Manager, R&D Sustaining Engineering

About the position

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 not just transforming patient care but also creating a unique and exciting environment for our team members. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

Responsibilities

• 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.

Requirements

• Bachelor's Degree in related field with related experience in engineering.
• Relevant experience in product development and/or sustaining engineering.
• Thorough understanding of medical device design and development standards and quality management systems.

Nice-to-haves

• Experience in class II and/or class III devices strongly preferred.
• Demonstrated ability to work autonomously and collaboratively within dynamic team environments, effectively managing shifting requirements and priorities.
• Proficient in computer skills, including MS Office, Google applications, query tools, database systems.
• Excellent written and verbal communication skills, with the capacity to articulate, present, and document complex technical concepts and issues effectively.
• Solution-oriented and professional demeanor in all interactions with colleagues and customers.
• Ability to manage technical and/or engineering disciplines and demonstrated informal mentoring and/or peer leadership skills.
• Proven successful project management skills.
• Excellent problem-solving, organizational, analytical and critical thinking skills including high discretion/judgment in decision making.
• Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives.
• Extensive understanding of engineering procedures while defining team operating standards.
• Extensive understanding of related aspects of engineering processes and/or systems.
• Demonstrated skill set to manage small team and provide coaching and feedback, including responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee relations.
• Ability to influence cross-functional partners.
• Ability to integrate metrics into the projects and operations.
• Strict attention to detail.
• Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization.
• Dedicated to quality client service and pro-active and responsive to client needs.
• Develop peer, cross functional and cross business relationships to maximize best practice sharing and team effectiveness.

Benefits

• Competitive salaries
• Performance-based incentives
• A wide variety of benefits programs to address the diverse individual needs of our employees and their families.