{"id":3251810,"url":"https://alion.io/job/medela-principal-systems-engineer","title":"Principal Systems Engineer","company":{"id":1832456,"name":"Medela","domain":"medela.com","url":"https://alion.io/company/medela-com","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":null},"role":"MedTech","role_family":"MedTech","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":["McHenry, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":74000,"max_usd":185000,"period":"year","method":null,"sample_n":215},"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Design Controls","optional":false},{"name":"IEC 60601","optional":false},{"name":"ISO 13485","optional":false},{"name":"ISO 14971","optional":false},{"name":"MBSE","optional":false},{"name":"SysML","optional":false},{"name":"Verification & Validation","optional":false}],"status":"live","first_seen_at":"2026-09-28T00:00:00Z","employer_posted_date":"2026-09-28","last_verified_at":"2026-11-03T20:54:37Z","board_verified":true,"closed_at":null,"days_open":37,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":37},"description":"Principal Systems Engineer-Medical Devices\nLocation: McHenry, IL\nHybrid Work Schedule: Three days a week on-site in McHenry and two days from home office\nSalary starting at $140K plus bonus\nAre you an experienced hands-on Systems Engineer who enjoys solving complex technical challenges, developing innovative medical devices and bringing together multiple engineering disciplines to create successful products?\nMedela LLC, in McHenry, IL is seeking a Principal Systems Engineer to provide hands-on technical and architectural leadership for its Maternity Care and NICU product portfolio. This is an opportunity for a hands-on engineer who thrives on solving complex problems, influencing technical decisions and collaborating with talented engineering professionals.\nThe ideal candidate brings strong experience in complex electromechanical medical devices, systems architecture and requirements development, along with an understanding of embedded software and connected device technologies.\nThis is a highly collaborative, hands-on technical leadership position with the opportunity to influence product development across a diverse medical device portfolio.\nWhat You'll Do-Principal Systems Engineer, Medical Devices\nLead the development of system architectures for complex electromechanical medical devices, including new product development, existing product improvements and system integration initiatives.\nTranslate customer, clinical and business needs into clear, measurable system and subsystem requirements.\nDevelop and maintain system architectures, interface specifications and technical documentation across hardware, software and connected technologies.\nProvide expertise with object-oriented development methodologies, networks, data storage, data modeling, data ontologies, wireless communication and security architectures.\nCollaborate with mechanical, electrical and software engineers to evaluate technical alternatives, resolve integration challenges and establish effective engineering solutions.\nDefine interfaces that enable medical devices to communicate with external systems, including hospital networks and cloud-based platforms.\nServe as a principal technical resource, providing guidance on architectural decisions and resolving complex engineering challenges.\nPartner with engineering leadership and cross-functional teams to establish technical direction and gain alignment on design decisions.\nReview verification and validation strategies to ensure products meet system requirements, performance expectations and applicable regulatory standards.\nSupport risk management, design controls and technical documentation for regulatory submissions and audits.\nHands-on involvement in engineering activities throughout the product development lifecycle.\nProvide technical oversight and guide engineering personnel in resolving varied technical/scientific problems with systems engineering principles\nQualifications for the Principal System Engineer, Medical Devices\nBachelor's degree in Systems Engineering, Electrical Engineering, Mechanical Engineering, Biomedical Engineering or a related technical discipline.\nExtensive experience developing complex electromechanical systems, diagnostic equipment, or connected medical technologies within the medical device industry.\nStrong background in embedded software, firmware or software-intensive electromechanical systems.\nDemonstrated experience translating user needs into system requirements and developing system-level architectures.\nStrong understanding of hardware and software integration, system interfaces and technical requirements management.\nExperience leading complex engineering initiatives and influencing multidisciplinary teams without direct reporting authority.\nHands-on experience developing technical specifications, resolving system integration challenges and supporting product development.\nSolid understanding of verification and validation, risk management and regulated product development.\nExperience defining interfaces between physical devices and external systems, including hospital networks and cloud platforms.\nFamiliarity with APIs, interface control documents (ICDs) and wireless communication technologies.\nWorking knowledge of FDA design controls, ISO 13485, ISO 14971 and IEC 60601.\nExperience with model-based systems engineering (MBSE), SysML or related systems engineering tools.\nExperience developing medical devices for international markets.\nWhat we offer our Principal Systems Engineer, Medical Devices\nComprehensive benefits plan\n401K with match\nPension Plan\n16-week Paid Parental Leave\nGenerous PTO package, plus 14 paid holidays\nA great place to work!\nAt Medela, you will be joining a global community of colleagues, united by the purpose that drives our business: helping people. Medela exists to advance human health and well-being through knowledge-based and innovative human milk and medical vacuum solutions.\nThis is not a job description. More details will be provided regarding the functions of this position.\nAs an EEO/Affirmative Action Employer, all qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, citizenship, sex, protected veteran status, age, physical or mental disability, medical condition, HIV/AIDs status, marital status, domestic partner status, sexual orientation, gender identity (transgender status), weight, height or any other characteristic protected by federal, state, or local law or ordinance.\nhttps://mandatoryview.com/?LicenceId=e7c44cfe-6946-4b77-9939-493d186ba760&ProductType=OnlineApplicant&SubType=PG","description_format":"text","description_chars":5641,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["401k plan","Home office","Hybrid work","Parental leave"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Women’s Health & Maternity","Medical Supplies & Consumables"],"lifecycle":[{"event":"open","at":"2026-10-25T22:10:27Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 2","filings_12m":2,"filings_prev_12m":0,"green_card_filings_12m":0,"median_offered_wage_usd":202500,"route":null,"cap_exempt":false,"checked_at":"2026-10-29T16:27:21+00:00","sources":["US Department of Labor: LCA disclosure data (H-1B, H-1B1, E-3)"],"filings_for_role_12m":0}],"liveness":{"score":44,"band":"fade","label":"Fading","p_open":1,"p_active":0.791,"p_room":0.55,"age_days":36,"expected_fill_days":32,"reasons":["conf:5","win:tail"],"computed_at":"2026-11-03T05:54:40Z"},"pay":null,"html_url":"https://alion.io/job/medela-principal-systems-engineer","json_url":"https://alion.io/job/medela-principal-systems-engineer.json","meta":{"generated_at":"2026-11-04T05:02:13Z","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":7798,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-05T00:00:00Z"}},"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":1832456},"rest":"https://alion.io/mcp/rest/get_company?id=1832456"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fmedela-principal-systems-engineer"},{"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%2Fmedela-principal-systems-engineer"},{"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%2Fmedela-principal-systems-engineer"},{"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/medela-principal-systems-engineer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fmedela-principal-systems-engineer"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3251810}},{"tool":"search_jobs","arguments":{"company":"medela.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3251810},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. 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