{"id":1703071,"url":"https://alion.io/job/coopercos-design-quality-engineer-ii","title":"Design Quality Engineer II","company":{"id":2859488,"name":"CooperCompanies","domain":"coopercos.com","url":"https://alion.io/company/coopercos","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":80,"open_postings":12,"ghost_share":0,"stale_share":1,"repost_share":0,"time_to_fill_p50_days":14,"computed_at":"2026-10-09T06:01:00Z"}},"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":["Trumbull, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":61000,"max_usd":113000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":2884},"experience_years_min":3,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-09-30T13:41:39Z","employer_posted_date":"2026-09-30","last_verified_at":"2026-10-10T00:34:43Z","board_verified":true,"closed_at":null,"days_open":9,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":9},"description":"The Design Quality Engineer II provides Design Quality Engineering support to ensure the successful development of Cooper products and ongoing operational support, applying knowledge of design control principles and quality engineering techniques to support development efforts and address quality-related challenges. This role is responsible for ensuring products are developed and manufactured in accordance with applicable industry standards, regulatory requirements, and customer expectations, and reviews and evaluates scientific and technical data related to product development and testing, contributing to problem-solving activities for product and process improvements, while collaborating with cross-functional teams and providing guidance when appropriate.\n Quality RepresentationActively represent Quality function on product/process development teams. \nSupport engineering teams to ensure design control requirements are met effectively, including design verification, validation, specifications, procedures, risk management, and design reviews. \n\nSupplier EngagementSupport supplier tooling activities to help ensure components are qualified on time, including use of PPAP tools. \nParticipate in supplier selection activities and specification reviews to help ensure purchased components meet requirements. \nCollaborate with Engineering to define quality characteristics and inspection plans for components, subassemblies, and finished devices. \n\nCAPAs/Non conformancesParticipate in investigations of product and process issues; contribute to root cause analysis and corrective actions. \nSupport evaluation and disposition of nonconforming materials used in development, pilot, or clinical builds in accordance with quality system requirements. \n\nDesign Participate in design reviews to evaluate designs and provide quality-related feedback. \nContribute to early stages of product development, including prototype evaluation, testing, and cross-functional collaboration. \nProvide input to design and manufacturing documentation (e.g., specifications, drawings, inspection procedures) to support manufacturability and testability. \nContribute to development of design input requirements based on prior product knowledge, historical issues, and competitive insights.\n\nV&VSupport development of the master test plans (I.E. trace matrix, VMP….) that encompass design verification, design validation and process validation activities. \nContribute to development, evaluation, and validation of product and process test methods. \nReview test protocols and reports to ensure that the testing is sufficient to meet regulatory requirements and quality objectives. \n\nRiskIdentifies and manages risk throughout the development process with the use of FMEAs and/or other risk management tools. This includes leading the Risk management efforts of the design process and working with design team and management team on managing product and process risks.\n\nProcess ImprovementIdentifies and contributes to improvements across all cross functional departments.\nPromotes continuous improvement in design control activities and use of quality tools with design team and other departments.\n\nRegulatoryComply with applicable FDA and international regulatory laws/standards and the Cooper’s Code of Conduct. \nMaintain knowledge of current regulatory requirements and standards as they pertain to the development and release of medical devices. \nSupport Cooper as needed in FDA, notified body, internal, and other audits. \n\nPerform other duties as assigned.\nTravel: \nThis position may require 0-5% domestic and/or international travel. \nQualifications\nKnowledge, Skills and Abilities:\nWorking knowledge of applicable laws and regulations. \nIntermediate skill in the use of Excel, Word and PowerPoint. Advanced preferred. \nAbility to read and understand highly technical material. \nProficient in reading and writing in English\nSelf-motivated and committed to a team approach \nEffective oral, presentation and technical writing skills \nDemonstrated ability to support decision making within quality engineering responsibilities\nExperience collaborating with cross-functional teams in a medical device development environment. \nStrong analytical and problem-solving skills with acute attention to detail. \nGood communication and interpersonal skills. \nWork Environment:\nProduction/Clean Room/Warehouse/Office Environment which may require long periods of sitting, standing, or getting up and down throughout the day.\nOccasionally lift to 35 pounds.\nExperience:\n3+ years experience in Quality Engineering in the medical device industry. Experience in related engineering areas, e.g. R&D; or Manufacturing may also be applicable if experience includes work responsibilities listed above. \nExperience in medical devices, with knowledge in women’s health preferred.\nEducation:\nBachelor’s Degree or higher in Science or Engineering (or related field).","description_format":"text","description_chars":4936,"description_truncated":false,"requirements":{"experience_years_min":3,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[{"language":"English","level":"All levels","optional":false}]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Lifestyle"],"lifecycle":[{"event":"open","at":"2026-10-02T14:01:44Z"}],"visa":[],"liveness":{"score":48,"band":"ok","label":"Likely open","p_open":1,"p_active":0.533,"p_room":0.9,"age_days":8,"expected_fill_days":14,"reasons":["conf:1","stale_co","velocity","win:mid","comp:brand"],"computed_at":"2026-10-09T06:01:00Z"},"pay":null,"html_url":"https://alion.io/job/coopercos-design-quality-engineer-ii","json_url":"https://alion.io/job/coopercos-design-quality-engineer-ii.json","meta":{"generated_at":"2026-10-10T01:00:07Z","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","counted_by":"address","units_charged":1,"used_today":1605,"day_limit":5000,"remaining_today":3395,"minute_limit":60,"resets_at":"2026-10-11T00:00:00Z"}},"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":2859488},"rest":"https://alion.io/mcp/rest/get_company?id=2859488"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fcoopercos-design-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%2Fcoopercos-design-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%2Fcoopercos-design-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/coopercos-design-quality-engineer-ii\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fcoopercos-design-quality-engineer-ii"}]}