Edwards Lifesciences is growing and our Director, 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, this role will lead all aspects of sustaining engineering activities including corrective and preventative activities, design and process changes, quality improvements, regulatory compliance, and cost optimization. It will foster creative and accountable application of professional knowledge, skills, and experience in sustaining products and implementing improvements that match the strategic goals of the organization. In this role you will have the opportunity to drive device improvements and manage engineering team members. The ideal candidate would be well-versed with 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 for sustaining engineering activities that align with over company objectives.

Provide regular updates on product issues, assigned KPIs, and technical initiatives to upper management on an ongoing basis.

Strengthen and expand engineering technical services through process improvement.

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.

Other incidental duties

What you'll need (Required):

Education and Experience:

Bachelor's Degree in engineering or a related field; 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):

Experience managing cross-functional engineering teams, including software, mechanical, and electrical disciplines.

At least 5 years of experience managing direct reports

In-depth knowledge of mechanical design, electrical engineering, and software engineering principles and practices

Relevant practical experience and expertise in Class II or Class III medical device development is highly desired. Experience in medical products with both hardware and software is preferred.

Project management experience required.

Knowledge and understanding of relevant medical device regulations (21 CFR Part 820), and standards (ISO 13485, IEC 62304) and experience with FDA submissions for product approvals.

Problem solving and analysis

Clear and effective verbal and written communication skills

Ability to establish relationships quickly with a broad range of constituents. Must possess a collaborative style to work effectively throughout the organization.

Hands-on leader - Ability to lead teams while also participating in design/development

Support and solicit input from team members at all levels

Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

For Illinois (IL), the base pay range for this position is $156,000 to $221,000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.   

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

COVID Vaccination Requirement

Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.