R&D Engineer - Medical Devices

Purpose We are seeking an R&D Engineer to support the development of consumable products for ophthalmic surgical devices. This full-time, on-site role based in Vierpolders, Netherlands, contributes to the development of innovative medical technologies from concept through commercialization, while ensuring compliance with applicable quality and regulatory requirements. Key Responsibilities Coordinates with Marketing and R&D in defining market and customer needs and in developing a business plan in target markets.Specify design requirements for current and future products by working closely with cross-functional team and healthcare providers.Provide technical and project leadership over complex design, and development projects.Effectively provide guidance to project teams in development of products and technologies from concept to commercialization while adhering to medical device design controls/regulatory requirements.Define product specifications, design inputs, product design, verification testing and supporting design validation studies.Perform engineering analyses to support new and existing designs.Work with internal and external manufacturing partners to build robust products.Hold self and team members accountable to meet commitments.Ensure budgets and schedules are well planned and followed.Effectively communicate activity status, issues and mitigation plans with key stakeholders. Qualification Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related field; advanced degree or MBA preferred.Minimum 5 years of relevant experience in the medical device industry, preferably with consumable products, or an equivalent combination of education, training, and experience.Experience collaborating with clinicians and Key Opinion Leaders (KOLs).Proven experience developing products from concept through commercialization.Experience working on cross-functional teams across the full product development lifecycle.Familiarity with product design and development processes and Quality Management Systems (QMS).Experience operating within a regulated design controls environment, with knowledge of ISO standards and medical device regulations (e.g., FDA, EU MDR, ISO 13485).Knowledge of cGMP and FDA/CE Mark regulatory requirements.Results-oriented with the ability to plan and deliver against project deadlines.Strong interpersonal skills with the ability to build effective working relationships across cross-functional teams.Excellent written and spoken Dutch and English.Must be able to work on-site in Vierpolders, Netherlands.Willingness to travel up to 10% as required. Company BVI® is refocusing the future of vision. As one of the fastest-growing, diversified surgical ophthalmic businesses in the world, our purpose-built portfolio of trusted brands includes: Beaver® (Knives and Blades), Visitec® (Cannulas), Malosa® (Single-Use Instruments), Vitreq® (Vitreoretinal Surgical Products) and PhysIOL® (Premium IOLs), and spans more than 90 countries. We’ve set our sights on touching the lives of millions of patients affected by conditions such as cataracts, refractive error, glaucoma, retinal disease, and dry eye. Unburdened by legacy or bureaucracy, we have developed our strategy around a simple concept – taking pride in delivering innovative solutions for our physicians and patients, based on their needs. We trust and empower our associates to make decisions and solve problems because collaboration drives us. Valuing agility, simplicity, and transparency, we stay committed to listening to our customers, delivering for our patients, and keeping the future in focus. Learn more at www.bvimedical.com