Lead R&D Engineer

We Make Life More Rewarding and Dignified 

Location: ​Libertyville​
Department: ​Research & Development 

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 early concept 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.

• The anticipated base pay range for this position is $110,000 - $155,000 yearly. The actual salary varies based on applicant's location, education, experience, skills, abilities, and other legitimate business factors.​
• This position is also eligible to participate in the Hollister Corporate Bonus Plan.
• The Company’s health and welfare benefits include medical, prescription, dental, vision, spending/savings accounts, disability, company paid (parental and caregiver) leaves, statutory leaves/disability programs, accident, life, wellbeing, education assistance, adoption assistance, and voluntary benefit programs. ​
• The Company’s 401(k) Retirement Savings Plan includes: auto-enrollment, ROTH, vesting and eligible participants “safe harbor” matching contributions. ​
• The Company’s paid time off benefits include: 11 paid holidays, paid vacation based on length of service and exempt/non-exempt status, and sick days based on statutory requirements and/or exempt/non-exempt status. ​
• The Company’s additional benefits include: education assistance and adoption assistance benefit programs. 

About Hollister Incorporated
Hollister Incorporated is an independent, employee-owned company that develops, manufactures and markets healthcare products worldwide. The company spearheads the advancement of innovative products for ostomy care, continence care and critical care, and also creates educational support materials for patients and healthcare professionals. Headquartered in Libertyville, Illinois, Hollister has manufacturing and distribution centers on three continents and sells in nearly 80 countries. Hollister is a wholly owned subsidiary of The Firm of John Dickinson Schneider, Inc., and is guided both by its Mission to make life more rewarding and dignified for people who use our products and services, as well as its Vision to grow and prosper as an independent, employee-owned company, and in the process, to become better human beings.

EOE Statement
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Job Req ID: 36156