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.

The Senior Quality Engineering role is a great opportunity to support the IHFM manufacturing team as we begin to set up operations in Irvine. In this role you will begin by setting up the distribution and servicing operations for one of our most recent acquisitions. Upon successful setup in Irvine, you will join the team responsible for transferring our first sensor manufacturing line to Irvine.  You will also support the IHFM team by managing engineering activities from new product introductions, stabilization, and sustaining.

How You Will Make an Impact:

• Investigating complex manufacturing product quality and compliance issues (e.g., Material Review Board, CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyzing results, making recommendations and developing reports.
• Identifying and ensuring the optimization of complex Manufacturing and/or R&D processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement. Identifying opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk. Implementing and monitor Critical Control Points. Developing, updating, and maintaining technical content of risk management files (e.g. FMEAs, Quality Control Plans).
• Developing, optimizing and validating low complexity test methods and associated equipment. Supporting documentation of inspection methods for purchased components. Collaborating with engineers for equipment selection and validation.
• Developing training and documentation materials for production and Receiving Inspection (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes.
• Implementing and approving compliant change control.
• Assigning support tasks; giving instruction to technicians on conducting tests; training technicians and providing feedback; and may coordinate technician work.

What you’ll need:

• Bachelor’s degree in Engineering or Scientific field with at least four 4 years of experience with either supplier quality, quality engineering, and/or manufacturing.
• Onsite required.
• Highly regulated industry experience.
• Must have ability to travel up to 10%.

What else we look for:

• Class II and Class III medical device manufacturing experience is preferred.
• Experience with Windchill PTC.
• Proven expertise in usage of MS Office Suite.
• Knowledge and understanding of FDA’s 21 CFR Part 820, ISO13485, ISO9001, and other International Regulatory Standards.
• Experience and/or proficient knowledge of Design Controls and test method development/validations.
• Demonstrated experience driving component testing, test method validations, and testing/validating equipment.
• Experience with statistical techniques and tools such as Gage R&R, Statistical Process Control, or Process Capability Studies.
• Ability to conduct effective root cause analysis; driving non-conformance investigations; and assessment of corrective action strategies and effectiveness as applied through CAPAs.
• Knowledge of GD&T and ability to read and interpret drawings.
• Good understanding of process validations (IQ, OQ, PQ).
• 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 California, the base pay range for this position is $108,000 to $153,000 (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.