{"id":2546948,"url":"https://alion.io/job/forjmedical-design-development-quality-engineer-ii","title":"Design & Development Quality Engineer II","company":{"id":3839692,"name":"Forjmedical","domain":"forjmedical.com","url":"https://alion.io/company/forjmedical","size_band":"501-1000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Dayforce","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":["Saint Paul, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":60000,"max_usd":110000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":3690},"experience_years_min":3,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-07-22T06:00:00Z","employer_posted_date":"2026-10-14","last_verified_at":"2026-10-19T15:05:23Z","board_verified":true,"closed_at":null,"days_open":89,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":89},"description":"Job Summary: \nDesign and Development Quality Engineers drive project quality in all areas including all deliverables and ensure that development teams follow processes that are effective and compliant to SOPs. They work with both the customer and internal team members to drive successful outcomes and long-term value for both the customer and Forj Medical. Design and Development Quality Engineer II will work under the direction/supervision of more senior Design QA staff members to ensure resolution of technical issues and knowledge transfer. They assist in the development of verification and validation activities on medical devices and medical device systems. Verification testing may involve GUI testing, black-box system testing, environmental testing, requirements based functional testing and low-level hardware testing and fault simulation.\n\nJob Duties and Responsibilities:\nParticipates/Approves in development of requirements, technical Reviews, test report development, design transfer coordination/support and FMEA, DFMEA development \nParticipates in project/customer meetings and Leads Phase Reviews\nMonitors project activities to ensure following Forj Medical processes. \nCollaborated with Supplier Quality to assure all new suppliers are qualified and that new components and materials are adequately qualified.\nUses cross functional knowledge to be able to support teammates in constraints arise\nReviews/Approves regression analysis, Trace Matrix, ECOs, DBRs, DV Tool Qualifications, Test Procedures.\nManages and monitors Design and Development (DDF) file including creating development planning documents and verification reports. \nMonitors Test Execution Management, Device Testing, Dry Run Status, Stage Build Process Compliance, and Safety/EMC Test Reports \nDrives Design Change assessments including planning and report documentation with cross functional support.\nAssists in the generation and/or execution of verification test procedures. \nEnsures verification configurations tested are production equivalent by collaborating with other engineering disciplines and early stage to build knowledge.\nOther duties as assigned\n\nRequired Qualifications\nBachelor’s Degree/Technical Degree in Engineering or equivalent experience \n3-5 years’ experience in a Medical Device manufacturing/product development environment \nUnderstanding of FDA QMSR, ISO 13485, IEC 60601, and IEC 62304 requirements \nExperience/knowledge with product/process verifications/validations \nExperience with DFMEAs, PFMEAs, Risk Management, Equipment Qualifications, and Statistical analysis\n\nPreferred Qualifications:\nCertified Quality Engineer (CQE) or equivalent experience\nMust possess good project management skills and initiative in taking on and completing projects \nMust possess good verbal and written communication skills \nMust be able to manage and prioritize multiple projects/objectives \nStrong interpersonal, teamwork, and communication skills. \nStrong written communication demonstrating the ability to simplify complex information. \nWorking Conditions:\nOffice environment\nManufacturing environment","description_format":"text","description_chars":3106,"description_truncated":false,"requirements":{"experience_years_min":3,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Consumer Electronics","Electrical & Electronic Engineering","Health & Medical 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