{"schemaVersion":"jobsearcher.job.v1","id":"754cd992a6e29b1fff28992f","url":"https://jobsearcher.com/jobs/754cd992a6e29b1fff28992f","canonicalUrl":"https://jobsearcher.com/jobs/754cd992a6e29b1fff28992f","title":"Design Controls Engineer","description":"Position Title: Design Controls Engineer\nLocation: Durham, NC\nRole Type: Long term contract\nPrimary Function of Position:\nThe Design Controls Engineer plays a vital role in developing safe and effective medical devices . As an embedded member of the New Product Development (R&D) team, they support the rapid and efficient development of new products, while ensuring that complete and transparent records of product designs are created and maintained. They work closely with a team of exceptionally talented engineers and design professionals developing highly innovative products for use in the operating room. Their work helps safeguard the integrity of the design and ensures that Design History Files (DHF’s) meet all regulatory requirements. The Design Controls Engineer demonstrates a strong sense of pride in their work output and a real interest in client technology, products, and applications.\nRoles & Responsibilities:\nResponsibilities:\nAssist the new product development team with compiling and updating of engineering design control documents for Design History Files, including risk analyses, requirements, trace reports, and design verification and validation test documentation.\nAssist the cross functional new product development team with architecting a holistic documentation/tracing structure that is easily maintained.\nSupport design team to produce high quality, consistent design documents that meet client design control processes.\nUse the requirements management database tool extensively to manage design control documents, and the links between document content.\nActivities:\nAssist subject matter experts with writing, reviewing, and/or editing documents required by client design control process, including requirements, risk analyses, specifications, test protocols, and design review checklists.\nCoordinate documentation and Engineering Change Orders (ECOs) related to major design reviews.\nProduce requirements trace mapping and associated documentation.\nUse Siemens Polarion as a tool to accomplish the following:\no Enter and edit documents.\no Create and edit requirements and test cases.\no Create trace links\no Produce reports using standard report templates. Create additional custom reports as needed.\no Produce trace reports.\nUse Agile as a tool to accomplish the following:\no Organize and structure Design History Files (DHF) using Design Control checklists.\no Prepare and submit ECOs for individual documents and for DHF Bill of Material (BOM) changes.\nWork with the Technical Publications department to assure that Manuals, Instructions for Use, Labels and Training Materials are consistent with design documentation. Create trace documents and protocols used to assist in this process.\nSkills, Experience, Education, & Training:\nMinimal Requirements\nBachelor’s Degree in engineering or other technical area\nAbility to understand complex technical information and translate into writing\nProven success recognizing critical issues with the ability to react quickly under pressure, and drive issues to closure by providing coordinated direction.\nAbility to manage challenging assignments and multiple assignments in parallel\nStrong planning, decision making, negotiating and change management skills\nAssertive, outgoing personality with an ability to work collaboratively within an engineering team\nExcellent writing and communication skills, and attention to detail\nSkilled in the use of Microsoft Excel, Microsoft Word, and Adobe Acrobat\nPreferred Requirements\nMinimum 8 years experience working in an ISO 9001 medical device product development environment or other regulated industry\nExperience writing and reviewing engineering (design control) documents, including specifications, test protocols and test reports\nSkilled in the use of Agile or similar lifecycle management system tool\nSkilled in the use of Integrity, Polarion or other requirements management tool\nDevelopment experience with complex systems with a combination of hardware and software\nExperience in Risk Analysis and Failure Modes and Effects Analysis (FMEAs)\nThank you\nJob Type: Contract\nPay: $40.00 - $48.33 per hour\nExpected hours: 40 per week\nSchedule:\n8 hour shift\nMonday to Friday\nWork Location: In person","company":"Dgn Technologies","rawCompany":"dgn technologies","city":"Durham","state":"NC","isRemote":false,"isActive":false,"createdAt":"2026-08-05T11:22:50.637Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"17-2199.00","title":"Engineers, All Other","slug":"engineers-all-other"},{"code":"17-2141.00","title":"Mechanical Engineers","slug":"mechanical-engineers"}],"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":"Design Controls Engineer","description":"Position Title: Design Controls Engineer\nLocation: Durham, NC\nRole Type: Long term contract\nPrimary Function of Position:\nThe Design Controls Engineer plays a vital role in developing safe and effective medical devices . As an embedded member of the New Product Development (R&D) team, they support the rapid and efficient development of new products, while ensuring that complete and transparent records of product designs are created and maintained. They work closely with a team of exceptionally talented engineers and design professionals developing highly innovative products for use in the operating room. Their work helps safeguard the integrity of the design and ensures that Design History Files (DHF’s) meet all regulatory requirements. The Design Controls Engineer demonstrates a strong sense of pride in their work output and a real interest in client technology, products, and applications.\nRoles & Responsibilities:\nResponsibilities:\nAssist the new product development team with compiling and updating of engineering design control documents for Design History Files, including risk analyses, requirements, trace reports, and design verification and validation test documentation.\nAssist the cross functional new product development team with architecting a holistic documentation/tracing structure that is easily maintained.\nSupport design team to produce high quality, consistent design documents that meet client design control processes.\nUse the requirements management database tool extensively to manage design control documents, and the links between document content.\nActivities:\nAssist subject matter experts with writing, reviewing, and/or editing documents required by client design control process, including requirements, risk analyses, specifications, test protocols, and design review checklists.\nCoordinate documentation and Engineering Change Orders (ECOs) related to major design reviews.\nProduce requirements trace mapping and associated documentation.\nUse Siemens Polarion as a tool to accomplish the following:\no Enter and edit documents.\no Create and edit requirements and test cases.\no Create trace links\no Produce reports using standard report templates. Create additional custom reports as needed.\no Produce trace reports.\nUse Agile as a tool to accomplish the following:\no Organize and structure Design History Files (DHF) using Design Control checklists.\no Prepare and submit ECOs for individual documents and for DHF Bill of Material (BOM) changes.\nWork with the Technical Publications department to assure that Manuals, Instructions for Use, Labels and Training Materials are consistent with design documentation. Create trace documents and protocols used to assist in this process.\nSkills, Experience, Education, & Training:\nMinimal Requirements\nBachelor’s Degree in engineering or other technical area\nAbility to understand complex technical information and translate into writing\nProven success recognizing critical issues with the ability to react quickly under pressure, and drive issues to closure by providing coordinated direction.\nAbility to manage challenging assignments and multiple assignments in parallel\nStrong planning, decision making, negotiating and change management skills\nAssertive, outgoing personality with an ability to work collaboratively within an engineering team\nExcellent writing and communication skills, and attention to detail\nSkilled in the use of Microsoft Excel, Microsoft Word, and Adobe Acrobat\nPreferred Requirements\nMinimum 8 years experience working in an ISO 9001 medical device product development environment or other regulated industry\nExperience writing and reviewing engineering (design control) documents, including specifications, test protocols and test reports\nSkilled in the use of Agile or similar lifecycle management system tool\nSkilled in the use of Integrity, Polarion or other requirements management tool\nDevelopment experience with complex systems with a combination of hardware and software\nExperience in Risk Analysis and Failure Modes and Effects Analysis (FMEAs)\nThank you\nJob Type: Contract\nPay: $40.00 - $48.33 per hour\nExpected hours: 40 per week\nSchedule:\n8 hour shift\nMonday to Friday\nWork Location: In person","datePosted":"2026-08-05T11:22:50.637Z","dateModified":"2026-08-05T11:22:50.637Z","hiringOrganization":{"@type":"Organization","name":"Dgn Technologies","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Durham","addressRegion":"NC","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"754cd992a6e29b1fff28992f"},"url":"https://jobsearcher.com/jobs/754cd992a6e29b1fff28992f"}}