{"id":3824232,"url":"https://alion.io/job/bracco-sr-design-assurance-engineer","title":"Sr. Design Assurance Engineer","company":{"id":1775320,"name":"Bracco","domain":"bracco.com","url":"https://alion.io/company/bracco","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"A","score":86,"open_postings":25,"ghost_share":0,"stale_share":0.56,"repost_share":0,"time_to_fill_p50_days":55,"computed_at":"2026-11-12T10:38:37Z"}},"role":"MedTech","role_family":"MedTech","seniority":"senior","employment_type":"full_time","work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Eden Prairie, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":112000,"max":120000,"currency":"USD","period":"year","gross":null,"usd_annual":120000},"salary_estimate":null,"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 820","optional":false},{"name":"Design Controls","optional":false},{"name":"FMEA","optional":false},{"name":"ISO 13485","optional":false},{"name":"ISO 14971","optional":false},{"name":"Verification & Validation","optional":false}],"status":"live","first_seen_at":"2026-11-05T17:58:01Z","employer_posted_date":"2026-11-05","last_verified_at":"2026-11-13T07:18:51Z","board_verified":true,"closed_at":null,"days_open":7,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":7},"description":"Why Join Bracco Medical Technologies?\nWe care as much about our employees as we do our patients. Our culture fosters a work environment where employees can thrive, be passionate and have fun along the way. Each member of the Bracco Medical Technologies team has the power to make a difference......everyday!\n-The Sr. Design Assurance Engineer position will support design assurance activities for Bracco Medical Technologies (BMT) products. This role is responsible for providing support for design verification and validation activities while ensuring compliance to BMT design control procedures and applicable regulations and external standards.This individual will provide hands-on, technical Quality Engineering support for new and existing products including development of quality requirements/plans for new products, design/process validation requirements, test method validation and ongoing change management for finished device manufacturing. The role works upstream and downstream ensuring the total product lifecycle is maintained and that our products continue to perform as designed.\nPrimary Duties & Responsibilities:\nDesign Assurance\nProvide direction and technical expertise to product development teams regarding quality characteristics and conformance to product requirements associated to medical devices or software as a medical device (SaMD) products.\nDrive the Design Control process and develop the Design and Development File (DDF) within the framework of regulatory requirements.\nEnsure that specifications and requirements are relevant, capable, contain essential elements and meet applicable standards, and that all requirements are suitably testable and verified.\nProvide guidance and support for design verification activities. Assess protocols and reports test robustness, traceability to requirements, and statistical sample sizes, and quality of the test spec.\nOwn risk management activities from planning, analysis and verification, and risk reporting and acceptance for the assigned areas of responsibility.\nProvide support for testing qualification, technical standards interpretation, and appropriate statistical methods, including sample size determination.\nGenerate the quality assurance deliverables to meet the project scope and plan.\nReview, provide input, and approve project-related deliverables and change orders.\nWork with external design/test organizations to ensure Design Control requirements are fulfilled and appropriate supplier controls are in place.\nDocuments and reports defects found during testing and works with the development team to ensure they are resolved.\nReview Design and Development Files and Technical Files for conformance to applicable requirements.\nPrepare technical sections of regulatory approval applications by identifying the testing needed to support global submission, and identifying U.S. and non U.S. product and safety standards.\nRigorous documentation for all phases of new product development including specifications, verification/validation test plans, and change orders associated with medical devices and consumable products.\nRoutine communication with peers and supervisors including documentation of work, meetings, and decisions. Maintain project plans, set/adhere to milestones, deliverables and budgets, and manage a limited number of concurrent projects.\nEnsure that all deliverables are clearly communicated to management including planning, deliverables and timing and defined objectives.\nQualifications (Knowledge, Skills & Abilities):\nMinimum\nB.S. in Computer Science, Engineering (electrical or mechanical), or comparable science discipline\nMinimum 5 years of Quality Engineering experience in medical device industry\nExtensive knowledge of and effective application of quality tools (e.g., Six Sigma, DOE, process analysis/capability, FMEA, FTA)\nExtensive knowledge with ISO 13485 quality system requirements and FDA quality system regulations 21CFR 820\nExtensive knowledge of risk management and ISO14971\nStrong written and verbal communication skills to effectively translate ideas, concepts and information\nAbility to develop clear, concise, and timely oral and written reports\nAbility to support critical projects that require advanced problem solving skills and project management oversight\nAbility to travel both domestically and internationally \nPreferred:\nAdvanced degree in Computer Science, Electrical Engineering, or Mechanical Engineering\nQuality Engineering experience with medical devices which incorporate software or products that are software as a medical device (SaMD)\nDemonstrated project management skills in order to plan, conduct and implement system assessments\nOther:\nTravel expected to be less than 10%.\nCompensation & Total Rewards:\nEstimated Starting Salary Range: $112,000 - 120,000\n*Estimated Starting Salary Range is reflective of the range Bracco Medical Technologies reasonably expects to pay for the position. The range provided is based on salary and market data specific to the position.\nTotal Rewards:\nPaid Time Off, Company Holidays & Paid Family Leave - We provide PTO and Company Holidays to help you recharge, relax and do what’s important to you, when it’s important to you. Our 100% paid family leave options for parents, grandparents and eligible family members provide support for growing families as well.\nAchieve - Beyond competitive compensation, we offer options to help you plan for a financially secure future, including an annual incentive plan and 401k savings plan contributions.\nLive well - We offer comprehensive benefit options to help protect you along the way, including medical, dental, vision, and life insurance, employer HSA contributions, employee assistance program, short-term disability, etc.\nEvolve - Through structured on-the-job learning, workshops, seminars, and our tuition reimbursement program, you’ll find many opportunities to grow, personally and professionally.\n Choose - You won’t find “stuffy” here-whether your position requires a hybrid or in-the-office working arrangement. That means business casual for your attire and flexibility in your schedule, wherever possible.\nBracco Medical Technologies is an Affirmative Action/Equal Opportunity Employer. Bracco Medical Technologies desires priority referrals of protected veterans for all openings.","description_format":"text","description_chars":6325,"description_truncated":false,"requirements":{"experience_years_min":5,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["401k plan","Life insurance","Parental leave"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Prescription Drugs","Medical Imaging Systems"],"lifecycle":[{"event":"open","at":"2026-11-05T17:58:01Z"}],"visa":[],"liveness":{"score":60,"band":"ok","label":"Likely open","p_open":1,"p_active":0.602,"p_room":1,"age_days":6,"expected_fill_days":55,"reasons":["conf:4","stale_co","win:early","comp:brand"],"computed_at":"2026-11-12T10:38:37Z"},"pay":{"stated_usd_annual":120000,"is_top_pay":false},"html_url":"https://alion.io/job/bracco-sr-design-assurance-engineer","json_url":"https://alion.io/job/bracco-sr-design-assurance-engineer.json","meta":{"generated_at":"2026-11-13T08:11:28Z","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":16958,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-14T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.1,"usd":0.01,"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":1775320},"rest":"https://alion.io/mcp/rest/get_company?id=1775320"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fbracco-sr-design-assurance-engineer"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"free","price":{"credits":0,"usd":0},"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%2Fbracco-sr-design-assurance-engineer"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.1,"usd":0.01},"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%2Fbracco-sr-design-assurance-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/bracco-sr-design-assurance-engineer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fbracco-sr-design-assurance-engineer"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3824232}},{"tool":"search_jobs","arguments":{"company":"bracco.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3824232},"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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