecture, needs and requirements engineering, interface definition, technical trade-offs, integration planning, and design reviews.\n· Own or lead DHF/DDP deliverables for the DPI device constituent and ensure design-control documentation is complete, coherent, configuration-controlled, and aligned with the evolving combination-product design.\n· Establish and maintain end-to-end traceability among user and product needs, system and device requirements, EDDO / delivery outputs, risk controls, design outputs, verification activities, and objective evidence.\n· Develop the design verification strategy for the DPI device and integrated combination product, including rationale for use of supplier evidence, platform knowledge, bridging, analysis, and product-specific testing.\n· Apply DPI platform knowledge and inhalation fundamentals, including device resistance, airflow, aerosolization and powder-dispersion behavior, in partnership with analytical and methods teams to support device selection, development, and performance understanding.\n· Lead drug-device-capsule integration, defining and managing critical interfaces among the dry-powder drug product, capsule, inhaler, and user to achieve reliable dose delivery and aerosol performance.\n· Assess supplier technical evidence and MAF applicability, identify evidence gaps and bridging needs, and provide technical oversight of device suppliers, including design changes, investigations, verification evidence, and lifecycle support.\n· Coordinate with regulatory, quality, drug product, analytical, manufacturing, clinical, human factors, suppliers, and other cross-functional stakeholders to support technical decisions, submissions, issue resolution, and lifecycle changes.\nWhat we expect of you\nWe are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.\nBasic Qualifications:\nDoctorate degree\nOR\nMaster’s degree and 2 years of Engineering experience\nOR\nBachelor’s degree and 4 years of Engineering experience\nOR\nAssociate’s degree and 8 years of Engineering experience\nOR\nHigh school diploma / GED and 10 years of Engineering experience\nPreferred Qualifications:\n· Direct experience developing capsule-based or other dry powder inhaler platforms and combination products from early development through design verification and regulatory submission.\n· Experience with aerosol performance characterization and methods such as delivered dose uniformity, aerodynamic particle size distribution, device resistance/pressure-flow characterization, or related inhalation testing.\n· Experience assessing supplier design-history, verification, manufacturing, and master-file evidence, including applicability/bridging decisions and letters of authorization where applicable.\n· Experience supporting FDA or global regulatory submissions for drug-device combination products, including technical responses, design-control evidence, and device constituent documentation.\n· Experience providing technical oversight of external device suppliers and leading cross-functional resolution of device performance, integration, manufacturing, or lifecycle issues.\n· Knowledge of fluid dynamics, aerosol science, particle dispersion/deagglomeration, or modeling approaches relevant to DPI device performance.\n· Experience with platform-device strategies, configuration/change control, and risk-based bridging of device evidence across products or presentations.\nExperience providing technical mentoring or serving as a subject matter expert in combination-product systems engineering, device development, or inhalation delivery systems\nWhat you can expect of us\nAs we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.\nThe expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.\nIn addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:\nA comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts\nA discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan\nStock-based long-term incentives\nAward-winning time-off plans\nFlexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.\nApply now and make a lasting impact with the Amgen team.\ncareers.amgen.com\nIn any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.\nApplication deadline\nAmgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.\n\nSponsorship\nSponsorship for this role is not guaranteed.\nAs an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.\nAmgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.\nWe will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.\n.Salary Range\n127,044.40USD -171,883.60 USD","description_format":"text","description_chars":10034,"description_truncated":false,"requirements":{"experience_years_min":4,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"high_school","optional":false},"security_clearance":false,"languages":[]},"benefits":["Flexible schedule","Retirement plans"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[{"name":"Puerto Rico","iso":"PR"}],"relocation_offered":false,"industries":["Infusion & Drug Delivery Devices","Biotechnology","Health Care","Immunology & Inflammation Therapeutics"],"lifecycle":[{"event":"open","at":"2026-10-01T06:01:42Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 372 · green card filings: 113","filings_12m":372,"filings_prev_12m":465,"green_card_filings_12m":113,"median_offered_wage_usd":136675,"route":null,"cap_exempt":false,"checked_at":"2026-10-15T11:24:14+00:00","sources":["US Department of Labor: LCA disclosure data (H-1B, H-1B1, E-3)","US Department of Labor: PERM disclosure data (green cards)"],"filings_for_role_12m":0}],"liveness":{"score":38,"band":"fade","label":"Fading","p_open":0.9,"p_active":0.562,"p_room":0.75,"age_days":22,"expected_fill_days":27,"reasons":["conf:60","stale_co","velocity","win:late","comp:brand"],"computed_at":"2026-10-21T05:46:15Z"},"pay":{"stated_usd_annual":171883,"is_top_pay":true},"html_url":"https://alion.io/job/amgen-sr-engineer-combination-product-inhalation-device-lead","json_url":"https://alion.io/job/amgen-sr-engineer-combination-product-inhalation-device-lead.json","meta":{"generated_at":"2026-10-22T00:31:57Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":782,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-23T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":4775},"rest":"https://alion.io/mcp/rest/get_company?id=4775"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Famgen-sr-engineer-combination-product-inhalation-device-lead"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Famgen-sr-engineer-combination-product-inhalation-device-lead"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Famgen-sr-engineer-combination-product-inhalation-device-lead"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/amgen-sr-engineer-combination-product-inhalation-device-lead\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Famgen-sr-engineer-combination-product-inhalation-device-lead"}]}