Lead R&D Engineer

About the role

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.

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.
• 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.

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.
• 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.

Qualifications

• 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.

Skills

• 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.

Benefits

• 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 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.

Pay

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.

Schedule

Hollister operates in a hybrid work environment. Employees are expected to come into the office a minimum of 4 days per week.

Application Instructions

Sponsorship to work in the US is not available at this time.