{"schemaVersion":"jobsearcher.job.v1","id":"e04f4007d4f793053d71061c","url":"https://jobsearcher.com/jobs/e04f4007d4f793053d71061c","canonicalUrl":"https://jobsearcher.com/jobs/e04f4007d4f793053d71061c","title":"Senior Device Engineer","description":"Overview Join our growing Manufacturing team at Celldex as we enter an exciting phase of our company. The Senior Device Engineer will drive the end-to-end development of a device combination product within our Immunology/Inflammation therapeutic areas. The position will provide comprehensive leadership in engineering product management, regulatory compliance (design controls), and multi‑functional collaboration with internal and external partners, for the combination product device.\nResponsibilities Sourcing Human Factors Consultants to execute Human Factors Studies\nManage the device design and development lifecycle of a combination product development.\nDefines product requirements and specifications with commercial, clinical, and other development/strategy collaborators.\nResponsible for all user needs and requirements to be validated through design and development.\nDevelops, manages, and communicates development program plans, risks, timelines, and budgets to internal and external team members.\nIntegrate device development activities with CMC and Global development timing and goals.\nLeads all aspects of product testing for the specific device development.\nManages the development and the updates to the Design History File (DHF) to meet regulatory and quality requirements (21CFR Part 3 and 21 CFR 820.30).\nDrafts the regulatory device development sections (ie: IND/IMPD, BLA Submission, etc.)\nSupports and generates timelines for the device development and launch activities of a new combination product.\nManage device verification testing to support functional (EDDOs) release and stability requirements.\nEnsure compliance and quality by working with Celldex Quality team\nQualifications Bachelor’s degree in a science‑related field - Engineering preferred.\n8+ Years of experience in device and integrated combination product development, including comprehensive understanding of pharmaceutical and delivery system processes.\nProven experience with pre‑filled syringes and autoinjectors in a regulated environment, is a plus\nExperience in developing and implementing process changes and improvements for combination products or medical devices.\nPossess strong project management and interpersonal skills and strong analytical and problem‑solving capabilities.\nCan work effectively across multiple functional teams.\nEnjoys working in a fast‑paced, multifaceted research and development environment.\nWilling and able to travel less than 10% to investigate partners, perform audits, and for project coordination activities.\nProficient in Word, Excel, PowerPoint, and SharePoint\nExcellent communication, problem‑solving, and project management skill\nCompensation The expected base salary range for this position is $133,579 to $173,480.\nWe are committed to compensating employees equitably based on several factors including experience, education, licensure/certifications, skill level, location of the position, and availability of similar talent in a competitive market.\nCompensation for this role includes base salary, annual discretionary bonus, long term incentive, 401(K) plan with employer contribution, health care and other insurance benefits (for employee and family), paid holidays, vacation, and sick days. A summary of our benefits can be found on our careers page.\nCelldex is proud to be an equal opportunity employer that strives to foster a culture of diversity, equity, and inclusion. We are committed to promoting a diverse environment through development, recruiting and community outreach.\n\n#J-18808-Ljbffr","company":"Celldex","rawCompany":"celldex","city":"Hampton","state":"VA","isRemote":false,"isActive":false,"createdAt":"2026-06-20T04:38:53.603Z","occupations":[{"code":"17-2031.00","title":"Bioengineers and Biomedical Engineers","slug":"bioengineers-and-biomedical-engineers"},{"code":"17-2199.00","title":"Engineers, All Other","slug":"engineers-all-other"},{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"}],"industries":[{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"},{"code":"334510","title":"Electromedical and Electrotherapeutic Apparatus Manufacturing","slug":"electromedical-and-electrotherapeutic-apparatus-manufacturing"},{"code":"541714","title":"Research and Development in Biotechnology (except Nanobiotechnology)","slug":"research-and-development-in-biotechnology-except-nanobiotechnology"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Senior Device Engineer","description":"Overview Join our growing Manufacturing team at Celldex as we enter an exciting phase of our company. The Senior Device Engineer will drive the end-to-end development of a device combination product within our Immunology/Inflammation therapeutic areas. The position will provide comprehensive leadership in engineering product management, regulatory compliance (design controls), and multi‑functional collaboration with internal and external partners, for the combination product device.\nResponsibilities Sourcing Human Factors Consultants to execute Human Factors Studies\nManage the device design and development lifecycle of a combination product development.\nDefines product requirements and specifications with commercial, clinical, and other development/strategy collaborators.\nResponsible for all user needs and requirements to be validated through design and development.\nDevelops, manages, and communicates development program plans, risks, timelines, and budgets to internal and external team members.\nIntegrate device development activities with CMC and Global development timing and goals.\nLeads all aspects of product testing for the specific device development.\nManages the development and the updates to the Design History File (DHF) to meet regulatory and quality requirements (21CFR Part 3 and 21 CFR 820.30).\nDrafts the regulatory device development sections (ie: IND/IMPD, BLA Submission, etc.)\nSupports and generates timelines for the device development and launch activities of a new combination product.\nManage device verification testing to support functional (EDDOs) release and stability requirements.\nEnsure compliance and quality by working with Celldex Quality team\nQualifications Bachelor’s degree in a science‑related field - Engineering preferred.\n8+ Years of experience in device and integrated combination product development, including comprehensive understanding of pharmaceutical and delivery system processes.\nProven experience with pre‑filled syringes and autoinjectors in a regulated environment, is a plus\nExperience in developing and implementing process changes and improvements for combination products or medical devices.\nPossess strong project management and interpersonal skills and strong analytical and problem‑solving capabilities.\nCan work effectively across multiple functional teams.\nEnjoys working in a fast‑paced, multifaceted research and development environment.\nWilling and able to travel less than 10% to investigate partners, perform audits, and for project coordination activities.\nProficient in Word, Excel, PowerPoint, and SharePoint\nExcellent communication, problem‑solving, and project management skill\nCompensation The expected base salary range for this position is $133,579 to $173,480.\nWe are committed to compensating employees equitably based on several factors including experience, education, licensure/certifications, skill level, location of the position, and availability of similar talent in a competitive market.\nCompensation for this role includes base salary, annual discretionary bonus, long term incentive, 401(K) plan with employer contribution, health care and other insurance benefits (for employee and family), paid holidays, vacation, and sick days. A summary of our benefits can be found on our careers page.\nCelldex is proud to be an equal opportunity employer that strives to foster a culture of diversity, equity, and inclusion. We are committed to promoting a diverse environment through development, recruiting and community outreach.\n\n#J-18808-Ljbffr","datePosted":"2026-06-20T04:38:53.603Z","dateModified":"2026-06-20T04:38:53.603Z","hiringOrganization":{"@type":"Organization","name":"Celldex","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Hampton","addressRegion":"VA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"e04f4007d4f793053d71061c"},"url":"https://jobsearcher.com/jobs/e04f4007d4f793053d71061c"}}