R&D Engineer – Ophthalmic Medical Devices (Concept to Market)

BVI Medical; Brielle; On-site; EUR 70,000 - 100,000; Full time

Job summary

BVI Medical seeks an on-site R&D Engineer in Vierpolders, Netherlands, to advance consumable ophthalmic devices from concept to commercialization. You will work with cross-functional teams and clinicians, adhere to design controls and QMS, and ensure regulatory compliance (ISO 13485, FDA, EU MDR).

Ideal candidates have a mechanical/biomedical engineering background, 5+ years in medical devices, and fluency in Dutch and English. Willingness to travel up to 10% is required.

Qualifications

• Bachelor's degree in Mechanical/Biomedical Engineering or related field.

Responsibilities

• Coordinate with Marketing and R&D to define market needs and business plans.
• Specify design requirements with cross-functional teams and clinicians.
• Provide technical and project leadership across complex design and development.
• Guide projects from concept to commercialization while complying with design controls/regulatory requirements.
• Define product specs, inputs, design, verification, validation studies.
• Perform engineering analyses to support new and existing designs.
• Collaborate with manufacturing partners to build robust products.
• Ensure budgets and schedules are planned and followed.
• Communicate activity status and mitigation plans to stakeholders.

Skills

Cross-functional collaboration

Regulatory awareness

Leadership

Project management

Education

Bachelor's degree in Mechanical Engineering

Bachelor's degree in Biomedical Engineering

Tools

QMS

Job description

BVI Medical seeks an on-site R&D Engineer in Vierpolders, Netherlands, to advance consumable ophthalmic devices from concept to commercialization. You will work with cross-functional teams and clinicians, adhere to design controls and QMS, and ensure regulatory compliance (ISO 13485, FDA, EU MDR).

Ideal candidates have a mechanical/biomedical engineering background, 5+ years in medical devices, and fluency in Dutch and English. Willingness to travel up to 10% is required.