Principal Engineer, Supplier Development Engineering

Job Description Summary:

Innovation starts from the heart. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering

lasting solutions for unmet patient needs. Our Principal Engineer, Supplier Development position is a unique career opportunity that could be your next step towards an exciting future.

You’ll make an impact by:

• The Principal Engineer, Supplier Development will reside in the Transcatheter Heart Valve (THV) Supplier Development Engineering team to provide manufacturing engineering support in the design and development of implantable devices and delivery systems to treat cardiovascular disease.

• Conduct engineering activities from the initial product development phase through product launch.

• Provide technical input for strategic sourcing projects, including evaluation of supplier capability, part qualification plan, specification review, product implementation and part transition to manufacturing.

• Develop manufacturing technologies to meet new product demands.

• Support manufacturing readiness reviews, supply chain readiness reviews, and manage design transfers to production environment.

• Manage product phase in/phase out activities around design, regulatory and clinical requirements.

• Lead supplier validation activities, support milestone builds and commercialization of new product introduction. Integrate new products into manufacturing.

• Conduct reviews to ensure DFM considerations are incorporated into designs. Assess and develop supplier part capability.

• Participate in technical discussions with suppliers to identify and implement improvements in products and processes.

• Perform design and drawing reviews to ensure that components meet desired capabilities for manufacturing.

• Responsible for defining supplier qualification requirements for OEM, Contract manufacturer (components and devices) and custom materials, including supplier validations

• Lead recurring technical meetings with critical outsourced component/ assembly suppliers

• Respond with a high sense of urgency to quality issues and escalate / communicate appropriately.

• Ensure that Tier 1 suppliers are using capable Tier 2 suppliers and resolve any inter-company conflict effectively

• Strategically bring various cross functional teams and suppliers in alignment on outstanding issues in a timely manner.

• Work with suppliers to optimize processes, reduce cost, ensure lean manufacturing as well as remove any waste from processes.

• Develop and manage project milestones in line with development and commercialization needs.

• Perform supplier risk & capacity assessment and take appropriate actions to ensure timely and successful commercialization

• Audit suppliers for their technical capabilities as well as quality criteria.

• Perform other duties and responsibilities as assigned.

What you’ll need (required):

• Bachelor's Degree in in Engineering or Scientific field, minimum of 6 years of experience OR

• Master's Degree in Engineering or Scientific field, minimum of 5 years of experience OR

• Ph.D. or equivalent in Engineering or Scientific field, minimum of 2 years of experience

• On-site work required.

• Up to 20% domestic/international travel.

What else we look for (preferred):

• Experience in the use of statistical tools required (SPC, Six Sigma, DMAIC, etc.)

• Experience in catheter assembly and related sub-assembly components manufacturing technologies in the development of cardiovascular and/or endovascular devices, minimally invasive endoscopy and implantable devices.

• Proven expertise in usage of MS Office Suite

• Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills

• Ability to translate technical information to all levels of the organizations

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

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

• Extensive understanding of processes and equipment used in assigned work

• Strong leadership skills and ability to influence change

• Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing

• Strict attention to detail

• Ability to interact professionally with all organizational levels

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

• Must be able to work in a team environment, including frequent inter-organizational and outside customer contacts

• Represents organization in providing solutions to difficult technical issues associated with specific projects

• 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 (CA), the base pay range for this position is $118,000 to $167,000 (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.   

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

COVID Vaccination Requirement

Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.