{"id":1813105,"url":"https://alion.io/job/biomerics-design-assurance-quality-engineer","title":"Design Assurance Quality Engineer","company":{"id":3854448,"name":"Biomerics","domain":"biomerics.com","url":"https://alion.io/company/biomerics","size_band":"501-1000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Paylocity","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":["Brooklyn Park, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":67000,"max_usd":127000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":5966},"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-09-16T16:16:15Z","employer_posted_date":"2026-10-03","last_verified_at":"2026-10-24T02:44:17Z","board_verified":true,"closed_at":null,"days_open":37,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":37},"description":"Description\nCompany Overview\nBiomerics is a world-class manufacturer and innovative polymer solutions provider for the medical device and biotech indus-tries. As a vertically integrated company, we specialize in designing, developing, and producing medical devices for diagnostic and interventional procedures. We are focused on next-genera-tion solutions for vascular access, electrophysiology, cardiac rhythm management, neurovascular, structural heart, and cardiovascular markets.\nAt Biomerics, we are dedicated to our diverse employee base. We understand that a strong, skilled, and engaged workforce is the foundation of our continued success as a business. We strive to live up to Biomerics' values in all our interactions. It is an exciting time to be part of our collective team, and there is no limit to the impact that can be achieved here at Biomerics. We improve and advance the lives of our employees and the patients who depend on our products.\nAt Biomerics, we believe in integrity, partnership, empowerment and accountability, trust, agility, teamwork, and excellence, and we care. Our team-oriented, customer-focused corporate culture prioritizes building strategic, mutually beneficial partnerships with customers and our team members.\nJob Description\nThe Design Assurance Quality Engineer provides Quality Engineering support for new product development (NPD) projects from concept through design transfer and commercialization, while also supporting sustaining engineering activities for existing products throughout their lifecycle. This position partners with Design Engineering, Manufacturing Engineering, Operations, Supplier Quality, Business Development, and Quality to ensure customer, quality, and regulatory requirements are appropriately incorporated throughout product development and ongoing product support.\nThe Design Assurance Quality Engineer supports design controls, risk management, verification and validation, supplier and material qualification, design transfer, and product/process change activities in accordance with the Quality Management System (QMS) and applicable regulatory requirements. This position reports to the Site Quality Manager.\nResponsibilities\nExecute design, development, and validation activities throughout the product life cycle in accordance with project scope.\nUtilize the Design Control process to create cost-effective and efficiently manufacturable products.\nContribute to deliverables in compliance with MDR, ISO, and EN standards.\nTranslate customer specifications and requirements into clear, concise performance and functional requirements.\nConduct engineering evaluations, characterizations, design of experiments (DOE), bench testing, and other verification activities to improve and confirm design and process capabilities.\nTrain and guide development technicians/operators in hands-on prototyping, testing, and process development.\nExecute document change requests and effectively train development/production operators and technicians on updated documentation.\nDesign, procure, install, qualify, document, and train on new tooling/fixturing.\nEvaluate and implement new technologies and ideas for product improvement.\nUse statistical tools to analyze data and make development decisions to enhance process capability.\nDevelop and refine manufacturing procedures and test/inspection plans to ensure quality requirements are met and manufacturing process risks are mitigated.\nRequirements\n Bachelor’s degree or technical degree in Engineering or a related technical field; equivalent education and experience may be considered. \nMinimum of 5 years of experience in a medical device manufacturing, product development, Quality Engineering, or related regulated environment. \nWorking knowledge of applicable FDA Quality System requirements, ISO 13485, and ISO 14971. \nExperience with medical device design controls and new product development processes. \nExperience with product and process verification and validation activities, including protocol development and execution. \nExperience with DFMEAs, PFMEAs, and Risk Management activities. \nUnderstanding of design transfer, manufacturing processes, production readiness, and sustaining engineering activities. \nStrong project management and organizational skills with demonstrated initiative in taking ownership of and completing assigned projects. \nStrong verbal and written communication skills, including the ability to effectively document technical and quality activities. \nAbility to work effectively within cross-functional project teams. \nAbility to manage and prioritize multiple projects, objectives, and deadlines in a fast-paced environment. \nStrong analytical and problem-solving skills with attention to detail. \nBiomerics offers the following benefits: Medical/Dental/Vision Insurance, Short-Term Disability, Long-Term Disability, Life Insurance, Paid Vacation Days, Paid Holidays, and 401k.\nPlease, No Recruitment Agency calls or emails (we are not using recruitment services for this or any other role posted).\nThe salary estimates are estimates from this job board and not a guarantee of Biomerics’ salary range.","description_format":"text","description_chars":5158,"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","Life insurance","Vision insurance"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Manufacturing","Electronics Manufacturing","Contract Manufacturing"],"lifecycle":[{"event":"open","at":"2026-10-03T22:11:42Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 3","filings_12m":3,"filings_prev_12m":0,"green_card_filings_12m":0,"median_offered_wage_usd":92500,"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, 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