Senior Director, R&D Engineering, Endotronix

Edwards Lifesciences is growing and our Senior Director, R&D Engineering, Endotronix position is a unique career opportunity that could be your next step towards an exciting future. This role will sit within the Endotronix team, who develop implantable heart monitoring technology. Endotronix was acquired by Edwards in July 2024, and will support our future work with heart failure management solutions to address large unmet structural heart patient needs and support sustainable long-term growth.

For more details on the acquisition, please visit: https://www.edwards.com/newsroom/news/2024-07-24-edwards-lifesciences-expands-structural-heart-port

How you will make an impact:

Through vision, collaboration, and cross-functional engagement, you will lead all aspects of product development activities including MEMS sensor design, mechanical design, and electrical hardware, development to ensure effective development of new products. You will foster creative and accountable application of professional knowledge, skills, and experience in implementing product improvements and innovations that match the strategic goals of the organization. In this role you will have the opportunity to drive device improvements that meaningfully impact patient lives and the care they receive. We wear many hats so you already know how to work fluidly on cross-functional teams while also participating in hands-on engineering work. Your responsibilities will include:

• Manage all engineering aspects of the product life cycle including design changes, product enhancements, and component obsolescence management.
• Develop and implement strategic plans and product roadmaps that align with company objectives.
• Provide regular updates on product issues, assigned KPIs, and technical initiatives to upper management on an ongoing basis.
• Hire, train, coach and review the work of a team of hardware, mechanical, and electrical engineers.
• Monitor and evaluate product performance and continuously improve all product component technologies to improve overall product performance and end user experience.
• Provide strategic direction, insights, and decisions governing team and project priorities based on business needs, risks, and corporate goals.
• Ensure proper design documentation and adherence to QMS for design documentation and processes.
• Support in the preparation of regulatory documentation filings, including necessary design documentation and V&V reports.
• Lead team in root cause investigations and corrective and preventative actions. Implement risk management processes and tools and mitigate risks.
• Collect, interpret, analyze, and present field performance data including impact on device performance and develop data-backed solutions.
• Hire and lead/direct the work of other employees including performance management.

What you'll need (Required):

• Bachelor's Degree in related field; related experience in engineering and skill levels exceeding the requirements of the previous level required; and
• Demonstrated track record in management of technical and/or engineering disciplines required; and
• Experience working in a regulated industry preferred

What else we look for (Preferred): <