Senior Biomedical Engineer Jobs in Ladera Ranch, CA

Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient’s unmet clinical needs.It’sour driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

The Senior Engineer will serve as a technical subject matter expert, partnering closely with internal teams and external suppliers to ensure product designs meet user needs - including ease of use, manufacturability, cost effectiveness, and operational efficiency. In addition to technical engineering capabilities, this role requires strong project management capabilities and a thorough understanding of Design Control and Catalyst processes to drive effective, compliant, and timely project execution.

How you’ll make an impact:

• Lead the successful commercialization of next-generation medical devices by driving supplier development, validation, milestone builds, and manufacturing integration from concept through product launch.

• Serve as a key technical leader in NPD, partnering with R&D, Quality, Operations, Supply Chain, and external suppliers to transform innovative designs into scalable manufacturing solutions.

• Conduct reviews to ensure DFM considerations are incorporated into designs, ensuring manufacturability, quality, reliability, scalability, and cost optimization are incorporated early in the development process.

• Drive technical collaboration with strategic suppliers to develop advanced manufacturing processes, evaluate emerging technologies, and enhance product and process performance.

• Provide engineering guidance through design reviews, drawing reviews, risk assessments, and process capability evaluations to enable robust and reliable manufacturing outcomes.

• Define supplier qualification and validation strategies for OEMs, contract manufacturers, custom materials, and critical component suppliers supporting global product portfolios.

• Lead technical governance and engagement with key suppliers, driving performance, resolving complex challenges, and ensuring alignment on business-critical objectives.

• Develop innovative manufacturing technologies and production strategies to support new products, improve operational efficiency, and accelerate commercialization timelines.

• Conduct supplier assessments focused on technical capability, quality systems, capacity planning, and long-term scalability to support business growth.

• Partner with suppliers and internal teams to optimize manufacturing processes, implement automation solutions, improve yield, and drive continuous improvement initiatives.

• Champion successful technology transfers and design-to-manufacturing transitions, ensuring manufacturing readiness and sustainable production performance across global sites.

• Lead supplier risk management, capacity planning, and mitigation strategies to support uninterrupted supply and successful product launches.

• Provide technical leadership updates during supplier audits, product investigations, regulatory submissions, design changes, and post-market product enhancements.

• Manage product lifecycle activities, including design changes, supplier transitions, product phase-in/phase-out initiatives, and regulatory-driven updates.

• Influence long-term sourcing and manufacturing strategies through supplier selection, capability assessments, qualification planning, and deployment of best-in-class manufacturing practices.

What we look for:

• Bachelor's degree in engineering or scientific, with 4 years of experience in new product development, process development, commercialization, and/or operations engineering in a highly regulated environment.

• Travel up to 25% domestically and internationally.

• On-site work required.

What else we look for:

• Master’s degree in engineering and/or MBA.

• Experience in medical device new product development, including successful design optimization and progression from early development through commercialization.

• Background in at least two of the following areas: interventional access devices, rapid product development, component-level manufacturing, or complex assembly design.

• Hands‑on experience with catheter manufacturing processes, such as extrusions, braiding, molding, laser welding, and bonding techniques.

• Demonstrated capability to apply sound engineering judgment and technical expertise to solve complex problems; working knowledge of DFM, GD&T, and Six Sigma methodologies.

• Technical skills in biomedical design and delivery system catheter design.

• Ability to manage and collaborate with external vendors to meet quality, timeline, and technical requirements.

• Experience in rapid product development within cross‑functional teams, including creative design iteration, prototyping, and test method development (e.g., in‑vitro testing).

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 (CA), 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.