Company Description

Join an innovative medical device company, developing the only mitral annuloplasty ring that mimics the surgical gold standard and deliver it in a fully percutaneous approach. The AMEND™ Trans Septal System is designed to treat mitral regurgitation, with the promise to become the cornerstone of any mitral intervention, leaving the option for additional therapies and potential to have early interventions. The company is currently in a clinical stage, managing multiple clinical studies in parallel to ongoing product development for further improvements towards the commercialization configuration, pivotal study, and regulatory approval. This is a great opportunity to join a pioneering, passionate, and dedicated team striving to advance healthcare technology and make a real impact on patient care! 🫀

Role Description

We are seeking a highly skilled and experienced V&V Engineer to join our team. In this role, you will play a key part in ensuring the safety and effectiveness of our medical devices throughout the product development lifecycle, leading the verification and validation activities, and be responsible for generating the technical regulatory file for PMA application for a class 3 medical device 🚀.

🔑 Key Responsibilities

• Plan, execute, and document V&V testing for medical devices, ensuring compliance with regulatory standards.
• Collaborate with cross-functional teams to define and implement test protocols, risk management strategies, and regulatory submissions.
• Manage biocompatibility testing, ETO sterilization validation, and other critical validation activities.
• Oversee the preparation of 510(k) and PMA submissions.
• Contribute to the continuous improvement of V&V protocols, reports, processes, and tools to enhance the quality and efficiency of the testing lifecycle.
• Ensure compliance with FDA, ISO, CE, and other medical device regulations throughout the product development process.

✅Experience & Qualifications

• Minimum 5 years of experience in V&V within the medical device industry.
• Solid experience with V&V testing, test method validation, and risk management processes.
• Strong understanding of medical device regulations, including FDA, ISO, and CE standards.
• Proven expertise in biocompatibility testing, ETO sterilization validation, and handling regulatory submissions (510(k), EFS).
• Experience in preparing and supporting FDA regulatory submissions and compliance activities.

⚙️Skills & Abilities

• Strong problem-solving skills with the ability to think critically and systematically.
• Excellent communication skills, both written and verbal, with the ability to present technical information clearly.
• Detail-oriented with the ability to manage multiple projects and deadlines.
• Strong organizational skills and ability to prioritize tasks in a fast-paced environment.
• Ability to work effectively both independently and as part of a collaborative, cross-functional team.
• Proactive and results-driven with a continuous improvement mindset.