Join our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit as an NPD Engineer, advancing an innovative portfolio of technologies for patients with complex heart valve disease. In this role, you will contribute across the product lifecycle from Early Human Use through commercialization by developing and optimizing manufacturing processes that address critical unmet clinical needs. You will collaborate closely with R&D, Pilot, and commercial manufacturing teams, playing a key role in delivering life-changing therapies that help patients live longer, healthier lives.
How you'll make an impact:- Drive early-stage New Product Introduction (NPI) by developing and implementing scalable manufacturing processes and technologies that enable high-capacity, sustainable product lines within the TMTT portfolio.
- Support new product development by contributing to the design and development of implantable devices and delivery systems for cardiovascular therapies, from early concept through product launch.
- Execute engineering activities across the full development lifecycle, including design control support for manufacturing products and processes.
- Own nonconformance and MRB activities to support initial and early-phase manufacturing builds.
- Develop and execute operations strategies to successfully integrate new products into manufacturing, including product phase-in and phase-out activities aligned to design, regulatory, and clinical requirements.
- Lead manufacturing readiness and design transfer activities, including manufacturing readiness reviews (MRRs) and successful transfer of designs to production.
- Influence product and process specifications from an operations perspective, applying DFx principles, tolerancing, material selection, and automation to establish stability metrics, assess risk, and drive mitigation via SCRR and MRR forums.
- Develop and release manufacturing documentation, including drawings, SOPs, routers, pFMEAs, and mid-complexity training materials and work instructions to ensure effective knowledge transfer to production.
- Improve manufacturing processes through application of LEAN principles and basic statistical methods to drive continuous improvement, reduce non-value-added work, and positively impact cost standards and operational efficiency.
- Support, drive, and execute process qualifications and validations, including IQ, OQ, and PQ activities for manufacturing processes.
- Lead and support build strategies for QST, pre-DV, and DV phases by prioritizing activities and providing hands-on technical expertise.
- Partner with Pilot manufacturing teams to conduct root cause investigations for manufacturing issues prior to commercialization.
- Identify and implement equipment, tooling, and fixture improvements to enhance manufacturing capability, efficiency, and robustness.
- Apply Design for Manufacturability (DFM) principles by conducting design reviews and ensuring manufacturability considerations are embedded early in product development.
- Contribute flexibly to additional responsibilities and initiatives as business and project needs evolve.
What you'll need (Required):- Bachelor's Degree in Engineering or Scientific field with 2 years related experience including either industry or industry/education OR
- Master's Degree in Engineering or Scientific field or equivalent with related internship, senior projects, or thesis in industry/education
What else we look for (Preferred):- Demonstrated analytical and problem-solving skills, including the ability to assess complex technical challenges and develop effective, data-driven solutions in a fast-paced development environment.
- Strong written and verbal communication skills, with proven ability to generate clear, concise, and accurate technical documentation.
- Ability to work effectively in a highly collaborative, cross-functional team environment, including frequent interaction with R&D, manufacturing, quality, suppliers, and external stakeholders.
- Proven interpersonal, consultative, and relationship-management skills, including the ability to influence, negotiate, and align stakeholders without direct authority.
- High attention to detail and strong organizational skills to ensure accuracy, compliance, and execution excellence throughout the development lifecycle.
- Ability to work independently while managing competing priorities and delivering results with minimal oversight.
- Experience coordinating and managing vendors and project stakeholders in support of technical and program objectives.
- Proficiency with Microsoft Office tools, including Word, Excel, PowerPoint, and MS Project; CAD experience preferred where applicable.
This position may include travel of up to 10% for product transfer initiatives.
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 $87,000 to $123,000 (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.
