Senior R&D Engineer – IVD Medical Device

Role Overview

We are seeking an experienced Engineer to lead design and development activities for our technology platform. Our technology platform consists of a single-use cartridge containing a proprietary assay combined with an optical reader for quantitative analysis. This role is ideal for a proactive problem solver who thrives in a structured engineering environment and can translate ideas into robust, compliant solutions. You will play a key role in design control, risk management, usability engineering, and product documentation.

Your key tasks will include:

• Key driver of design and development activities for the diagnostic platform, for the development of the injection moulded cartridge.
• Drive root cause analysis, FMEA, design reviews, and technical documentation.
• Support design verification through structured testing and documentation.
• Work closely with suppliers to ensure quality and timely delivery.

Qualifications

• Bachelor’s degree in engineering or natural sciences.
• Minimum 3 years of experience working in industry with medical devices or in vitro diagnostics.

Skills & Experience

• Experience with engineering verification and validation methodologies in product development cycles.
• Familiarity with ISO 13485 and working within a certified quality management system.

Ideal Candidate Profile

• Proactive and able to operate efficiently in a fast-paced startup environment.
• Strong analytical skills and attention to detail in documentation and compliance.

What We Offer

• Opportunities to tackle complex engineering challenges with mentorship and team support.
• The chance to bring your ideas to life as they enter production, scale-up, and beyond.
• A dynamic, innovative environment with room for professional growth.