Biomedical Engineer Jobs in Norwalk, CT (NOW HIRING)

Prestige Consumer Healthcare is a company that focuses on product innovation and quality in the over-the-counter healthcare and women’s health categories to better improve the lives of our customers and their world. For generations, our trusted brands have helped consumers care for themselves and their loved ones. We are one of the largest independent providers of over-the-counter products in North America, and we are constantly improving and creating products that match the ever-changing lifestyles and needs of people and families everywhere.
JOB SUMMARY:
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.
MAJOR RESPONSIBILITES/ACTIVTIES:

• 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

QUALIFICATIONS:          
Required:

• MS or PhD degree in Biomedical Engineering, Mechanical Engineering (biomechanics focus), Biomechanics, Bioengineering, or related field required
• Excellent communication and presentation skills with ability to influence technical and non-technical stakeholders
• 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

Highly preferred:

• 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
• Familiarity with human anthropometry, population biomechanics data, and ergonomic design principles for consumer medical devices
• Experience co-developing substantiated consumer and regulatory claims with Marketing and supporting review with Regulatory and Legal

Not required but one or more of the following will strongly enhance resume:

• Demonstrated ability to operate independently as technical authority while leading cross-functional teams toward shared goals
• Experience defining performance requirements, human factors criteria, and validation strategies for wearable, skin-contact, or applicator-based devices
• 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)
• Extensive experience collaborating with global CDMOs and third-party partners to translate technical requirements into manufacturable solutions
• Ability to read and interpret patents and support freedom-to-operate and IP strategy in collaboration with Legal and outside counsel
• 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

Travel:
Travel up to 15%.
LANGUAGE SKILLS:
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.
MATHEMATICAL SKILLS:
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.
REASONING ABILITY:
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.
PHYSICAL DEMANDS:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to sit. The employee frequently is required to talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, and ability to adjust focus.
WORK ENVIRONMENT:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate.
No Sponsorship: Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
#HybridWork: We follow a Hybrid work schedule. All applicants must be able to work in our Tarrytown office Tues/Wed/Thurs (remote on Mon/Fri).
Work Hours: 40 hours per week.
Compensation Range: $120,000.00 - $140,000.00 Annually
 

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