{"id":3430502,"url":"https://alion.io/job/midmark-rd-quality-engineer-ii","title":"R+D Quality Engineer II","company":{"id":2566834,"name":"Midmark","domain":"midmark.com","url":"https://alion.io/company/midmark","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Oracle","truth_index":{"grade":"B","score":79,"open_postings":8,"ghost_share":0,"stale_share":0.625,"repost_share":0,"time_to_fill_p50_days":62,"computed_at":"2026-11-06T05:58:05Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"middle","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Versailles, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":73000,"max_usd":133000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":4330},"experience_years_min":2,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"EU MDR","optional":false},{"name":"FMEA","optional":false},{"name":"Human Factors Engineering","optional":false},{"name":"ISO 13485","optional":false},{"name":"ISO 14971","optional":false},{"name":"Minitab","optional":false}],"status":"live","first_seen_at":"2026-10-28T19:02:46Z","employer_posted_date":"2026-10-28","last_verified_at":"2026-11-06T11:19:46Z","board_verified":true,"closed_at":null,"days_open":8,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":8},"description":"JOB SUMMARY:\nThe R + D Quality Engineer II leads product development quality initiatives through identifying, investigating, planning, and conducting activities aimed at insuring robust and quality design and manufacturability of medical devices.\nESSENTIAL/PRIMARY DUTIES:\nManages quality deliverables on new product development (NPD) projects in accordance with regulatory standards ISO9001:2015, ISO13485:2016, ISO14971, FDA, CSA, and EU MDR regulations.\nAssists with safety risk management processes and creation of risk management documentation for (NPD) projects.\nCreates, reviews, and approves documentation related to the engineering Product Realization Process (PRP). Documentation includes, but is not limited to, change requests, engineering orders, product and component test specifications and design records.\nFacilitates the design and process failure mode and effects analysis (FMEA) process.\nApplies advanced engineering methods and tools to solve engineering problems. Identifies and contributes to process improvements utilizing six sigma techniques.\nCollaborates with cross functional/development teams to address quality concerns, drive improvements, and take ownership of technical solutions and their outcomes.\nMentors co-op and engineer I teammates, focusing on technical skills and cultural competencies.\nExpands problem definition, integrates new information and different perspectives, and chooses optimal solution based on evidence.\nSECONDARY DUTIES:\nSupports internal and external quality system audits.\nAssists with the creation of threat models and cybersecurity risk assessments.\nAssists with the creation and maintenance of the products Usability Engineering Files, provides misuse cases involving use error and assesses the impact.\nAssists with the creation of the reliability predictions for projects with recommended testing profiles.\nEDUCATION and/or EXPERIENCE:\nBachelor's degree in engineering or related field and 2+ years of relevant experience, or equivalent combination of both. Six Sigma Blackbelt (DMAIC, DMADV) Certification is preferred.\nCOMPETENCY and/or SKILL:\nMastery of software programs - Microsoft Word, PowerPoint, Excel, Project, Minitab\nStrong written and verbal communication skills\nAdvanced analytical skills, ability to define and analyze complex problems\nAbility to generate alternatives and take reasonable risks to solve technical problems\nSUPERVISORY RESPONSIBILITIES:\nProvides leadership, coaching, and/or mentoring to co-op’s and level I engineers.","description_format":"text","description_chars":2511,"description_truncated":false,"requirements":{"experience_years_min":2,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":true},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Health Care"],"lifecycle":[{"event":"open","at":"2026-10-29T00:16:12Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 9 · green card filings: 1","filings_12m":9,"filings_prev_12m":0,"green_card_filings_12m":1,"median_offered_wage_usd":128500,"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)","US Department of Labor: PERM disclosure data (green cards)"],"filings_for_role_12m":0}],"liveness":{"score":90,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.903,"p_room":1,"age_days":8,"expected_fill_days":62,"reasons":["conf:8","velocity","win:early"],"computed_at":"2026-11-06T05:58:05Z"},"pay":null,"html_url":"https://alion.io/job/midmark-rd-quality-engineer-ii","json_url":"https://alion.io/job/midmark-rd-quality-engineer-ii.json","meta":{"generated_at":"2026-11-06T15:09:48Z","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":28210,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-07T00:00:00Z"}},"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":2566834},"rest":"https://alion.io/mcp/rest/get_company?id=2566834"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fmidmark-rd-quality-engineer-ii"},{"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%2Fmidmark-rd-quality-engineer-ii"},{"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%2Fmidmark-rd-quality-engineer-ii"},{"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/midmark-rd-quality-engineer-ii\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fmidmark-rd-quality-engineer-ii"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3430502}},{"tool":"search_jobs","arguments":{"company":"midmark.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3430502},"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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