{"id":3369750,"url":"https://alion.io/job/abbvie-principal-systems-engineer-rd-device-combination-product-development","title":"Principal Systems Engineer, R&D Device & Combination Product Development","company":{"id":3660,"name":"AbbVie","domain":"abbvie.com","url":"https://alion.io/company/abbvie","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"SmartRecruiters","truth_index":{"grade":"B","score":80,"open_postings":70,"ghost_share":0,"stale_share":1,"repost_share":0,"time_to_fill_p50_days":16,"computed_at":"2026-11-01T06:10:25Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"lead","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Chicago, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":124500,"max":236500,"currency":"USD","period":"year","gross":null,"usd_annual":236500},"salary_estimate":null,"experience_years_min":14,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 820","optional":false},{"name":"Design Controls","optional":false},{"name":"Design History File","optional":false},{"name":"EU MDR","optional":false},{"name":"IEC 60601","optional":false},{"name":"IEC 62304","optional":false},{"name":"IEC 62366","optional":false},{"name":"ISO 13485","optional":false},{"name":"ISO 14971","optional":false}],"status":"live","first_seen_at":"2026-10-27T21:15:59Z","employer_posted_date":"2026-10-27","last_verified_at":"2026-11-01T22:30:49Z","board_verified":true,"closed_at":null,"days_open":5,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":5},"description":"About AbbVie\nAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.\n AbbVie is seeking a Principal Systems Engineer to serve as a technical leader within R&D Device and Combination Product Development (DCPD), providing expertise in Systems Engineering, Compliance, Design Controls, and Risk Management. This individual will contribute to the development of innovative therapeutic drug-device combination products and aesthetic devices with technologies ranging from prefilled syringes and autoinjectors to connected and electromechanical drug delivery systems to eyecare products to breast implants.\nThis role will work in a global, cross functional team with the responsibility for the integration of inputs and risks from multiple disciplines to ensure robust patient-centric product design and performance. Technical expertise and leadership will be required to ensure that development activities align with both business objectives and global regulatory requirements while enabling efficient market access across worldwide regions.\nResponsibilities:\nThis role will include implementation of product development engineering principles within the Design Controls process, with particular focus on Design Inputs, Risk Management, compliance governance, and systems integration. This role requires establishing strong working relationships across North America and Europe and may involve periodic travel.\nThis role will be responsible for driving the following activities and deliverables:\nUser and Stakeholder Needs Definition\nSystem Requirements Definition\nRisk Management Planning and reporting in accordance with ISO 14971\nSystem Risk Assessment\nUse Error Risk Assessments\nDesign Control Traceability\nAdditionally, this role will:\nTranslate evolving global regulations, standards, and guidance documents into practical Design Control and Risk Management processes that support efficient product development and enable global market access.\nDevelop and maintain compliance strategies that support product registration and commercialization in global markets.\nEvaluate regulatory trends and emerging industry expectations to proactively strengthen Design Control and Risk Management practices.\nLead integration of Third-Party Development and Drug Product Development activities\nServe as a subject matter expert during interactions with certification agencies and regulatory authorities.\nFacilitate decision-making across diverse technical and business stakeholders while balancing compliance, innovation, timelines, and business objectives.\nAt this level, significant contribution to raising the bar on how AbbVie develops combination products is expected. This includes:\nIdentifying opportunities to generate innovative improvements in Design Control and Risk Management processes.\nLeading strategic initiatives focused on improving development efficiency, compliance effectiveness, and product quality.\nDriving organizational capability development through training, knowledge-sharing, coaching and mentoring.\nFoster a culture of continuous improvement, innovation, and technical excellence.\nPromote harmonized global approaches to compliance and systems engineering practices.\n BS in Engineering, Science, or related discipline with 14+ years of experience; OR MS in Engineering, Science, or related discipline with 12+ years of experience; OR PhD in Engineering, Science, or related discipline with 6+ years of experience.\nDemonstrated ability to resolve complex technical and compliance challenges through expert application of engineering principles and regulatory knowledge.\nExpertise in medical device and/or combination product development including strong knowledge of FDA 21 CFR Part 820, ISO 14971, ISO 13485, and EU MDR.\nExpertise in Systems Engineering principles, including:User and Stakeholder Needs definition\nRequirements development\nTraceability\nChange management\nRisk management\n\nExpertise in DHF development, maintenance, and governance.\nExperience supporting internal audits, external audits, certification body assessments, and regulatory inspections.\nExperience translating complex regulatory requirements and industry standards into operational development processes.\nStrong analytical, decision-making, and communication skills.\nDemonstrated ability to influence without direct authority across cross-functional organizations.\nExperience leading technical initiatives involving external partners and suppliers.\nStrong written communication skills, including development of technical documentation and compliance deliverables.\nAbility to effectively operate within global and multicultural environments.\nActive participation in AAMI, IEC Technical Committees, ISO Working Groups, AdvaMed, or similar industry organizations.\nExperience supporting global product registrations and regulatory submissions.\nExperience developing compliance governance frameworks, metrics, and performance indicators.\nExperience leading enterprise-wide Compliance, Design Control, or Risk Management improvement initiatives.\nDemonstrated success developing training programs and communities of practice.\nFamiliarity with electromechanical, connected, and software-enabled medical devices.\nKnowledge of IEC 62366, IEC 62304, IEC 60601. Travel\n\nTravel required, as necessary (approximately 10%).\n Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:\nThe compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. \nWe offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.\nThis job is eligible to participate in our long-term incentive programs. \nNote: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.\nAbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.\nUS & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html\nUS & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:\nhttps://www.abbvie.com/join-us/reasonable-accommodations.html","description_format":"text","description_chars":7479,"description_truncated":false,"requirements":{"experience_years_min":14,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[{"language":"English","level":"All levels","optional":false}]},"benefits":["Vision insurance"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Prescription Drugs","Oncology Therapeutics","Neurology & CNS Therapeutics","Immunology & Inflammation Therapeutics"],"lifecycle":[{"event":"open","at":"2026-10-28T00:28:44Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 236 · green card filings: 57","filings_12m":236,"filings_prev_12m":256,"green_card_filings_12m":57,"median_offered_wage_usd":150555,"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)","US Department of Labor: PERM disclosure data (green cards)"],"filings_for_role_12m":0}],"liveness":{"score":63,"band":"ok","label":"Likely open","p_open":1,"p_active":0.627,"p_room":1,"age_days":4,"expected_fill_days":16,"reasons":["conf:3","stale_co","velocity","win:early","comp:brand"],"computed_at":"2026-11-01T06:10:25Z"},"pay":{"stated_usd_annual":236500,"is_top_pay":true},"html_url":"https://alion.io/job/abbvie-principal-systems-engineer-rd-device-combination-product-development","json_url":"https://alion.io/job/abbvie-principal-systems-engineer-rd-device-combination-product-development.json","meta":{"generated_at":"2026-11-02T01:13:35Z","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":1849,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-03T00:00:00Z"}},"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":3660},"rest":"https://alion.io/mcp/rest/get_company?id=3660"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fabbvie-principal-systems-engineer-rd-device-combination-product-development"},{"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%2Fabbvie-principal-systems-engineer-rd-device-combination-product-development"},{"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%2Fabbvie-principal-systems-engineer-rd-device-combination-product-development"},{"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/abbvie-principal-systems-engineer-rd-device-combination-product-development\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fabbvie-principal-systems-engineer-rd-device-combination-product-development"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3369750}},{"tool":"search_jobs","arguments":{"company":"abbvie.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3369750},"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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