Lead R&D Engineer

Lead R&D Engineer

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. The Lead R&D Engineer will lead or participate in new product development project teams to drive and develop product solutions that provide meaningful value to our customers and business, while maintaining the high level of quality Hollister products are known for. The role requires a collaborative individual who has experience being a technical leader within cross-functional teams that include colleagues from across the organization including marketing, engineering, operations, project management, and quality. The Lead R&D Engineer's main job responsibilities include concept development, design refinement, 3D modeling, design verification and validation, statistical analysis, and technical leadership. The position operates under minimal supervision for technical tasks and demonstrates a sound understanding of structured problem-solving methodology to make sound decisions in assigned work. Hollister Incorporated operates in a hybrid work environment. Employees are expected to come into the office a minimum of 4 days per week. Sponsorship to work in the US is not available at this time.

Responsibilities:

• 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.
• Provides a level of business acumen and understands 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.
• Application of 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.

Essential Functions of the Role:

• 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.

Education and Experience Requirements:

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

Specialized Skills/Technical Knowledge:

• 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, etc.)
• Advanced understanding of manufacturing processes and materials commonly used in medical device manufacturing, as well as how to qualify them.
• Hands-on experience with prototyping and CAD modeling
• 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.

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