Senior Director, R&D Engineering

Join to apply for the Senior Director, R&D Engineering role at Edwards Lifesciences.

Many structural heart patients suffer from heart failure with limited options. Our Implantable Heart Failure Management (IHFM) team is at the forefront of addressing these unmet patient needs through pioneering technology that enables early, targeted therapeutic intervention. Our innovative solutions are transforming patient care and creating an exciting environment for our team members. Join us to be part of this inspiring journey.

How you will make an impact:

Through vision, collaboration, and cross-functional engagement, you will lead all aspects of product development, including MEMS sensor design, mechanical design, and electrical hardware development, ensuring effective development of new products. You will foster creative and accountable application of your professional knowledge and experience to implement product improvements and innovations aligned with organizational goals. You will have the opportunity to drive device improvements that significantly impact patient lives and care. Your role involves working fluidly on cross-functional teams and participating in hands-on engineering work. Your responsibilities include:

1. Manage all engineering aspects of the product lifecycle, including design changes, product enhancements, and component obsolescence management.
2. Develop and implement strategic plans and product roadmaps aligned with company objectives.
3. Provide regular updates on product issues, KPIs, and technical initiatives to upper management.
4. Hire, train, coach, and review hardware, mechanical, and electrical engineering teams.
5. Monitor and evaluate product performance, continually improving technologies to enhance overall performance and user experience.
6. Provide strategic direction and decisions on team and project priorities based on business needs and risks.
7. Ensure proper design documentation and compliance with QMS processes.
8. Assist in preparing regulatory documentation, including design files and V&V reports.
9. Lead root cause investigations, corrective actions, and risk management processes.
10. Analyze field performance data to develop data-backed solutions.
11. Hire and lead team members, managing performance and development.

What you'll need (Required):

• Bachelor's Degree in a related field with relevant experience exceeding previous level requirements.
• Proven track record in managing technical or engineering disciplines.
• Experience in a regulated industry is preferred.

What else we look for (Preferred):

• Extensive engineering experience, especially in medical device development, with a focus on implantable sensors for cardiac monitoring.
• Experience managing cross-functional engineering teams and implementing global enterprise systems.
• Strong communication skills, both verbal and written.
• Deep knowledge of MEMS sensors, mechanical and electrical engineering principles.
• Understanding of medical device regulations (21 CFR Part 820, ISO 13485, IEC 62304) and FDA submission experience.
• Hands-on leadership style, capable of participating in design and development.
• Ability to build relationships across organizational levels and work collaboratively.
• Experience with Class II or III medical devices, hardware/software integration preferred.
• Proven project management skills.
• Proficiency in Microsoft Office and related systems.
• Excellent problem-solving, organizational, and analytical skills, with high discretion in decision-making.
• Strong documentation, interpersonal, and negotiation skills.
• Expertise in engineering procedures and resolving complex problems.
• Financial acumen related to engineering and business.
• Ability to lead, coach, and manage employee performance.
• Skill in developing and using metrics to demonstrate engineering value.
• Ability to influence senior leadership and develop cross-functional relationships.
• Attention to detail and professional interaction skills.
• Ability to thrive in a fast-paced, dynamic environment.
• Experience in engaging with senior management and external stakeholders.
• Ability to conduct briefings and influence decisions at high levels.
• Commitment to quality client service and proactive communication.
• Ability to foster teamwork and leverage organizational relationships to drive change.
• Adherence to company rules, safety, and environmental protocols.

We offer competitive salaries, performance incentives, and benefits to meet diverse needs. The base pay range for Illinois is $187,000 to $265,000, depending on experience and qualifications. Applications are accepted while the position is posted. Edwards is an Equal Opportunity Employer, including protected Veterans and individuals with disabilities.

COVID Vaccination Requirement

All patient-facing and in-hospital roles require COVID-19 vaccination, unless a medical or religious exemption is granted. Proof of vaccination is required upon hire where legally permitted.