{"id":1695186,"url":"https://alion.io/job/deka-research-development-product-complaints-engineer-deka-research-development","title":"Product Complaints Engineer - DEKA Research & Development","company":{"id":2016025,"name":"DEKA Research & Development","domain":"dekaresearch.com","url":"https://alion.io/company/dekaresearch","size_band":"51-200","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"JazzHR","truth_index":null},"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":["Manchester, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":66000,"max_usd":121000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":3300},"experience_years_min":3,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false}],"status":"live","first_seen_at":"2026-10-02T12:01:51Z","employer_posted_date":"2026-10-02","last_verified_at":"2026-10-11T17:01:28Z","board_verified":true,"closed_at":null,"days_open":9,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":9},"description":"DEKA R&D, on behalf of Millyard Advanced Medical Products, is looking for a Product Complaints Engineer to work in a dynamic Medical Device Research and Development environment. The position reports to the Product Complaints Manager. This is a high visibility role with a significant direct impact in the Quality Management System.\nHow you will make an impact:\nResponsible for reviewing complaints related to potential medical device issues. \nPerform product complaint evaluations with minimal direction, utilizing experience and product knowledge.\nEnsure that complaint documentation follows Good Documentation Practices; meets QMS requirements; and complies with U.S. Food and Drug Administration (FDA) regulations / other regulatory requirements.\nIdentify and make sound decisions regarding medical device reporting to regulatory agencies.\nInterface with Third Party Manufacturers, health care professionals, internal customers, and regulatory agencies.\nParticipate in audits and CAPA investigations as they relate to complaint handling.\nWork with the forensic investigation team to align product investigations related to complaints.\nGenerate reports to identify areas of process improvement.\nDevelop product training aids.\nContribute independently while also collaborating with other team members and departments needing product complaint information.\nMaintain positive and cooperative communication with co-workers, customers, contractors, and vendors.\nServe as a subject matter expert on complaint handling.\nPerform other related duties as assigned under management supervision.\nSkills Needed to Be SuccessfulBachelor's degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, Quality Engineering, or a related technical discipline required.\n Minimum of 3-5 years of experience in a regulated medical device, pharmaceutical, or life sciences environment, with direct responsibility for complaint investigations, product quality investigations, product analysis, and complaint closure activities.\nDemonstrated experience conducting complaint investigations, determining root cause, documenting investigation results, and independently driving records to closure in compliance with established timelines.\nWorking knowledge of FDA Quality System Regulations, Medical Device Reporting requirements, and applicable standards, including 21 CFR Parts 803 and 820; experience with ISO 13485 is preferred.\nExperience evaluating product complaints for reportability and supporting regulatory submissions is preferred.\nExperience using electronic quality management systems (eQMS), complaint handling systems, and platforms such as Salesforce is preferred.\nStrong technical troubleshooting, analytical, and problem-solving skills with the ability to assess complex product performance issues and identify potential failure modes.\nExceptional time management skills with the ability to manage a high-volume complaint workload while meeting regulatory and internal closure targets.\nExcellent technical writing skills with demonstrated ability to prepare clear, concise, and compliant investigation reports.\nStrong written and verbal communication skills with the ability to effectively interact with Quality, Regulatory, Engineering, Manufacturing, Clinical, and Customer Support teams.\nHighly organized, detail-oriented, and self-motivated with the ability to work independently and make sound decisions based on available evidence.\nAbility to thrive in a fast-paced, changing environment while maintaining compliance with regulations, procedures, and quality system requirements.\nAbout Millyard Advanced Medical Products:\nhttps://millyardadvanced.com/\nLocated in the heart of the Regen Valley in Manchester, NH, our company aims to positively influence the healthcare landscape.\nEstablished 2019\nSelected Partners\nContract Designer: DEKA Research & Development\nContract Manufacturer: Merrimack Manufacturing\nAbout DEKA:\nOne hour from the beach, Boston, and the mountains, the historic Amoskeag Millyard once housed the largest textile mills in the world. It is now home to DEKA Research and Development, where we are taking the same innovation and cutting-edge technology into the modern age.\nBehind DEKA’s brick walls sits a team of professionals who strive to make a difference every day through thoughtful engineering, design, and manufacturing. Here at DEKA, some of the most innovative and life-changing products of our time are created, and new ideas are always welcome and explored.","description_format":"text","description_chars":4510,"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":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":[],"lifecycle":[{"event":"open","at":"2026-10-02T12:01:51Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 12 · green card filings: 1","filings_12m":12,"filings_prev_12m":14,"green_card_filings_12m":1,"median_offered_wage_usd":110962,"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":89,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.887,"p_room":1,"age_days":7,"expected_fill_days":33,"reasons":["conf:0","velocity","win:early"],"computed_at":"2026-10-10T05:45:15Z"},"pay":null,"html_url":"https://alion.io/job/deka-research-development-product-complaints-engineer-deka-research-development","json_url":"https://alion.io/job/deka-research-development-product-complaints-engineer-deka-research-development.json","meta":{"generated_at":"2026-10-11T20:39:26Z","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":8897,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-12T00:00:00Z"}},"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":2016025},"rest":"https://alion.io/mcp/rest/get_company?id=2016025"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fdeka-research-development-product-complaints-engineer-deka-research-development"},{"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%2Fdeka-research-development-product-complaints-engineer-deka-research-development"},{"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%2Fdeka-research-development-product-complaints-engineer-deka-research-development"},{"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/deka-research-development-product-complaints-engineer-deka-research-development\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fdeka-research-development-product-complaints-engineer-deka-research-development"}]}