{"id":2529732,"url":"https://alion.io/job/philips-senior-design-quality-engineer","title":"Senior Design Quality Engineer","company":{"id":13838,"name":"Philips","domain":"philips.com","url":"https://alion.io/company/philips-2","size_band":"501-1000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","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":"CAPA","optional":false}],"status":"live","first_seen_at":"2026-10-13T00:00:00Z","employer_posted_date":"2026-10-13","last_verified_at":"2026-10-15T21:59:21Z","board_verified":true,"closed_at":null,"days_open":3,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":3},"description":"Job Title\nSenior Design Quality EngineerJob Description\nThe Senior Design Quality Engineer is responsible for the entire design control process, from validating design inputs to overseeing verification, validation, and design transfer, as well as leading comprehensive process validation strategies to ensure new products and current portfolio meet quality and regulatory standards during production.\nYour role:\nPlan and execute comprehensive process validation strategies using statistical tools to ensure seamless transition of new products to production, meeting quality and regulatory standards.\nLeads the entire design control process, from eliciting and validating design inputs to managing verification, validation, and smooth design transfer, ensuring rigorous adherence to regulatory and quality standards. Leads quality improvement projects by integrating quality, reliability, and Post Market Surveillance (PMS) insights into all stages of the product lifecycle, driving continuous enhancement of product quality and reliability.\nDrafts and upholds detailed quality engineering documents, including quality plans for hardware, software, and systems, ensuring all documentation is accurate, up-to-date, and compliant with regulatory requirements.\nConducts thorough assessments of product and system designs, reviews performance data, and performs root cause analysis to identify and address quality deficiencies, ensuring the highest standards of design excellence.\nValidates critical design inputs such as usability, reliability, performance, manufacturability, and safety, ensuring alignment with both quality standards and regulatory requirements.\nGuides comprehensive risk management activities throughout the product lifecycle, ensuring potential risks are accurately identified, assessed, and effectively mitigated to uphold product safety and quality.\nLeverages post-market performance data to assess product effectiveness in the field, providing actionable feedback to manufacturing and design teams, and initiating corrective actions when necessary.\nEnsures preparation for quality audits and inspections, maintaining all necessary documentation and processes to demonstrate compliance with both internal and external quality standards.\nRecords, manages, and executes CAPA processes, including problem identification, root cause analysis, and implementation of solutions to prevent recurrence and drive continuous improvement.\nApply continuous improvement techniques to enhance quality practices, ensuring ongoing audit readiness and strict adherence to both internal and external quality standards throughout the product lifecycle.\nBuilds and nurtures effective relationships with internal and external stakeholders, providing expert guidance and mentorship to cross-functional teams, ensuring alignment with quality standards and successful project milestones.\nContributes to the development, implementation, and revision of QMS processes, including standard operating procedures (SOPs), work instructions, and quality manuals, ensuring their accuracy, clarity, and compliance with relevant standards.\nPrevious experience documenting design, process and/or QMS changes and executing applicable gap assessments.\nYou're the right fit if:\nYou have a minimum of 5+ years’ experience in FDA regulated medical device environments, with a focus on Design Assurance/Control, detailed knowledge of Risk Management (ISO 14971), and strong Understanding of all aspects of the QMS related to Design Controls.\nYou have proven experience in Design Verification/Validation, Root Cause analysis and Defect Management.\nYou have detailed experience in identifying, promoting, and supporting processes and design quality tools for use in tracking/preventing product defects, design traceability, and Design for Reliability.\nYou have extensive experience in CAPA processes, including problem identification, root cause analysis, implementation of solutions to prevent recurrence and drive continuous improvement.\nYou’re experienced in utilizing Quality, Reliability and Post Market Surveillance (PMS) insights/data analytics to lead continuous improvement throughout all stages of the product lifecycle.\nYou’re able to share knowledge, insights regarding quality standards, and regulatory requirements.\nYou have a minimum of a Bachelor’s Degree (Required), in Quality, Engineering or similar disciplines. ASQ-CQE, ISO 13485 training, ISO Lead Auditor 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 an Office role.\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":7124,"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":"2026-10-14T12:35:12Z"}],"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":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":2,"expected_fill_days":38,"reasons":["conf:2","win:early","comp:brand"],"computed_at":"2026-10-15T05:46:00Z"},"pay":{"stated_usd_annual":163968,"is_top_pay":true},"html_url":"https://alion.io/job/philips-senior-design-quality-engineer","json_url":"https://alion.io/job/philips-senior-design-quality-engineer.json","meta":{"generated_at":"2026-10-16T00:31:15Z","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":964,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-17T00:00:00Z"}},"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-senior-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-senior-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-senior-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-senior-design-quality-engineer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fphilips-senior-design-quality-engineer"}]}