About this role
Technical Lead for Biosurgery new product development in the MedTech space, responsible for integrating chemistry, device engineering, and process development to deliver manufacturable, regulatory-ready biosurgical devices.
Key Responsibilities
- Single technical lead for assigned NPD project
- Develop integrated technical plan across formulation, device design, and process development
- Coordinate crossfunctional inputs and manage technical risks
- Lead design reviews and technical gating decisions
- Ensure regulatory submissions and manufacturing transfer readiness
Technical Overview
Scope includes formulation chemistries, device mechanics, process development, and regulatory submission support within a biosurgery portfolio, with emphasis on DFMEA and ISO 13485/FDA 21 CFR knowledge.
Ideal Candidate
The ideal candidate is a mid-to-senior technical lead with 6+ years in NPD for medical devices, strong background in device mechanics and formulation chemistry, and proven ability to lead cross-functional teams through DFMEA, design controls, and regulatory submissions.
Must-Have Skills
8+ years (BS) or 6+ years (MS/PhD) of industry experience in new product development for medical devicescombination productsor biomaterialsDemonstrated experience acting as technical lead or technical program manager on device or combination-product development projectsStrong technical background across formulation chemistriesdevice mechanicsprocess developmentmaterialsand analytical characterizationPractical experience with design controlsrisk management (DFMEA)verification/validation planningand regulatory submission supportTravel up to 25%
Nice-to-Have Skills
ISO 13485FDA 21 CFR knowledgeBiosurgery product types (hemostatssealantsadhesiveshydrogels)
Required Skills
8+ years (BS) or 6+ years (MS/PhD) of industry experience in new product development for medical devicescombination productsor biomaterialsdesign controlsDFMEAverification/validationregulatory submissionsformulation chemistriesdevice mechanicsprocess developmentbiocompatibility
Hard Skills
BS/MS/PhD in Engineering (BiomedicalMechanicalChemical)Materials ScienceChemistryor related technical discipline8+ years (BS) or 6+ years (MS/PhD) of industry experience in new product development for medical devicescombination productsor biomaterialsTechnical lead or technical program manager on device or combination-product development projectsFormulation chemistriesDevice mechanicsProcess developmentBiocompatibilityDesign controlsRisk management (DFMEA)Verification/validation planningRegulatory submission supportISO 13485 (preferred)FDA 21 CFR knowledge (preferred)
Soft Skills
Excellent written and verbal communicationMatrix leadershipCross-functional collaborationProblem-solvingData-driven decision making
Keywords for Your Resume
technical leadnew product developmentbiosurgerymedtechmedical devicesdevice developmentdesign controlsDFMEAverification/validation planningregulatory submissionISO 13485FDA 21 CFRformulation chemistrydevice mechanicsprocess developmentbiocompatibilitytravel up to 25%
Deal Breakers
6+ years of NPD medical device experience, Willingness to travel up to 25%, On-site work in Raritan, NJ
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