{"id":3167993,"url":"https://alion.io/job/werfen-director-of-systems-engineering","title":"Director of Systems Engineering","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":"Leadership","role_family":"Leadership","seniority":"head","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"explicit","locations":["Norcross, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":151000,"max_usd":283000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":2716},"experience_years_min":15,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Design Controls","optional":false},{"name":"EU MDR","optional":false},{"name":"GMP","optional":false}],"status":"live","first_seen_at":"2026-10-23T17:50:00Z","employer_posted_date":"2026-10-23","last_verified_at":"2026-11-03T11:36:43Z","board_verified":true,"closed_at":null,"days_open":10,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":10},"description":"Introduction\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\nJob Summary\nThe Director of Systems Engineering provides strategic and technical leadership for the Systems Engineering function, leading the development and integration of on market and new product medical device systems from concept through commercialization. This role builds organizational capability, drives systems engineering excellence, and ensures customer, business, technical, and regulatory requirements are translated into innovative and marketable products.\nResponsibilities\nKey Accountabilities\nProvide strategic leadership and direction for a multidisciplinary team of scientists and technologists, fostering a high-performance culture, organizational alignment, and strong talent development pipeline.\nBuild a strong team and create a culture of accountability, ownership, integrity, and innovation\nEstablish and maintain governance frameworks to ensure compliance with all organizational policies, quality systems, regulatory requirements, and industry standards applicable to R&D activities.\nLead functional strategy and capability development, ensuring alignment with business objectives while driving execution of organizational priorities and long-term innovation goals.\nChampion scientific excellence by developing organizational capabilities, promoting advanced scientific and statistical methodologies, and ensuring adoption of industry best practices across teams.\nOversee the review and approval of design and development documentation, ensuring technical rigor, regulatory compliance, and alignment with quality and business objectives.\nDirect and manage strategic relationships with external development partners, ensuring alignment on scope, deliverables, timelines, and investments while proactively addressing risks and changes.\nProvide executive oversight for project and product risk management activities, ensuring timely identification, assessment, mitigation, and escalation of key technical and business risks.\nLeverage deep expertise in mechanical systems, fluidics, electronics, and medical device technologies to guide technical strategy, innovation, and decision-making across development programs.\nServe as a key stakeholder in portfolio planning and governance, providing strategic direction for design and development activities to ensure successful execution of project objectives.\nDrive the development of innovative testing capabilities, infrastructure, and methodologies that support product characterization, verification, validation, and commercialization efforts.\nProvide leadership in evaluating technology feasibility, product performance, and system capabilities to support investment decisions, product strategy, and development roadmaps.\nChampion data-driven decision-making by ensuring robust experimental design, statistical analysis, and interpretation of results across development programs to accelerate product innovation and continuous improvement.\nPerform other duties and responsibilities as assignedReasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.\nNetworking/Key relationships\nR&D, R&D Reagent & Assay Development, Marketing, Operations, QA/RA\nPMO\nExternal development partners\nTransfusion Leadership Team \nQualifications\nMinimum Knowledge & Experience required for the position:\nBachelor’s degree in engineering required; advanced degree (M.S. or Ph.D.) in Engineering, Systems Engineering, Biomedical Engineering, or related discipline strongly preferred.\nMinimum of 15 years of progressive engineering experience, including at least 12 years within the medical device industry and demonstrated success leading complex systems development organizations and cross-functional product development programs.\nProven ability to communicate complex technical concepts, system-level tradeoffs, and strategic recommendations to executive leadership, cross-functional stakeholders, and external partners.\nExceptional analytical, critical thinking, and problem-solving skills, with demonstrated expertise in systems engineering principles, product development processes, and technical decision-making across complex product portfolios.\nExtensive experience leading the development of complex medical device systems, including hardware, software, automation, fluidics, electronics, and integrated system solutions.\nDeep knowledge of medical device regulations and quality systems, including FDA requirements, ISO standards, GMP guidelines, design controls, and product lifecycle management processes.\nDemonstrated success leading multiple programs and engineering resources simultaneously, with strong portfolio management, prioritization, and organizational leadership skills.\nExperience driving Design for Six Sigma (DFSS), systems thinking, and quality-by-design methodologies to ensure robust product development and successful commercialization outcomes.\nExpertise in translating customer, clinical, business, and regulatory needs into system requirements, architectures, and product strategies.\nDemonstrated experience leading systems architecture, requirements management, system modeling, simulation, verification, and validation activities across the product development lifecycle.\nStrong knowledge of design transfer processes and cross-functional integration to ensure successful transition from development through manufacturing, launch, and sustainment.\nRecognized expertise in systems-level risk management, including development and execution of risk assessment, mitigation, and decision-making processes in compliance with applicable standards and regulations.\nExperience defining and executing systems engineering strategies, processes, tools, and organizational capabilities that support innovation and business growth.\nDemonstrated ability to influence technology roadmaps, product portfolio decisions, and long-term engineering investments through strategic leadership and technical vision.\nExperience building, developing, and leading high-performing systems engineering teams, including talent development, succession planning, and organizational capability enhancement.\nManagement has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.\nSkills & Capabilities:\nStrong understanding of regulatory requirements \nStrong understanding of development of IVD automated testing systems \nStrong understanding of design control processes including requirements development and risk management.\nStrong leadership skills with capability to attract and develop talent\nTravel requirements:\nUp to 15%\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":8525,"description_truncated":false,"requirements":{"experience_years_min":15,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":true},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Industrial Engineering","Diagnostic Tests & IVD","Medical Supplies & Consumables"],"lifecycle":[{"event":"open","at":"2026-10-23T17:50:00Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 1","filings_12m":1,"filings_prev_12m":0,"green_card_filings_12m":0,"median_offered_wage_usd":82500,"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":65,"band":"ok","label":"Likely open","p_open":1,"p_active":0.867,"p_room":0.75,"age_days":10,"expected_fill_days":12,"reasons":["conf:3","velocity","win:late"],"computed_at":"2026-11-03T05:54:40Z"},"pay":null,"html_url":"https://alion.io/job/werfen-director-of-systems-engineering","json_url":"https://alion.io/job/werfen-director-of-systems-engineering.json","meta":{"generated_at":"2026-11-03T13:19:56Z","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":18393,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-04T00:00:00Z"}},"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-director-of-systems-engineering"},{"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-director-of-systems-engineering"},{"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-director-of-systems-engineering"},{"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-director-of-systems-engineering\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fwerfen-director-of-systems-engineering"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3167993}},{"tool":"search_jobs","arguments":{"company":"werfen.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3167993},"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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