Staff 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

• Implement activities across the Santa Clara organization that ensure the use of operational excellence tools and strategies to:
• develop new manufacturing process and technologies for new products introduction.
• ensure waste-reduction and improvement initiatives on commercial product portfolio.Lead process development projects using Industrial Engineering and Design Excellence concepts.

• Lead engineering problem solving and process improvement projects using best practices, ensuring accountability and completion.
• Work with New Product Development team to effectively design the manufacturing process and technologies to meet customer demand and financial effectiveness.
• Works with operations teams to identify potential projects, assess feasibility, and implement solutions.
• Collaborating with the leadership team to identify and drive value opportunities and to ensure production and operation challenges are well understood and are resourced for resolution.
• Collaborate with business teams to review processes and identify/implement opportunities for improvements applying Lean Six Sigma concepts & tools.
• Identify opportunities for cost reduction and work to improve cost performance.
• Collect data and analyze process performance indicators to ensure business efficiency and quality requirements.
• Communicate the status and issues of the projects to the organization in a timely, clear, and appropriate manner.
• Identify potential operational risks and support the areas in the development of strategies to mitigate them.
• Support deployment of holistic operational excellence program for Shockwave Medical in alignment with Global Operations.
• Coaching Design excellence and lean six sigma tools and techniques to help the team to analyze data effectively, identify problems, and drive process improvements.
• Other duties as assigned.

• Bachelor's degree in Engineering discipline (Industrial Engineering preferred)
• Minimum of eight (8) years' of demonstrated experience in the medical device industry or at least 5 years leading Operational Excellence initiatives.
• Certified: Lean Six Sigma Black Belt or equivalent.
• Project Management experience or PM Certified (preferred).
• Strong background in holistic operational excellence structures and the associated tools/techniques
• Knowledge of and compliance with applicable Quality System requirements (e.g., QSRs, ISO and MDD requirements).

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

Market Range: $127,000 - $158,000

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: Calm App, Pet Insurance, Student Loan Refinancing, Spot Bonus awards

EEO Employer