Product Development Engineer

Wyss Geneva; Genf; Vor Ort; CHF 110.000 - 150.000; Vollzeit

Zusammenfassung

The Wyss Center for Bio and Neuroengineering in Geneva, Switzerland, is hiring a Product Development Engineer - Mechanical & Materials to lead engineering development for a cutting-edge medical technology program. You will translate research concepts into regulated product designs, establish verification/validation plans, and guide materials selection and qualification for patient-contact devices.

The role requires hands-on hardware development, rigorous documentation, and collaboration across

Qualifikationen

• Bachelor's degree in Mechanical engineering or related discipline.
• Minimum 5 years developing regulated medical devices.
• Experience leading development from concept through verification and validation.
• Strong materials selection, characterization and qualification expertise.
• Experience with ISO60601-1 and ISO13485 quality systems.
• Proven ability to manage cross-functional teams and communicate effectively.

Aufgaben

• Lead mechanical design and materials engineering for a novel medical device platform.
• Define product requirements, specifications and development plans.
• Drive concept generation, prototyping, testing, design reviews and optimization.
• Select and qualify materials suitable for patient-contact devices.
• Develop verification and validation strategies, protocols and reports.
• Collaborate with engineering, quality, regulatory, clinical and manufacturing teams.
• Manage external suppliers, testing labs and manufacturing partners.
• Support sterilization, packaging, shelf-life, manufacturability and lifecycle activities.
• Drive design transfer and industrialization activities.
• Contribute to intellectual property generation and startup spinout planning.

Kenntnisse

Regulated medical device development

ISO 60601-1 compliance

ISO 13485 quality systems

Project management

Technical communication

English fluency

Ausbildung

Bachelor's degree in Mechanical Engineering

Jobbeschreibung

About the Wyss Center for Bio and Neuroengineering, Geneva, Switzerland

The Wyss Center is an independent not-for-profit translational R&D organization focused on advancing disruptive neurotechnologies to transform the lives of people with neurological and mental health disorders. The Center pursues transformational technologies in artificial intelligence, bio- and neuroengineering to restore essential neural functions and deliver precision therapeutics for people with debilitating neurological and mental health disorders.

Based at Campus Biotech in Geneva, Switzerland, the Wyss Center partners with faculty, clinicians and industry, in Switzerland and internationally, to drive innovation and maximize clinical impact. The Wyss Center was established by a generous donation from the Swiss entrepreneur and philanthropist Hansjörg Wyss in 2014.

About the NeuroGI Program

NeuroGI is a Wyss Center research program exploring the connection between gut and brain health. Disorders of gut-brain interaction, such as irritable bowel syndrome, affect a large share of the population, yet there's still no direct method to monitor how the gut's own nervous system is functioning or how it changes with disease. NeuroGI combines neuroscience, imaging, and engineering to address this gap: the team has developed a miniature endoscope for recording electrical activity in the gut alongside imaging techniques that map the underlying tissue in fine detail. The program is now advancing toward a first prototype for human use, aiming to improve diagnosis of gut-brain disorders.

About the Position

The Product Development Engineer - Mechanical & Materials will lead key aspects of engineering development for an innovative medical technology program. The position spans concept development, prototyping, verification, validation, risk management, design transfer and manufacturing readiness for the NeuroGI program. The Wyss Center's model is translational by design: as NeuroGI advances toward clinical and commercial readiness, the intention is to spin the program out into an independent company, in the pattern of the Center's recent ventures. This role is expected to transition with the technology — starting as an in-house Wyss Center engineer and growing into a founding engineering position at the spin-out, with the scope for equity participation to be defined as the venture is structured.

The ideal candidate combines strong mechanical engineering skills with deep materials science expertise and a demonstrated track record of bringing regulated medical products through development, verification and validation, and into manufacturing. They combine hands-on hardware development expertise with systems-level thinking, rigorous documentation practices and the ability the ability to translate designs from research to a regulated medical device development environment.

Key responsibilities

• Lead the mechanical design and materials engineering aspects of a novel medical device platform.
• Define product requirements, engineering specifications, and development plans.
• Drive concept generation, prototyping, testing, design reviews, and iterative product optimization.
• Select, characterize, and qualify materials suitable for medical applications with patient-contact medical devices.
• Develop and execute design verification and validation strategies, protocols, and reports.
• Collaborate with multidisciplinary engineering, quality, regulatory, clinical, and manufacturing teams.
• Manage external suppliers, development partners, testing laboratories, and manufacturing vendors.
• Support sterilization, packaging, shelf-life, manufacturability, biocompatibility, and product lifecycle activities.
• Drive design transfer and industrialization activities.
• Contribute to intellectual property generation and startup spinout planning.

Profile required

• Minimum of bachelor's degree in Mechanical engineering, Materials Science, Biomedical Engineering, or related discipline.
• Minimum 5 years of experience developing regulated medical devices.
• Proven experience leading development projects from concept through verification and validation.
• Strong expertise in materials selection, characterization, and qualification.
• Experience developing systems in compliance with ISO60601-1.
• Experience working under ISO 13485 quality systems and design controls.
• Experience with prototyping, testing, failure analysis, and product optimization.
• Strong project management and communication skills.
• Contribute to intellectual property generation and startup spinout planning.
• Fluent in spoken and written English language.

Additional competence:

• Experience with catheters, implantable, minimally invasive, wearable, body-contact, or advanced medical technologies.
• Experience with Class II and/or Class III medical devices.
• Knowledge of sterilization, packaging validation, shelf-life studies, and transport testing.
• Familiarity with MDR and/or FDA regulatory pathways.
• Startup or technology transfer experience.