Manager, R&D Sustaining Engineering

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.

How you will make an impact:

Using technical acumen, collaboration, and cross-functional engagement, this role will drive sustaining engineering activities including corrective and preventative actions in response to field issues, proactive product monitoring, procedural improvements, and regulatory compliance. The ideal candidate would be adept at working in cross-functional teams, managing engineering team members while also capable of hands-on engineering work. This role will identify and resolve product issues, monitor product performance, implement product improvements that eliminate repeat issues, drive product reliability, and enhance the end user experience. Responsibilities include project/product and sustaining engineering leadership throughout the product lifecycle, driving process and product improvements and upholding compliance to Quality Management system. 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):

• Bachelor's Degree in 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

What else we look for (Preferred):

• 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

• Primarily interacts with internal subordinates and other supervisors

• Typically interacts with external suppliers, vendors and/or customers

• Share information and provides basic problem solving solutions; gains cooperation of others, conducts presentations of technical information concerning specific projects or schedules

• 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

• 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