{"id":3286475,"url":"https://alion.io/job/werfen-senior-lead-systems-engineer","title":"Senior Lead 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":"lead","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":160000,"max":190000,"currency":"USD","period":"year","gross":null,"usd_annual":190000},"salary_estimate":null,"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Design Controls","optional":false},{"name":"Verification & Validation","optional":false},{"name":"Agile","optional":true},{"name":"IBM DOORS","optional":true},{"name":"IEC 60601","optional":true},{"name":"ISO 13485","optional":true},{"name":"ISO 14971","optional":true}],"status":"live","first_seen_at":"2026-10-26T18:35:30Z","employer_posted_date":"2026-10-26","last_verified_at":"2026-10-28T17:05:51Z","board_verified":true,"closed_at":null,"days_open":2,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":2},"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 Engineering Group Lead will have a player-coach technical authority for Class II and Class III coagulation programs - you will own design controls, product reliability, and a five-person systems engineering team.\nThis role will assign and oversee the practical application of technology across multiple programs, leading requirements management, risk management, verification and validation, and traceability from design input through design output. You will set system integration and V&V strategy, build the plans, protocols, and validation documentation that stand up to FDA scrutiny, and drive execution with Mechanical, Electrical, Software, Quality, Regulatory, and Project Management. This is a hands-on leadership role: you develop the team, make the technical calls, and still contribute directly on the programs that matter most.\nThe annual base salary range for this role is currently $160,000 to $190,000. This is a bonus-eligible position. 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:\nLead design inputs and design outputs for Class II and Class III medical devices, including Requirements Management, Risk Management, Verification & Validation (V&V), and Traceability.\nOwn product reliability strategy and execution across the product lifecycle.\nLead system integration, verification, and validation strategies.\nDevelop development plans, protocols, and validation documentation.\nCollaborate across Mechanical, Electrical, Software, Quality, Regulatory, and Project Management teams.\nDrive technical decisions, project execution, and team development.\nServe in a player-manager capacity, directly leading and developing a five-member systems engineering team while contributing technically to key programs.\nServe as a technical authority for coagulation programs and system architecture.\nSkills & Capabilities:\nDemonstrated leadership of requirement management, risk management, system integration, verification, and validation activities. \nStrong understanding of FDA regulations, quality systems, and product development lifecycles.\nExpertise in Waterfall and Agile methodologies. \nExperience with requirements management, risk management, and V&V methodologies. \nMedical device design controls knowledge (ISO 13485, ISO 14971, IEC 60601). \nFamiliarity with JAMA, DOORS, or similar requirements tools. \nExcellent communication, mentorship, prioritization, and problem-solving skills. \nQualifications\nMinimum Knowledge & Experience Required for the Position:\nBachelor's degree in Electrical, Systems, Biomedical Engineering, or related discipline. \n15 years of relevant engineering experience; 10 years with advanced degree.\nExperience with FDA-regulated Class II and/or Class III medical devices.\nInternational Mobility: Required:\nNo\nTravel requirements:\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":5052,"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","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":1,"expected_fill_days":10,"reasons":["conf:2","velocity","win:early"],"computed_at":"2026-10-28T05:59:10Z"},"pay":{"stated_usd_annual":190000,"is_top_pay":true},"html_url":"https://alion.io/job/werfen-senior-lead-systems-engineer","json_url":"https://alion.io/job/werfen-senior-lead-systems-engineer.json","meta":{"generated_at":"2026-10-28T18:44:07Z","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":25556,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-29T00:00:00Z"}},"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-lead-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-lead-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-lead-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-lead-systems-engineer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fwerfen-senior-lead-systems-engineer"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3286475}},{"tool":"search_jobs","arguments":{"company":"werfen.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3286475},"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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