{"id":1453595,"url":"https://alion.io/job/conmed-design-quality-engineer","title":"Design Quality Engineer","company":{"id":1896673,"name":"CONMED","domain":"conmed.com","url":"https://alion.io/company/conmed-com","size_band":"51-200","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Schema","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"junior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Denver, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":74200,"max":94600,"currency":"USD","period":"year","gross":null,"usd_annual":94600},"salary_estimate":null,"experience_years_min":2,"visa_sponsorship":true,"relocation_package":false,"has_equity":true,"technologies":[],"status":"live","first_seen_at":"2026-09-24T00:00:00Z","employer_posted_date":"2026-09-24","last_verified_at":"2026-10-12T23:01:37Z","board_verified":true,"closed_at":null,"days_open":19,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":19},"description":"The Design Quality Engineer is responsible for supporting all quality engineering activities to support the new product life cycle, from concept to commercialization, and sustaining activities. The Design Quality Engineer will serve as the quality engineering contact and be a key member of the cross-functional development and sustaining teams. The Design Quality Engineer serves as the key resource for ensuring compliance to ISO, EU MDR, and FDA QSR requirements for Medical Devices. The Design Quality Engineer takes the lead with quality initiatives with inter-organizational impact following QSR, CONMED Policies, standards and regulations. Works under direction from Quality Management.\nKey Duties and Responsibilities\nSupports and provides direction to product development teams for the required quality deliverables.\nEnsures that product design meets customer expectations, regulatory requirements, appropriate voluntary standards, and all corporate requirements. Shows focus toward continuous improvement.\nReview, assess, and approve product design documentation to ensure compliance throughout product development cycle. Review and approve engineering designs/changes for adequate quality, reliability, maintainability, risk management, modeling, systems design, assessment tools, reporting, and manufacturability.\nTroubleshoot and direct the resolution of quality issues by fostering effective interdepartmental and cross-functional partnerships.\nA relentless focus on the safety and the efficacy of the medical device.\nReview and approve engineering designs/changes for adequate quality, reliability, maintainability, risk management, modeling, systems design, assessment tools, reporting, and manufacturability.\nReview and approve design verification and design validation protocols and reports. Ensure design activities prove design inputs and user needs are adequately addressed.\nLeads and provides support on risk management activities with a focus on clinician and patient safety.\nSupport product development through capability assessment, analyzing performance data, facilitating problem-solving activities, developing quality tools, and quality techniques.\nSupport sustaining activities such as complaint investigation and complaint trending. Monitor and analyze manufacturing and service trends. Perform Predicate Device reviews and surveillance reports. Able to perform data mining, analyze data and create trend reports.\nDemonstrate quality assertiveness and be able to represent the Quality function in various roles such as product support and lifecycle management.\nInvestigates process and product issues identified through complaints and trend analysis of other conformance data. Works with other functional groups to resolve difficult quality problems on products, processes, or materials used in manufacturing operations.\nDirect and facilitate investigations and the corresponding preventative actions and corrective actions that result from abnormal results, customer complaints, quality inquiries, and other quality performance indicators. \nTravel Requirements (including international): 0-5%\nSupport internal and external audits. Provide support for audit preparation activities. Participate in the back-room as needed.\nIn addition to the main responsibilities listed above the manager is allowed to USE discretion TO add further duties and tasks based on the business needs which are not explicitly listed here.\nMINIMUM REQUIREMENTS\nEducation and Experience\nB.S. degree in Engineering such as Electrical, Mechanical, or Biomedical Engineering and 2+ years of medical device experience (or equivalent work experience), or M.S. and 1+ years of medical device experience.\n1 year of experience in interpreting and applying Quality Systems Regulations and ISO quality requirements OR 1 year of experience in design controls, 21 CFR 820, ISO 13485, ISO 14971, EU MDR, and applicable medical device regulations.\nPREFERRED REQUIREMENTS\nProfessional certifications (CQE, CQA, CMQ/OE, Lead Auditor) are desirable.\nDesign for Six Sigma training is desired along with knowledge of statistical methodologies.\nInvolvement in back-room support process during external audits and/or inspections.\nExperience reviewing design verification and design validation protocols.\nOther Attributes\nExcellent communication, problem solving, organizational, and interpersonal skills are required.\nMust be capable to plan schedules and to manage multiple projects simultaneously.\nStrong technical writing skills.\nWorks independently with minimal direction or supervision.\nDecision intelligence.\nPhysical Requirements\nAbility to sit/stand for 8 hours.\nAbility to sit at a computer terminal for an extended period.\nN/A\nDisclosure as required by applicable law, the annual salary range for this position is $74,200 to $94,600. The actual compensation may vary based on geographic location, work experience, education and skill level. The salary range is CONMED’s good faith belief at the time of this posting.\nColorado residents: In any materials you submit, you may redact or remove age identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.\nIn addition to the main responsibilities listed above the manager is allowed to USE discretion TO add further duties and tasks based on the business needs which are not explicitly listed here.\n*****No visa sponsorship will be provided. Relocation assistance will be considered*****\nBenefits:\nCONMED offers a wide array of benefits to fit your unique needs. Visit our Benefits Page for more information.\nCompetitive compensation\nExcellent healthcare including medical, dental, vision and prescription coverage\nShort & long term disability plus life insurance -- cost paid fully by CONMED\nRetirement Savings Plan (401K) -- CONMED matches your contributions dollar for dollar, with the potential for up to 7% per pay period\nEmployee Stock Purchase Plan -- allows stock purchases at discounted price\nTuition assistance for undergraduate and graduate level courses\nKnow someone at CONMED? Have them submit you as a referral before applying for this position to be eligible for our Employee Referral Program incentives!\nCONMED is an equal opportunity employer and does not discriminate on the basis of any legally protected status or characteristic. Protected veterans and individuals with disabilities are encouraged to apply.The Know Your Rights: Workplace Discrimination is Illegal Poster reaffirms this commitment.\nColorado Residents: In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.\nIf you feel you need a reasonable accommodation pursuant to the ADA, you are encouraged to contact us at 800-929-7176 option #5.","description_format":"text","description_chars":6941,"description_truncated":false,"requirements":{"experience_years_min":2,"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","Relocation assistance","Retirement plans"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":true,"industries":["Health Care","Surgical Instruments & Devices","Health & Medical Electronics"],"lifecycle":[{"event":"open","at":"2026-09-29T08:45:11Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 2 · green card filings: 1","filings_12m":2,"filings_prev_12m":2,"green_card_filings_12m":1,"median_offered_wage_usd":99167,"route":null,"cap_exempt":false,"checked_at":"2026-10-03T21:08:04+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":31,"band":"fade","label":"Fading","p_open":1,"p_active":0.571,"p_room":0.55,"age_days":18,"expected_fill_days":14,"reasons":["conf:13","win:tail","comp:junior"],"computed_at":"2026-10-12T06:55:09Z"},"pay":{"stated_usd_annual":94600,"is_top_pay":true},"html_url":"https://alion.io/job/conmed-design-quality-engineer","json_url":"https://alion.io/job/conmed-design-quality-engineer.json","meta":{"generated_at":"2026-10-13T00:38:53Z","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":1087,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-14T00:00:00Z"}},"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":1896673},"rest":"https://alion.io/mcp/rest/get_company?id=1896673"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fconmed-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%2Fconmed-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%2Fconmed-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/conmed-design-quality-engineer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fconmed-design-quality-engineer"}]}