Director of Engineering

at  Endotronix Inc

WHO ARE WE?

Endotronix is a medical device company that aims to transform the treatment of heart failure, a chronic, progressive condition in which the heart is unable to pump enough blood to support the body. Our Cordella Heart Failure System (CHFS) includes proactive management tools for best practice care and detection of worsening heart failure. These easy-to-use tools improve patient quality of life and help to reduce hospital admissions thereby reducing health care costs. With our recent PMA approval from the FDA, we are preparing to grow our team – it’s a great time to join Endotronix!
The Director of Engineering leads a team of engineers and engages cross-functional teams in identifying and resolving product issues, and implementing product improvements that eliminate repeat issues, drive product quality and reliability, and enhance the end user experience. Responsibilities include team leadership and talent development, sustaining engineering support throughout the product lifecycle, project and resource planning, and developing processes and systems for effective product management after a launch. The Director of Engineering will drive process and product improvements and uphold compliance to the Quality Management System. This is an on-site position based in Naperville, Illinois.

EDUCATION

• Bachelor’s degree in engineering or related field (advanced degree preferred)

Through vision, collaboration, and cross-functional engagement, you will lead all aspects of sustaining engineering activities including corrective and preventative activities, design and process changes, quality improvements, regulatory compliance, and cost optimization. You 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 while managing engineering team members. 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 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.