{"id":3286476,"url":"https://alion.io/job/werfen-senior-systems-engineer","title":"Senior Systems Engineer","company":{"id":1839823,"name":"Werfen","domain":"werfen.com","url":"https://alion.io/company/werfen","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"iCIMS","truth_index":null},"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":"explicit","locations":["Bedford, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":110000,"max":140000,"currency":"USD","period":"year","gross":null,"usd_annual":140000},"salary_estimate":null,"experience_years_min":4,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Error Budget","optional":false},{"name":"FMEA","optional":false},{"name":"GMP","optional":false},{"name":"IEC 62304","optional":false},{"name":"IEC 62366","optional":false},{"name":"ISO 14971","optional":false},{"name":"Python","optional":false},{"name":"SLI/SLO/SLA","optional":false},{"name":"Verification & Validation","optional":false}],"status":"live","first_seen_at":"2026-10-26T18:35:30Z","employer_posted_date":"2026-10-26","last_verified_at":"2026-10-27T12:50:14Z","board_verified":true,"closed_at":null,"days_open":0,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":0},"description":"Introduction\nWerfen\nWerfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.\nOur success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.\nOverview\nPosition Summary:\nThe Senior Systems Engineer supports system integration, verification, validation, defect analysis, and remediation activities throughout product development. This role is responsible for translating user needs and system requirements into system-level verification and validation test cases, executing and documenting testing activities, supporting product risk management, and ensuring compliance with applicable regulatory requirements and standards. The engineer collaborates with cross-functional teams to analyze test results, identify issues and risks, support issue resolution, and verify the implementation and effectiveness of risk controls.\nThe annual base salary range for this role is currently $110,000 to $140,000. Individual employee compensation will ultimately depend on factors including education, relevant experience, skillset, knowledge, and particular business needs.\nThis role is eligible for medical, dental, and vision insurance, 401k plan retirement benefits with an employer match, as well as paid vacation and sick leave.\nResponsibilities\nKey Accountabilities\nEssential Functions:\nOwns system-level defect analysis and remediation during System Integration, Verification, and Validation phases.\nSupports Product Risk Management activities, regulatory and standards compliance, and country approval efforts.\nConducts risk analyses, including Design Failure Mode and Effects Analysis (DFMEA), and supports the development of risk control measures.\nTranslates user needs and system requirements into system-level verification and validation test cases with appropriate traceability.\nExecutes and documents system integration, verification, and validation testing involving hardware, software, subsystems, and external interfaces.\nAnalyzes test results, identifies issues and risks, and collaborates with cross-functional teams to support timely resolution.\nParticipates in system test, technical, and design reviews with a focus on verification coverage, defects, and readiness milestones.\nSupports Product Safety Risk Management activities by verifying implementation and effectiveness of assigned risk controls in a regulation-compliant manner.\nApplies standard test practices, tools, and templates and contributes to continuous improvement of system test processes.\nConducts cascade analysis and error budget allocation\nEffectively communicates complex technical information to a cross-functional team in the form of documentation, presentations or technical summaries.\nIndependently generates predictable schedules for activities related to assigned projects.\nSkills & Capabilities:\nThe ideal candidate for this position will exhibit the following skills and capabilities:\nKnowledge of medical device standards and regulations, including ISO 14971, IEC 62304, IEC 62366, and FDA GMP/QSR, and their impact on verification and validation activities.\nExperience executing system-level or integration test activities for complex products.\nAbility to analyze test results and identify issues and risks.\nAbility to support risk management activities, including DFMEA and risk control verification.\nEffective collaboration and communication skills within cross-functional teams.\nExperience with requirements management, digital traceability tools, and test automation preferred.\nExperience working with electromechanical and/or mechatronic systems.\nKnowledge of system integration principles and system-level testing methodologies.\nUnderstanding of embedded software design, implementation, integration, and test activities.\nExperience with control systems; stepper motor control experience preferred.\nAbility to diagnose and troubleshoot system performance issues using equipment, schematics, and algorithm analysis.\nProgramming experience, preferably Python.\nExperience using test and measurement equipment, including oscilloscopes, digital multimeters (DMMs), and logic analyzers.\nQualifications\nMinimum Knowledge & Experience Required for the Position:\nEducation:\nBachelor's degree in Engineering, Science or a related field\nExperience:\nEight years of product development or relevant experience\nFour to six years of product development or relevant experience for advanced degrees\nFor internal candidate promotion: Demonstrated proficiency in meeting all competencies of current level and acceptable performance history may be used in lieu of experience\nIn vitro medical device experience highly desired.\nAdditional Skills/Knowledge:\nLanguage: Proficiency in English language required\nInternational Mobility:\nRequired: No\nTravel R equirements:\nSome domestic and international travel may be required.\nClosing\nIf you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.\nWerfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact  for assistance.\nWe operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team.\nwww.werfen.com","description_format":"text","description_chars":6561,"description_truncated":false,"requirements":{"experience_years_min":4,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[{"language":"English","level":"Advanced (C1)","optional":false}]},"benefits":["401k plan","Vision insurance"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Diagnostic Tests & IVD","Medical Supplies & Consumables"],"lifecycle":[{"event":"open","at":"2026-10-26T18:35:30Z"}],"visa":[],"liveness":{"score":90,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.903,"p_room":1,"age_days":0,"expected_fill_days":10,"reasons":["conf:1","velocity","win:early"],"computed_at":"2026-10-27T05:46:45Z"},"pay":{"stated_usd_annual":140000,"is_top_pay":true},"html_url":"https://alion.io/job/werfen-senior-systems-engineer","json_url":"https://alion.io/job/werfen-senior-systems-engineer.json","meta":{"generated_at":"2026-10-27T13:12:22Z","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":1188,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-28T00:00:00Z"}},"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":1839823},"rest":"https://alion.io/mcp/rest/get_company?id=1839823"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fwerfen-senior-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%2Fwerfen-senior-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%2Fwerfen-senior-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/werfen-senior-systems-engineer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fwerfen-senior-systems-engineer"}]}