Director of Engineering

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.

What You'll Do

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.
  
  

What You Bring To The Table

• 15+ years of related engineering experience, with a strong background in medical device development
• 10+ years of experience managing cross-functional engineering teams, including software, mechanical, and electrical disciplines.
• 5+ years of experience managing direct reports
• Problem solving and analysis
• Clear and effective verbal and written communication skills
• In-depth knowledge of mechanical design, electrical engineering, and software engineering principles and practices
• 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.
• Hands-on leader - Ability to lead teams while also participating in design/development
• Ability to establish relationships quickly with a broad range of constituents. Must possess a collaborative style to work effectively throughout the organization.
• 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.
  
  

EDUCATION

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

Who You Are

• Relentlessly focused on data and hypothesis driven decision making to create the best experiences for ETX patients and customers
• Someone with a bias for action and quick iteration as opposed to perfection
• A quick learner, who is able to work independently, multitask, and drive your own projects
• An effective communicator and collaborator who can synthesize insights from multiple stakeholders across business functions to deliver purpose-built insights, models and tools that provide easily interpretable and actionable results
• A team player who can inspire teams to deliver together, embodying the idea that the whole is greater than the sum of the parts
• Passionate about digital healthcare and leveraging Data to deliver innovative solutions at scale
  
  

What We’re Like

• Willing to have the “direct and honest conversation”. Not afraid to confront the facts (or be confronted) and develop a plan to move forward.
• Competitive spirit and drive to win. Strong sense of initiative, internal motivation, and an unrelenting focus on results.
• Openness to feedback and coaching with a strong orientation towards continual learning and improvement. Ability to solicit, accept and provide direct feedback without defensiveness.
• Capacity to function in a highly complex company with ease and fluidity, while driving and influencing results.
• Entrepreneurial, flexible, yet results focused.
• High degree of intellectual curiosity, honesty, and capability.
• Low ego and humble in spirit in spite of your track record of outstanding performance.
  
  

LIFE AT ENDOTRONIX

• Our shared company values create a foundation of trust and collaboration. United in a common purpose, we excel at the task at hand to provide best-in-class medical technology and customer service to our patients and clinicians. And along the way we make sure to have a little fun, continue to grow and celebrate our successes.
• We provide a competitive compensation package, comprehensive benefits including unlimited PTO, and an environment that will help you to thrive and succeed in your career.
• Endotronix is an equal opportunity employer, and we are committed to providing equal employment opportunities to all persons without regard to race, creed, color, religion, national origin, gender, marital status, citizenship status, age, veteran status, or disability. We are passionately committed to building a diverse organization where all perspectives and cultures are