{"schemaVersion":"jobsearcher.job.v1","id":"dbfb742198dbe4bc1acbfd1e","url":"https://jobsearcher.com/jobs/dbfb742198dbe4bc1acbfd1e","canonicalUrl":"https://jobsearcher.com/jobs/dbfb742198dbe4bc1acbfd1e","title":"Usability Engineer","description":"We are looking for an Advanced Quality Engineer to join our Medical Device team to support an M&A project!\nKey areas of responsibility for integration\n Lead risk management and usability activities for remediation of existing legacy risk and usability documentation to company documentation and forms.\n Ensure quality assurance documentation to support integration activities and regulatory submissions.\n Partner with cross-functional project teams to support product integration activities.\n Evaluate overall residual risk for products and present final risk/benefit justification to executive leadership.\n Identified risks associated with the product use (usability)\n Track the design, documentation, and manufacturing process mitigation activities for all risks.\n Partner with cross-functional project teams to confirm design verification and validation test requirements that ensure appropriate objective evidence is available to support the acceptance criteria.\n Analyze market data (clinical and Post-Market) for risk estimation and address concerns.\nEducation/ work experience\n BS in a science, engineering or related discipline.\n MS, CQE, or CRE preferred.\n Six Sigma Green or Black belt preferred.\n Minimum of 5 years experience preferred.\nKnowledge/ competencies\n Experience with medical device product development lifecycle, including risk management, usability, and design/process verification and validation.\n Demonstrated applied knowledge of Advanced Quality tools such as Failure Modes Effect Analysis (FMEA), GD&T, Root Cause Analysis, and Mistake Proofing/Poke Yoke.\n Demonstrated ability to read and interpret CAD drawings.\n Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) required.\n Thorough knowledge and understanding of US and International Medical Device Regulations.\n Strong knowledge of Quality Concepts (e.g. CAPA, Audits, Statistics).\n Must possess strong project management skills as well as have the ability to manage multiple tasks simultaneously.\nJob Types: Full-time, Contract\nPay: $100,000.00 - $110,000.00 per year\nBenefits:\n401(k)\nDental insurance\nEmployee discount\nHealth insurance\nHealth savings account\nPaid time off\nReferral program\nVision insurance\nCompensation Package:\nHourly pay\nSchedule:\n8 hour shift\nMonday to Friday\nWeekends as needed\nEducation:\nMaster's (Preferred)\nExperience:\nMedical Device: 5 years (Required)\nUX: 5 years (Required)\nFMEA: 5 years (Required)\nGD&T: 5 years (Required)\nRisk Management: 5 years (Required)\nProduct Development Lifecycle: 5 years (Required)\nAdvanced Quality Engineering: 5 years (Required)\nFormative and Summative: 5 years (Required)\nIEC 62366: 5 years (Required)\nWork Location: Remote","company":"Actalent","rawCompany":"actalent","city":"Remote","state":"OR","isRemote":false,"isActive":false,"createdAt":"2026-08-04T14:34:32.319Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"19-4099.01","title":"Quality Control Analysts","slug":"quality-control-analysts"},{"code":"17-2112.01","title":"Human Factors Engineers and Ergonomists","slug":"human-factors-engineers-and-ergonomists"}],"industries":[{"code":"334510","title":"Electromedical and Electrotherapeutic Apparatus Manufacturing","slug":"electromedical-and-electrotherapeutic-apparatus-manufacturing"},{"code":"339113","title":"Surgical Appliance and Supplies Manufacturing","slug":"surgical-appliance-and-supplies-manufacturing"},{"code":"339112","title":"Surgical and Medical Instrument Manufacturing","slug":"surgical-and-medical-instrument-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Usability Engineer","description":"We are looking for an Advanced Quality Engineer to join our Medical Device team to support an M&A project!\nKey areas of responsibility for integration\n Lead risk management and usability activities for remediation of existing legacy risk and usability documentation to company documentation and forms.\n Ensure quality assurance documentation to support integration activities and regulatory submissions.\n Partner with cross-functional project teams to support product integration activities.\n Evaluate overall residual risk for products and present final risk/benefit justification to executive leadership.\n Identified risks associated with the product use (usability)\n Track the design, documentation, and manufacturing process mitigation activities for all risks.\n Partner with cross-functional project teams to confirm design verification and validation test requirements that ensure appropriate objective evidence is available to support the acceptance criteria.\n Analyze market data (clinical and Post-Market) for risk estimation and address concerns.\nEducation/ work experience\n BS in a science, engineering or related discipline.\n MS, CQE, or CRE preferred.\n Six Sigma Green or Black belt preferred.\n Minimum of 5 years experience preferred.\nKnowledge/ competencies\n Experience with medical device product development lifecycle, including risk management, usability, and design/process verification and validation.\n Demonstrated applied knowledge of Advanced Quality tools such as Failure Modes Effect Analysis (FMEA), GD&T, Root Cause Analysis, and Mistake Proofing/Poke Yoke.\n Demonstrated ability to read and interpret CAD drawings.\n Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) required.\n Thorough knowledge and understanding of US and International Medical Device Regulations.\n Strong knowledge of Quality Concepts (e.g. CAPA, Audits, Statistics).\n Must possess strong project management skills as well as have the ability to manage multiple tasks simultaneously.\nJob Types: Full-time, Contract\nPay: $100,000.00 - $110,000.00 per year\nBenefits:\n401(k)\nDental insurance\nEmployee discount\nHealth insurance\nHealth savings account\nPaid time off\nReferral program\nVision insurance\nCompensation Package:\nHourly pay\nSchedule:\n8 hour shift\nMonday to Friday\nWeekends as needed\nEducation:\nMaster's (Preferred)\nExperience:\nMedical Device: 5 years (Required)\nUX: 5 years (Required)\nFMEA: 5 years (Required)\nGD&T: 5 years (Required)\nRisk Management: 5 years (Required)\nProduct Development Lifecycle: 5 years (Required)\nAdvanced Quality Engineering: 5 years (Required)\nFormative and Summative: 5 years (Required)\nIEC 62366: 5 years (Required)\nWork Location: Remote","datePosted":"2026-08-04T14:34:32.319Z","dateModified":"2026-08-04T14:34:32.319Z","hiringOrganization":{"@type":"Organization","name":"Actalent","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Remote","addressRegion":"OR","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"dbfb742198dbe4bc1acbfd1e"},"url":"https://jobsearcher.com/jobs/dbfb742198dbe4bc1acbfd1e"}}