{"id":3056670,"url":"https://alion.io/job/philips-software-design-quality-engineer","title":"Software Design Quality Engineer","company":{"id":13838,"name":"Philips","domain":"philips.com","url":"https://alion.io/company/philips-2","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":80,"open_postings":65,"ghost_share":0,"stale_share":0.985,"repost_share":0,"time_to_fill_p50_days":9,"computed_at":"2026-10-24T06:02:35Z"}},"role":"QA","role_family":"QA","seniority":"senior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Bedford, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":102480,"max":163968,"currency":"USD","period":"year","gross":null,"usd_annual":163968},"salary_estimate":null,"experience_years_min":5,"visa_sponsorship":true,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Agile","optional":false},{"name":"C#","optional":false},{"name":"C++","optional":false},{"name":"Design Controls","optional":false},{"name":"IEC 62304","optional":false},{"name":"ISO 14971","optional":false},{"name":"Verification & Validation","optional":false}],"status":"live","first_seen_at":"2026-09-18T00:00:00Z","employer_posted_date":"2026-09-18","last_verified_at":"2026-10-24T06:59:20Z","board_verified":true,"closed_at":null,"days_open":36,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":36},"description":"Job Title\nSoftware Design Quality EngineerJob Description\nThe Software Design Quality Engineer is responsible for developing, maintaining, and managing comprehensive software quality documentation, ensuring their accuracy and regulatory compliance throughout the software lifecycle.\nYour role:\nLeads the assessment of software designs by reviewing test and performance data to uphold quality, safety, and regulatory standards, and address any engineering deficiencies.\nLead in the effective application, compliance, and continuous improvement of policies, procedures, and practices related to software development and validation including- Software design/verification, Risk management, Systems validation, Traceability and Cyber security risk management.\nTrack and risk assess software Anomalies for pre- and post-market medical device software.\nConducts detailed root cause analyses for software quality issues and validating key design inputs like usability, reliability, and performance.\nAssess products and systems to identify defects, abnormalities and design flaws by authoring and executing software test protocols and generating test reports.\nImplements software quality plans and risk management activities, utilizes post-market analytics to monitor software performance, and initiates corrective actions as needed.\nEnsure compliance across the product software lifecycle by overseeing regulatory planning and execution for new products and changes as well as managing filings and approvals by overseeing preparation and submission of documentation for global registrations to enable timely market access.\nDrive regulatory excellence and continuous improvement by developing plans, assessing risks, implementing actions, and optimizing regulatory processes for efficiency while maintaining high compliance standards.\nYou're the right fit if:\nYou have a minimum of 5+ years’ experience in FDA regulated, IEC 62304 medical device software environments, with a focus on Software Design Assurance/Control, detailed knowledge of Risk Management (ISO 14971), SDLC and strong Understanding of all aspects of the QMS related to Software Design Controls.\nYou have proven experience in Root Cause Analysis, Software V&V, identifying/ supporting processes and design quality tools for use in tracking/preventing software defects, design traceability, Design for Quality (DfQ), Agile, and SAFe.\nStrong experience with complex medical systems containing software, hardware and disposables.\nYou’re able to share knowledge, insights regarding software quality standards, and regulatory requirements.\nYou have excellent written and verbal communication skills, with the ability to communicate and present to all levels of management.\nAbility to interpret software design and code (C/C++/C# or any other object-oriented language) to verify implementation of requirements.\nYou have a minimum of a Bachelor’s Degree (Required), in Quality, Computer Science/Engineering or similar disciplines. ISTQB certification desired.\nYou must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position. \nHow we work together:\nWe believe that we are better together than a part. For our Office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time (5 days per week) presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations. This is anOffice-basedrole.\nAbout Philips:\nWe are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality. healthcare that we all deserve. Do the work of your life to help improve the lives of others.\nLearn more about our business.\nDiscover our rich and exciting history.\nLearn more about our purpose.\nLearn more about our culture.\nPhilips Transparency Details:\nThe pay range for this position in Bedford, MA is $102,480 to $163,968.\nThe actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.\nAt Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.\nIn addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here.\nAdditional Information:\nUS work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.\nCompany relocation benefits WILL NOT be provided for this position. For this position, you must reside in or within commuting distance to Bedford, MA.\nMay require travel up to 10%.\n#LI-PH1\nThis requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.\nPhilips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.","description_format":"text","description_chars":5668,"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","Equity"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":true,"industries":["Health & Medical Electronics","Respiratory & Sleep Devices","Patient Monitoring","EHR & Clinical Software"],"lifecycle":[{"event":"open","at":"2026-10-22T04:04:48Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 29 · green card filings: 19","filings_12m":29,"filings_prev_12m":54,"green_card_filings_12m":19,"median_offered_wage_usd":128438,"route":null,"cap_exempt":false,"checked_at":"2026-10-15T11:24:14+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":11,"band":"cold","label":"Long shot","p_open":1,"p_active":0.312,"p_room":0.35,"age_days":36,"expected_fill_days":9,"reasons":["conf:3","stale_co","velocity","win:tail","comp:brand"],"computed_at":"2026-10-24T06:02:35Z"},"pay":{"stated_usd_annual":163968,"is_top_pay":true},"html_url":"https://alion.io/job/philips-software-design-quality-engineer","json_url":"https://alion.io/job/philips-software-design-quality-engineer.json","meta":{"generated_at":"2026-10-24T11:37:02Z","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":16570,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-25T00:00:00Z"}},"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":13838},"rest":"https://alion.io/mcp/rest/get_company?id=13838"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fphilips-software-design-quality-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%2Fphilips-software-design-quality-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%2Fphilips-software-design-quality-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/philips-software-design-quality-engineer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fphilips-software-design-quality-engineer"}]}