Lead R&D Engineer

Tagline

We Make Life More Rewarding and Dignified

Libertyville
Department:
Research & Development

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.

• Collaborate with clinicians and end‑users to gain a deep understanding of their needs. Support the creation of user needs and ensure the optimization of product functionality and performance based upon their feedback.
• Independently design & execute complex technical assignments and processes supporting functional goals.
• Lead or support project teams in effective decision making, scenario planning, and strategic analysis.
• Demonstrate advanced proficiency in product development processes such as Stage Gate, design controls, risk management, design of experiments (DOEs), and structured problem solving.
• Provide a level of business acumen and understand how a project or product may impact current and future projects / product portfolio.
• Use CAD Software (i.e. Solidworks) to develop and design concepts, components, and systems which will meet customer needs.
• Create detailed engineering specifications and drawings.
• Develop prototypes and conduct hands‑on testing to evaluate the performance of the device.
• Conduct feasibility studies and risk assessments to ensure products meet performance requirements, regulatory requirements, and safety standards.
• 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.
• Collaborate with engineering to optimize the product design for efficient and cost‑effective manufacturing processes.
• Prepare technical documentation in accordance with regulatory and design control requirements.
• Apply both new and existing technologies, materials, and processes to deliver a final product.
• Collaborate cross‑functionally with the planning, execution, and documentation of usability engineering activities throughout the product development lifecycle.
• Develop and maintain strong relationships with cross‑functional team members (i.e. marketing, design assurance, global engineering, operations, project management, clinical) and ensure that products meet all necessary requirements.
• Collaborate with intellectual property (IP) team and have a basic understanding of IP.
• Support continuous improvement initiatives for the Global R&D organization and Hollister Ostomy NPD team.

• Ability to work in a laboratory setting and use prototype machinery.
• Ability to lift 15–25 kg.
• Ability to travel as needed to Hollister manufacturing facilities and vendor locations.

• Bachelor’s degree in technical discipline with 8 years minimum of related medical device experience.
• Master’s Degree in technical discipline with 6 years minimum of related medical device experience.

• Advanced understanding of best practices in interviewing, focus group facilitation, and observation to derive deeper customer insights.
• Proficiency with Design Controls including documentation of design history files (DHF), risk management files, failure mode effects analysis (FMEA), traceability matrices, and verification and validation (V&V) processes.
• Experience in designing and developing medical devices across various stages (concept, prototyping, testing, production).
• Experience as a technical leader within multidisciplinary teams (marketing, design assurance, engineering, operations, regulatory, clinical,…