Head of Operations

About MYNERVA

At MYNERVA, a project by Wyss Zurich, we are dedicated to enhancing the lives of those affected by neuropathy. Our innovative medical device aims to artificially restore the sense of touch and alleviate pain through non-invasive neurostimulation techniques.

Position Overview

We are looking for a driven individual to lead our operational framework, regulatory strategy, and quality systems as we prepare for the clinical and commercial scale of our initiatives. This important role requires a seasoned leader with a strong background in operational excellence, medical device compliance, and international market readiness, specifically in the United States.

Key Responsibilities

• Operations
  • Oversee operational planning and execution, establishing clear KPIs, timelines, and budgetary controls in collaboration with various departments.
  • Foster continuous improvement in operational workflows, cost management, and risk assessment.
• Manufacturing & Supply Chain Management
  • Build and manage scalable manufacturing operations, including supplier management, to support clinical and commercial objectives.
  • Oversee procurement processes, production planning, and inventory management to guarantee timely and quality-based deliveries.
  • Enhance logistics and global distribution strategies.
• Quality & Regulatory
  • Lead the quality team in establishing robust quality management systems in alignment with ISO 13485, FDA QSR (21 CFR 820), and applicable standards.
  • Collaborate with the CEO and regulatory team to support and execute the regulatory strategy for the US and international markets.
  • Assist in the regulatory submission process with internal stakeholders and external consultants.

Ideal Candidate Profile

• Education & Experience:
  • Bachelor's or Master's degree in Engineering, Operations, Quality, or a related discipline.
  • A minimum of 10 years in the industry, with at least 5 years in operations roles within the medical device sector.
  • Experience with US FDA regulatory pathways and product commercialization in the US market.
• Skills & Competencies:
  • Highly energetic and organized with a hands-on approach.
  • Entrepreneurial mindset with strategic thinking capabilities.
  • Deep understanding of medical device manufacturing and quality requirements.
  • Excellent execution, leadership, and organizational skills.
  • Familiarity with international regulatory frameworks (FDA, ISO 13485).
  • Knowledge of risk management, document control, and design controls.
  • Strong communication and stakeholder management skills.
  • Fluency in English is required; proficiency in German or other languages is advantageous.

Why Join Us?

• Engage in a high-impact role within a pioneering MedTech startup.
• Enjoy fast-track career advancement opportunities as MYNERVA scales its operations.
• Be part of a highly motivated and collaborative team devoted to enhancing patient well-being.
• Experience a dynamic, diverse, and innovation-driven working environment.
• Benefit from employee perks aligned with ETH Zurich's benefits program.

Our Commitment to Diversity

In line with our core values, MYNERVA promotes an inclusive culture that values diversity. We strive to create an environment where every individual’s rights and dignity are recognized and respected.

Explore Your Potential

At MYNERVA, you will be part of a team dedicated to making a difference in the lives of individuals facing neuropathy. Join us in our mission to innovate and improve healthcare solutions for patients around the globe.