Sr. Biomedical Engineer

Prestige Brands•Tarrytown, NY

2d•$120,000 - $140,000•Hybrid

About The Position

As a Senior Biomedical Engineer, you will work closely with cross-functional teams in our corporate headquarters in Tarrytown, NY focusing on new product development and R&D for the Breathe Right brand and supporting our other OTC medical device and device-adjacent portfolio spanning respiratory, oral care, eye care, women's health, dermatology, and digestive health brands. You will be a member of a cross-functional team to help take New Product Ideas from concept ideation through biomechanical validation, claims substantiation, and process qualification. Forging strong technical relationships with global 3rd party manufacturers will be critical to successfully develop and commercialize innovative medical devices. Your expertise in biomechanics, human factors engineering, and device performance will support evidence-based claims development and new product development for Class I and Class II medical devices.

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 (e.g., ANSYS, COMSOL, SolidWorks Simulation)
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 (Marketing, Legal, Regulatory, Executive leadership)
Strong business judgment with ability to balance scientific rigor, speed-to-market, cost, and commercial priorities

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 including oral care, eye care, women's health, dermatology, digestive health, and respiratory brands
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 (e.g., rhinometry, bite force analysis, ocular retention, adhesive performance) to support new claims and product launches
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 for Class I and Class II devices
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 for skin-contact and device-adjacent products
Monitor the competitive and technology landscape for emerging medical device platforms, novel materials, and adjacent product categories relevant to Prestige's OTC portfolio, translating insights into actionable innovation opportunities.
Design and execute biomechanical modeling, computational analysis (CFD, FEA), and human factors studies to optimize device performance and validate mechanisms of action for nasal dilators, oral care devices, wearables, applicators, and delivery systems
Establish strong technical partnerships with global CDMOs and third-party manufacturers, providing biomechanical specifications, performance standards, and scientific guidance to ensure successful product development and commercialization
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 to support IP clearance and patent filings for innovation projects
Build external credibility through conference presentations, peer-reviewed publications, and Key Opinion Leader (KOL) relationships with healthcare professionals to establish Prestige as an evidence-based leader in OTC medical devices
Identify and evaluate third-party research partners, testing laboratories, clinical CROs, and academic collaborators that can provide specialized biomechanical, human factors, or clinical validation capabilities
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 (510(k), design controls, risk management)
Document and communicate project progress, technical findings, and innovation strategies to senior leadership and cross-functional stakeholders