{"schemaVersion":"jobsearcher.job.v1","id":"8344eefbd7e8a5eaf3e1ee64","url":"https://jobsearcher.com/jobs/8344eefbd7e8a5eaf3e1ee64","canonicalUrl":"https://jobsearcher.com/jobs/8344eefbd7e8a5eaf3e1ee64","title":"R&D Engineer","description":"Job Description The role involves leading integration workstreams, supporting design and quality system integration activities, and collaborating closely with engineering leadership, technical teams, quality, manufacturing, supplier engineering, and regulatory stakeholders.\r\nThis position plays a key role in shaping integration strategy and ensuring successful execution of downstream deliverables in a highly collaborative environment.\r\nRoles & Responsibilities Lead integration workstreams including interface definition, requirements alignment, planning, and technical execution.\r\nDrive technical decision-making across assigned deliverables in collaboration with engineering leadership.\r\nOwn and ensure completion of design control deliverables including user needs, design inputs/outputs, and traceability.\r\nSupport risk management documentation and mitigation strategy activities.\r\nLead verification & validation (V&V) planning and execution activities.\r\nSupport DHF development and maintenance in compliance with regulatory standards.\r\nLead or oversee test method development and validation activities to ensure integration readiness.\r\nConduct feasibility studies, prototype development, and iterative testing activities to optimize designs across device platforms.\r\nPerform root cause analysis, resolve complex technical issues, and proactively identify and mitigate integration risks.\r\nPartner cross-functionally with quality, manufacturing, supplier engineering, and regulatory teams to drive execution and alignment.\r\nInfluence cross-functional stakeholders and provide technical leadership without direct line management responsibility.\r\nCollaborate closely with engineering managers, technical leads, engineers, and lab/testing support teams in a highly collaborative environment.\r\nRequirements Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Materials Science, or related field. Advanced degree preferred.\r\n6+ years of industry experience or 4+ years with an advanced degree.\r\nStrong experience in medical device development within a design controls environment.\r\nExperience with catheter-based and/or single-use medical devices.\r\nProven ability to lead technical workstreams and influence cross-functional teams.\r\nStrong working knowledge of design controls, DHF documentation, risk management, V&V, traceability, and change control.\r\nAbility to work independently with minimal guidance.\r\nStrong problem-solving, communication, and stakeholder management skills.\r\nExperience with Windchill or similar PLM/quality systems preferred.\r\nExperience with DMR deliverables including prints, specification maps, and BOM creation preferred.\r\nExperience with test method development and validation preferred.\r\nBackground in balloon catheter or catheter-based systems preferred.\r\nFamiliarity with Class II/III medical device regulations and quality systems preferred.\r\nExperience with product or technology integration activities preferred.\r\nSelf-starter with strong accountability, adaptability, and ability to operate in ambiguity.\r\nJ-18808-Ljbffr","company":"Creative Solutions Services","rawCompany":"creative solutions services","city":"Raynham","state":"MA","isRemote":false,"isActive":false,"createdAt":"2026-06-19T00:49:29.660Z","occupations":[{"code":"17-2199.00","title":"Engineers, All Other","slug":"engineers-all-other"},{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"17-2141.00","title":"Mechanical Engineers","slug":"mechanical-engineers"}],"industries":[{"code":"339112","title":"Surgical and Medical Instrument Manufacturing","slug":"surgical-and-medical-instrument-manufacturing"},{"code":"541715","title":"Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)","slug":"research-and-development-in-the-physical-engineering-and-life-sciences-except-nanotechnology-and-biotechnology"},{"code":"339113","title":"Surgical Appliance and Supplies Manufacturing","slug":"surgical-appliance-and-supplies-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"R&D Engineer","description":"Job Description The role involves leading integration workstreams, supporting design and quality system integration activities, and collaborating closely with engineering leadership, technical teams, quality, manufacturing, supplier engineering, and regulatory stakeholders.\r\nThis position plays a key role in shaping integration strategy and ensuring successful execution of downstream deliverables in a highly collaborative environment.\r\nRoles & Responsibilities Lead integration workstreams including interface definition, requirements alignment, planning, and technical execution.\r\nDrive technical decision-making across assigned deliverables in collaboration with engineering leadership.\r\nOwn and ensure completion of design control deliverables including user needs, design inputs/outputs, and traceability.\r\nSupport risk management documentation and mitigation strategy activities.\r\nLead verification & validation (V&V) planning and execution activities.\r\nSupport DHF development and maintenance in compliance with regulatory standards.\r\nLead or oversee test method development and validation activities to ensure integration readiness.\r\nConduct feasibility studies, prototype development, and iterative testing activities to optimize designs across device platforms.\r\nPerform root cause analysis, resolve complex technical issues, and proactively identify and mitigate integration risks.\r\nPartner cross-functionally with quality, manufacturing, supplier engineering, and regulatory teams to drive execution and alignment.\r\nInfluence cross-functional stakeholders and provide technical leadership without direct line management responsibility.\r\nCollaborate closely with engineering managers, technical leads, engineers, and lab/testing support teams in a highly collaborative environment.\r\nRequirements Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Materials Science, or related field. Advanced degree preferred.\r\n6+ years of industry experience or 4+ years with an advanced degree.\r\nStrong experience in medical device development within a design controls environment.\r\nExperience with catheter-based and/or single-use medical devices.\r\nProven ability to lead technical workstreams and influence cross-functional teams.\r\nStrong working knowledge of design controls, DHF documentation, risk management, V&V, traceability, and change control.\r\nAbility to work independently with minimal guidance.\r\nStrong problem-solving, communication, and stakeholder management skills.\r\nExperience with Windchill or similar PLM/quality systems preferred.\r\nExperience with DMR deliverables including prints, specification maps, and BOM creation preferred.\r\nExperience with test method development and validation preferred.\r\nBackground in balloon catheter or catheter-based systems preferred.\r\nFamiliarity with Class II/III medical device regulations and quality systems preferred.\r\nExperience with product or technology integration activities preferred.\r\nSelf-starter with strong accountability, adaptability, and ability to operate in ambiguity.\r\nJ-18808-Ljbffr","datePosted":"2026-06-19T00:49:29.660Z","dateModified":"2026-06-19T00:49:29.660Z","hiringOrganization":{"@type":"Organization","name":"Creative Solutions Services","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Raynham","addressRegion":"MA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"8344eefbd7e8a5eaf3e1ee64"},"url":"https://jobsearcher.com/jobs/8344eefbd7e8a5eaf3e1ee64"}}