Lead R&D Engineer
 Hollister Incorporated | |
life insurance, paid time off, paid holidays, sick time, 401(k)
| |
 United States, Illinois, Libertyville | |
| 2000 Hollister Drive (Show on map) | |
 Oct 27, 2026 | |
|
We Make Life More Rewarding and Dignified Location: Libertyville Summary Hollister Incorporated is an independent, employee-owned company that develops, manufactures and markets healthcare products and services worldwide. Hollister dedicates itself to being a company that looks outward to the needs of healthcare professionals and the people they serve. This dedication is based on our Mission: To help healthcare professionals deliver better products and services, and to make life more rewarding and dignified for those who use our products. The Global Research & Development (R&D) organization contributes to the achievement of the Mission and our Corporate Objectives through the successful commercialization of customer-preferred new products. The Lead R&D Engineer is a member of the Hollister Ostomy New Product Development team and serves as a concept-to-commercialization technical leader. This role translates ambiguous, unmet needs expressed by clinicians and people living with ostomies into clearly defined opportunities, viable product concepts, and development strategies that deliver meaningful customer and business value. The successful candidate will have demonstrated experience leading medical device products from early discovery and concept development through design transfer and commercial launch. The Lead R&D Engineer is accountable for reducing uncertainty during early development, generating and evaluating multiple solution concepts, and making evidence-based trade-off decisions among user desirability, technical feasibility, manufacturability, quality, regulatory, cost, schedule, and portfolio considerations. The role leads cross-functional development activities under an ISO 13485-compliant quality management system and applies design controls, risk management, usability engineering, verification, validation, design transfer, and structured problem solving with minimal supervision. This position will be required to be onsite at minimum, 4 days a week, at the Libertyville, IL office. Responsibilities Lead discovery with clinicians and people living with ostomies using interviews, observation, contextual inquiry, and concept evaluation to uncover explicit and latent needs. Synthesize ambiguous input into prioritized user needs, opportunity statements, design criteria, and product requirements. * Independently frame and execute complex, open-ended technical work in which the problem, solution, or requirements are not yet fully defined. * Provide technical leadership to cross-functional project teams from opportunity definition through commercial launch. Facilitate scenario planning and timely trade-off decisions, document technical rationale, and align stakeholders when customer, technical, manufacturing, quality, cost, and schedule requirements compete. * Demonstrate advanced proficiency in end-to-end medical device development, including Stage Gate, design controls within an ISO 13485-compliant quality management system, ISO 14971 risk management, usability engineering, design of experiments (DOE), verification, validation, design transfer, and structured problem solving. * Apply business and portfolio judgment to assess customer value, commercial potential, technical risk, development investment, and impact on current and future products. * Use sketches, physical models, CAD software (e.g., SolidWorks), and other rapid-learning methods to communicate, prototype, and evaluate alternative product concepts. CAD proficiency is important, but this role is primarily responsible for concept creation and technical leadership rather than detailed design execution alone. * Create detailed engineering specifications and drawings. * Plan iterative prototype-build-test-learn cycles to evaluate critical assumptions, compare concepts, establish feasibility, and improve the product definition before detailed design. * Lead feasibility studies, technical risk reduction, and concept selection using objective evidence to confirm that proposed solutions can meet user, performance, regulatory, safety, manufacturing, and business requirements. * Develop and conduct testing protocols to verify and validate device performance against design inputs and user needs. * Conduct analysis of data and develop detailed reports documenting results, conclusions, and recommendations * Partner early and continuously with manufacturing, global engineering, operations, suppliers, and quality to define scalable processes, assess capability, manage design-for-manufacture and assembly trade-offs, and support design transfer and launch readiness. * Own or author technical documentation required by the design control process, including design and development plans, user needs, design inputs, concept-selection rationale, risk-management outputs, verification and validation evidence, design reviews, traceability, and design-transfer deliverables. * Identify, assess, and integrate new or existing technologies, materials, and processes to create differentiated product concepts and deliver a robust commercial product. * Collaborate cross-functionally with the planning, execution, and documentation of usability engineering activities throughout the product development lifecycle. Essential Functions of the Role * Ability to work in a laboratory setting and use prototype machinery * Ability to lift 15-25kg * Ability to travel as needed to Hollister manufacturing facilities and vendor locations Education and Experience Requirements Bachelor's degree in an engineering or related technical discipline with a minimum of 8 years of medical device product-development experience, including demonstrated ownership of products from ambiguous customer need or earlyconcept through design transfer and commercial launch; OR Master's degree in an engineering or related technical discipline with a minimum of 6 years of medical device product-development experience, including demonstrated ownership of products from ambiguous customer need or early concept through design transfer and commercial launch. Specialized Skills/Technical Knowledge * Demonstrated ability to convert qualitative customer insights from interviews, observation, contextual inquiry, and concept evaluation into actionable user needs, design criteria, product requirements, and differentiated concepts. * Hands-on experience applying medical device design controls in an ISO 13485-compliant quality management system, including design history file documentation, ISO 14971 risk management, FMEA, requirements and traceability, design reviews, verification, validation, design transfer, and change control. * Required: a demonstrated record of creating product concepts from incompletely defined customer or clinical needs and advancing at least one medical device through detailed development, production scale-up or design transfer, and commercial launch. Experience limited primarily to detailed design of pre-defined concepts will not meet the core requirement of this role. * Experience as the technical leader of multidisciplinary teams, influencing without direct authority and leading decisions across marketing, clinical, design assurance, regulatory, engineering, operations, suppliers, and project management. * Advanced understanding of medical device materials, manufacturing processes, process capability, tolerance and variation, design for manufacture and assembly, supplier considerations, and equipment or process qualification. * Hands-on experience with rapid prototyping, experimental learning, and CAD modeling; ability to select the appropriate fidelity of prototype for the question being answered. * Ability to innovate, adapt quickly, and persist through challenges. * Strong verbal and written communication skills to effectively present technical information to non-technical stakeholders in English. ** To comply with regulations by the American with Disabilities Act (ADA), the principal duties in job descriptions must be essential to the job. To identify essential functions, focus on the purpose and the result of the duties rather than the manner in which they are performed. The following definition applies: a job function is essential if removal of that function would fundamentally change the job. Our Total Rewards package in aggregate is above market and includes competitive pay, paid time off programs, peer-to-peer recognition, health and life insurance, wellness programs and incentives, and generous retirement savings.
About Hollister Incorporated EOE Statement Job Req ID: 36156 | |