Product Development Engineer (MedTech)

Join Our Client’s Mission to Revolutionize Spine Sports Medicine!

Our client is on a mission to pioneer a new category in Spine Sports Medicine. Their goal? To enhance patient care and delay the need for spinal fusion surgeries by introducing motion-preserving stabilization techniques that promote faster recovery and less invasive solutions. As a spin-off from distinguished institutions, this well-funded startup boasts a strong network of experienced partners and is poised to innovate spinal disorder management.

For their office in Zürich, our client is seeking a motivated, innovative, and creative:

Product Development Engineer

Your Responsibilities:

• Innovative Product Development: Design and develop disruptive spine instruments and implants, adhering to ISO 13485, FDA, and CE/MDR regulations.

• Cross-Functional Collaboration: Engage with quality engineering, regulatory, supplier engineering, manufacturing, clinical, and product management teams.

• Customer-Centric Design: Define design goals and specifications based on validated user needs in collaboration with product managers and project leaders.

• Technical Leadership: Lead technical initiatives with external partners (CROs, CMOs, design service providers, process development experts, etc.).

• Regulatory Contribution: Support the preparation of technical documentation and risk assessments, including FMEA, hazard analysis, and risk management processes.

Your Qualifications:

• Master’s or Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or Material Science.

• Ideally 5+ years of experience in successful product development within the medical technology field.

• Strong creativity and a track record of generating intellectual property.

• Experience in Sports Medicine (ideally spine shoulder or knee).

• Expertise in materials and manufacturing processes (e.g., injection molding, reshaping, forming).

• Knowledge of synthetic bands and fibers (ACL, shoulder, Achilles, etc.) is a plus.

• Familiarity with FDA regulations and a must-have: experience with ISO 13485 and ISO 14971.

• Motivated, independent, yet team-oriented work style with excellent communication skills.

• A proactive, problem-solving mindset, combined with a learning and agile approach.

What Our Client Offers:

• The opportunity to make a tangible impact by bringing Sports Medicine innovation to Spine.

• Be part of a cutting-edge medical ecosystem in Zürich, collaborating with renowned institutions.

• A chance to grow and develop within a dynamic, motivated, and innovative team.

• Work on groundbreaking engineering projects in a highly innovative medical device environment.

• A hybrid work setup, with the opportunity to collaborate closely with the team in a supportive and engaging office environment.

• Rellocation support.

Join our client in reshaping the future of Spine Sports Medicine! Interested? Please apply. In case of questions, please send a message to rene.lehmann@smart-recruiting.ch