Ophthalmic New Product Development Engineer

About the Role: We are looking for an Ophthalmic New Product Development Engineer to join our team. In this role, you will be responsible for leading the development of innovative ophthalmic medical devices from early-stage concept through to preclinical testing, clinical evaluation, and market launch. You will translate clinical needs into product concepts, drive design and development activities, coordinate verification and validation testing, and support regulatory submissions and manufacturing scale-up. You will join a vibrant and fast-paced startup environment where speed in hitting the milestones with the greatest efficiency is the currency.

This role will be located at our facility in Elkton, Maryland.

Pay and Benefits:

• $90,000- $100,000 per year
• Factors considered in extending an offer within this pay range include (but not limited to) education, experience, knowledge, skills, and abilities.
• Medical, Dental and Vision benefits effective on Day 1 of employment! We offer a comprehensive total rewards package, including competitive benefits. More details are available at www.gore.com/careers/benefits

Responsibilities:

• Design, prototype, and iterate device solutions using appropriate engineering principles and design controls
• Plan and execute bench testing, preclinical studies, and clinical trial preparation to support product development milestones
• Develop and manage detailed documentation including design history files, risk assessments, test protocols, and reports in accordance with regulatory requirements (e.g., FDA, ISO 13485)
• Collaborate with regulatory, quality, clinical, and manufacturing teams to ensure smooth progression through the development pipeline
• Support technology transfer, pilot builds, and design for manufacturability activities to enable scale-up and commercialization
• Work in a fast-paced, collaborative environment that values innovation, initiative, and hands-on problem-solving

Required Qualifications:

• Minimum of a Bachelor's Degree in Engineering
• Experience manufacturing or testing devices intended for clinical trials
• Experience working on ophthalmic medical devices
• Experience working in a start-up environment, whether that is an external start-up or Internal Ventures/iCOE
• Demonstrated ability to quickly learn a new subject matter area and then efficiently deliver business results
• Ability to work independently and collaborate effectively as part of a team
• Ability to travel periodically up to 20%

Desired Qualifications:

• Experience working in a Medical Device environment and familiar with medical device regulations and standards e.g., QSR 21 CFR 820, ISO 13485
• Experience creating and maintaining a marketing booth

What We Offer: Our success is based on the capability and creativity of our Associates, and we are proud to offer a comprehensive and competitive total rewards program that supports your everyday and helps you build your tomorrow.

We provide benefits that offer choice and flexibility and promote overall well-being. And in keeping with our belief that every Associate should share in the collective success of the enterprise; we provide a distinctive Associate Stock Ownership Plan in each country as well as potential opportunities for "profit-sharing". Learn more at gore.com/careers/benefits

We believe in the strength of a diverse and inclusive workplace. With diverse perspectives, ideas and experiences, we uncover new possibilities and make a greater impact in the world. We are proud of Associates for building on our rich history of innovation, upholding our values and supporting an inclusive work environment where we treat each other and our external partners with fairness, dignity and respect.

Gore is an equal opportunity employer. We welcome all applications irrespective of race, color, religion, sex, gender, national origin, ancestry, age, status as a qualified individual with a disability, genetic information, pregnancy status, medical condition, marital status, sexual orientation, status as a covered veteran, gender identity and expression, and any other characteristic protected by applicable laws and regulations.

Gore is committed to a drug-free workplace. All employment is contingent upon successful completion of drug and background screening. Gore will consider qualified applicants with criminal histories, e.g., arrest and conviction records, in a manner consistent with the requirements of applicable laws.

Gore requires all applicants to be eligible to work within the U.S. Gore generally will not sponsor visas unless otherwise noted on the position description.

Our Talent Acquisition Team welcomes your questions atgore.com/careers/contact