Sr. Biomedical Engineer

About the role

The Senior Biomedical Engineer will work in Prestige Brands' corporate headquarters in Tarrytown, NY, focusing on new product development and R&D for various OTC medical device brands including Breathe Right, oral care, eye care, women's health, dermatology, digestive health, and respiratory brands.

Responsibilities

• Serve as R&D technical lead for the Breathe Right brand and provide biomechanics and human factors expertise across Prestige's OTC medical device portfolio
• Co-ideate new claims and indications with Marketing, providing scientific justification and validation strategies in collaboration with Regulatory and Legal teams
• Develop validation and verification protocols including benchtop testing, wear studies, clinical endpoints, and objective measurement techniques
• Participate in cross-functional teams from concept ideation through development, validation, and commercialization, acting as the technical authority in R&D for device performance, mechanism of action, and scientific substantiation
• Define biomechanical performance requirements, human factors design criteria, and test methods for new and existing medical devices, ensuring alignment with regulatory standards
• Collaborate with external partners, adhesive suppliers, converters, and manufacturers to evaluate adhesive technologies, define performance requirements, troubleshoot adhesion-related issues, and support material selection, scale-up, and commercialization
• Maintain strong technical partnerships with global CDMOs and third-party manufacturers, providing biomechanical specifications, performance standards, and scientific guidance
• Provide R&D leadership on patent strategy by conducting preliminary freedom-to-operate assessments, reading and interpreting relevant patents, and collaborating with Legal and patent counsel
• Create and maintain technical documentation in collaboration with Quality and Regulatory, including design history files, validation reports, test specifications, and biomechanical justification for regulatory submissions
• Document and communicate project progress, technical findings, and innovation strategies to senior leadership and cross-functional stakeholders

Requirements

• MS or PhD degree in Biomedical Engineering, Mechanical Engineering (biomechanics focus), Biomechanics, Bioengineering, or related field required
• 8+ years of post-degree industry experience for MS candidates, or 5+ years of post-PhD industry experience for PhD candidates, in medical device R&D
• Demonstrated expertise in biomechanics, human factors engineering, and medical device performance
• Proven experience developing and commercializing Class I and/or Class II medical devices, preferably in OTC consumer healthcare categories
• Track record leading multiple medical device programs from concept through commercialization in a cross-functional environment
• Proficiency in computational analysis techniques such as CFD and/or FEA using commercial modeling tools
• Experience defining performance requirements, human factors criteria, and validation strategies for wearable, skin-contact, or applicator-based devices
• Familiarity with human anthropometry, population biomechanics data, and ergonomic design principles for consumer medical devices
• Demonstrated success designing and executing verification and validation studies to support device performance and claims substantiation
• Strong working knowledge of FDA regulatory pathways including 510(k), design controls, risk management, and biocompatibility requirements
• Extensive experience collaborating with global CDMOs and third-party partners to translate technical requirements into manufacturable solutions
• Experience co-developing substantiated consumer and regulatory claims with Marketing and supporting review with Regulatory and Legal
• Ability to read and interpret patents and support freedom-to-operate and IP strategy in collaboration with Legal and outside counsel
• Excellent communication and presentation skills with ability to influence technical and non-technical stakeholders
• Demonstrated ability to operate independently as technical authority while leading cross-functional teams toward shared goals
• Excellent scientific communication and presentation skills with ability to convey complex biomechanical concepts to non-technical stakeholders
• Strong business judgment with ability to balance scientific rigor, speed-to-market, cost, and commercial priorities

Qualifications

• Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations
• Ability to write reports, business correspondence, and procedure manuals
• Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public
• Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume
• Ability to apply concepts of basic algebra and geometry
• Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form
• Ability to deal with problems involving several concrete variables in standardized situations