Sr. Engineer, Operational Excellence

Shockwave Medical, Inc. is a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Shockwave Medical aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque.

Position Overview

The Senior Operation Excellence Engineer will be responsible for leading the development of new manufacturing processes and technologies for new product introductions, and manufacturing process improvements for commercial products, incorporating Design Excellence and Continuous Improvement through the application of Industrial Engineering and Lean Six Sigma programs. The goal is to ensure optimal customer satisfaction, program efficiency, and financial effectiveness.

Essential Job Functions

1. Implement activities across the Santa Clara organization that ensure the use of operational excellence tools and strategies to:
1. Develop new manufacturing processes and technologies for new product introductions.
2. Ensure waste-reduction and improvement initiatives on the commercial product portfolio.
2. Lead process development projects using Industrial Engineering and Design Excellence concepts.
3. Lead engineering problem-solving and process improvement projects using best practices, ensuring accountability and completion.
4. Work with the New Product Development team to effectively design the manufacturing processes and technologies to meet customer demand and financial effectiveness.
5. Work with operations teams to identify potential projects, assess feasibility, and implement solutions.
6. Collaborate with the leadership team to identify and drive value opportunities and to ensure production and operation challenges are well understood and resourced for resolution.
7. Collaborate with business teams to review processes and identify/implement opportunities for improvements applying Lean Six Sigma concepts & tools.
8. Identify opportunities for cost reduction and work to improve cost performance.
9. Collect data and analyze process performance indicators to ensure business efficiency and quality requirements.
10. Communicate the status and issues of the projects to the organization in a timely, clear, and appropriate manner.
11. Identify potential operational risks and support the areas in the development of strategies to mitigate them.
12. Support deployment of a holistic operational excellence program for Shockwave Medical in alignment with Global Operations.
13. Coach Design Excellence and Lean Six Sigma tools and techniques to help the team analyze data effectively, identify problems, and drive process improvements.

Requirements

1. Bachelor's degree in Engineering discipline (Industrial Engineering preferred)
2. Minimum of five (5) years of demonstrated experience in the medical device industry or at least three (3) years leading Operational Excellence initiatives.
3. Certified: Lean Six Sigma Black Belt or equivalent.
4. Project Management experience or PM Certified (preferred).
5. Strong background in holistic operational excellence structures and the associated tools/techniques.
6. Knowledge of and compliance with applicable Quality System requirements (e.g., QSRs, ISO and MDD requirements).

Skills

1. Demonstrated problem-solving capabilities when dealing with ambiguity.
2. Ability to convey and communicate complex concepts simply and clearly.
3. Strong strategic thinking, problem-solving, analytical/critical thinking skills.
4. Ability to work in a fast-paced environment while managing multiple priorities.
5. Operate as a team and/or independently while demonstrating flexibility to changing requirements.

Market Range: 113,000 - 140,000

Exact compensation may vary based on skills, experience, and location.

Benefits

Shockwave Medical offers a competitive total compensation package as well as the following benefits and perks:

Core Benefits

Medical, Dental, Vision, Pre-tax and Roth 401k options with a fully vested match, Short-Term and Long-Term Disability, and Life Insurance, Employer contribution toward Health Savings Account (HSA), Competitive PTO balance.

Perks

ESPP, Calm App, Pet Insurance, Student Loan Refinancing, Spot Bonus awards.

EEO Employer