Project Manager /Medical Device -Boston area based

MUST BE BASED IN OR AROUND BOSTON AREA. .Kymanox is looking for an experienced Senior level- Technical Project Manager with experience in the Life Sciences - Biologics industry to join our team who is based in the Boston area. The position requires experience in Project/ Program Management, Medical Device Development and Design Controls, and post commercialization of medical devices and combination products. This position is client facing and requires 2 - 3 days per week on client site. Will be responsible for managing in matrixed organization across multiple departments. Provide a wide-range of support on a portfolio of two to five projects covering a wide range of engineering, compliance, and commercialization challenges. Provide project leadership utilizing industry standard Project management tools and integrating the support of multiple engineers and experienced SMEs. Projects may include any of the following focus areas:Medical Device Development and Design ControlsCombination Product Commercialization (e.g., Biologic-Device)Process and Product DevelopmentDesign Verification and ValidationProcess Validation and Validation Planning Process Improvement and TroubleshootingTechnical Report Authorship, Review, and FormattingManufacturing Investigations and CAPA/Deviation ClosureBiologic Manufacturing Scale-Up and Technology TransferFDA 483 and Warning Letter RemediationProcess and Facility Design to Support Next Gen Drug ManufacturingData Analysis, Including Statistical AnalysisQuality Management System SupportPerform additional responsibilities as requested or assigned.Desired Aptitude and Skill Set:Project Management in accordance with and KymanoxWorks cooperatively in a matrixed team environmentAble to lead high-profile projects with minimal supervisionExtremely detail-orientated and highly organizedManagerial (i.e., ''do things right'') and Leadership (i.e., ''do the right thing'') skillsStrong professional presence and presentation skillsExcellent written and oral English communication skillsFast learner with initial confidence tackling new materialSeasoned soft skills - high EQ and team playerAbility to motivate self and othersTackle problems proactively, not waiting for problems to grow unnecessarilyComputer and IT savvyThrive in a fast-paced, growing, and dynamic work environmentExpertly solicit and utilize subject matter expert inputValue and understand qualityUncompromised honesty and integrityEducational Background:Bachelor of Science Degree in Chemical, Biomedical, or Mechanical Engineering, or related technical discipline from an accredited institution. Advanced degree or industry certificates in project management (e.g., PMP, CAPM), six-sigma, engineering, quality, or regulatory affairs preferred but not required.Experience:7+ years of proven experience in the biopharma and/or medical device industries (i.e., Life Science) with knowledge in two or more of the following practice areas:Project Management or Program ManagementCGMP Manufacturing (Pharma, Biotech, Device)Quality EngineeringValidation (Equipment, Facility, Utility, Process, Cleaning, Method, Computer)Process Engineering, Technical Services, Manufacturing SciencesQuality Control or Analytical ScienceTechnology TransferClinical or Medical ServicesLate State Process or Product Development (Pharma, Biotech, Device)Travel: Local travel within the assigned region and surrounding areas is required. Up to 30% domestic and international travel may be required from time to time. The intent of this position is to stay local in the assigned region; however, the best project and growth opportunities may require initial travel to establish yourself and/or the firm with the client. If not located near Kymanox Headquarters, quarterly visits to RTP, North Carolina are expected.About Kymanox:Join Kymanox and tangibly help the world produce modern medicine more quickly, more affordably, and with the highest quality and safety standards possible in today''s biotechnology, pharmaceutical, and medical device industries. With a reputation of providing unparalleled professional services, and our highly collaborative team of engineering, compliance, and project management experts, Kymanox provides an outstanding opportunity for learning and career advancement.Kymanox is looking for motivated individuals ready to continue a career in the life sciences and at a higher trajectory. Kymanox provides professional services related to engineering, compliance, and project management; we service clients ranging from Fortune 100 companies to virtual start-up companies to government agencies. The company was founded in 2004 and has been growing steadily since its inception. Our corporate HQ is based in Research Triangle Park, NC, and we have offices in Boston, Chicago, and New Jersey.

Created: 2026-03-07