Sr. Quality Engineer, NPD - IHFM

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.

We are looking for a strong engineer with solid technical expertise, who enjoys working in a fast-paced and rapidly growing environment where taking initiative and collaborating cross-functionally are critical for success.

The engineer will have a variety of responsibilities in New Product Development providing Quality Engineering support and leadership to ensure the successful design and development of new products.

How you will make an impact:

• Provide technical leadership for successful new product development projects by applying design control and risk management principles to positively influence new product development efforts from concept through product launch including design verification, validation, and design and manufacturing specification development.
• Partner and collaborate with cross-functional stakeholders and peers on new product development teams to align on goals and drive actions to meet commitments.
• Lead development and drive updates to risk management files for new products
• Lead test method development and validation activities for new designs
• Lead development and implementation of inspection and testing mechanism for components, sub-assemblies, and final assemblies used in new product design and manufacturing
• Develop technical solutions to complex problems, recommend and implement corrective actions, using creativity, statistical techniques, and reliability engineering
• Collaborate with manufacturing and operations team to ensure successful transfer and launch of robust products.
• Ensure compliance with all Federal, State, local and company regulations, policies and procedures.
• Performs other incidental duties as assigned by management
• Ability to travel up to 20% domestically and internationally

What you'll need (Required):

• Bachelor's Degree in Engineering or Scientific field, 4 years’ experience including either industry or industry/education or