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:

The R&D Sustaining Engineer will play a crucial role in investigating field issues, working closely with manufacturing teams to implement design and process improvements, and maintaining the overall performance and quality of our devices. Key roles/responsibilities include:

• Issue Resolution: Investigate and resolve device field issues by analyzing product performance data, customer feedback, and failure reports. Use engineering principles to define studies and moderately complex lab tests (including writing and executing protocols) to identify root cause. Analyze results, make recommendations, and develop reports. Provide timely and effective solutions to minimize device downtime and customer impact.

• Design and Process Improvement: Collaborate with cross-functional teams, including R&D and manufacturing, to identify, test, and implement design changes and process improvements that enhance device reliability, performance, use, and manufacturability. Identify, evaluate, manage, and provide guidance to suppliers, including establishing tolerances and defining acceptance criteria for suppliers.

• Device Performance Monitoring: Continuously monitor and assess device performance and quality metrics. Develop and execute plans to address any deviations from established standards and ensure sustained high performance.

• Documentation and Compliance: Maintain accurate and comprehensive design control documents including requirement specs and risk documents relevant to engineering changes and investigation activities. Ensure all activities comply with regulatory requirements and company standards. Collaborate with quality and regulatory to address regulatory requests.

• Cross-Functional Collaboration: Work closely with manufacturing, quality assurance, clinical development, and regulatory teams to support product lifecycle management and ensure optimal selection and seamless integration of engineering solutions.

• Ability and willingness to travel 10% of the time

• Other duties assigned by Leadership

What you'll need (Required):

• Bachelor's Degree in Engineering or Scientific field with 2 years' experience -OR- Master's Degree or equivalent in Engineering or Scientific field with internship, senior projects, or thesis in Engineering or Scientific field including either industry or industry/education

What else we look for (Preferred):

• Medical device experience preferred, including familiarity with medical device regulations and quality standards (e.g., FDA, ISO) and CAPA process

• Good computer skills in usage of MS Office Suite; CAD experience preferred

• Solid problem-solving, organizational, analytical and critical thinking skills

• Strict attention to detail

• Basic understanding of statistical techniques

• Previous experience working with lab/industrial equipment and solid understanding of processes and equipment used in assigned work

• Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering

• Ability to manage competing priorities in a fast-paced environment

• Must be able to work in a team environment, including the ability to manage vendors and project stakeholders

• Good documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills

• Ability to interact professionally with all organizational levels and build productive internal/external working relationships

•  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 $85,000 to $120,000 (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.