Shockwave Medical Careers

Description

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 Operational Excellence Best Practices (Standard Work, 5S, Gemba, and other OPEX tools) in the commercial and new operations at the Santa Clara, US operations. 
• Leading complex projects to efficiently prioritize and address issues, ensuring their resolution within established timelines.
• Acting as a Subject Matter Expert in process development and continuous improvement, partnering with all levels of the Santa Clara organization.
• 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.
• Coach and lead multi-disciplinary teams to understand Lean and Design principles, map processes and identify wastes, as well as gaining a deep insight into customer needs and using these to inform design decision and trade-off.
• Deploy, deliver, and develop competencies that establish the holistic operational excellence program for Shockwave Medical in alignment with corporate.
• Challenges status quo and drives:
• design for manufacturability by creating a process with the end in mind of optimally building the efficiencies of Six Sigma methodology into the process before implementation.
• continuous improvement by establishing a solid foundation and implementing a standard way of working, systems, processes, and frameworks and iterating based on team and customer feedback to sustain performance and drive the successful management of operations.
• Promotes design for manufacturing and continuous improvement mindset through communication, training, and implementing best practices, ensuring accountability through governance.
• Drive a value centered culture aligned with Operational Excellence Principles.
• Conducts regular Gemba assessments to understand and guide operational excellence maturity.
• Partner with department owners to create and deploy operational goals at lower levels of the organization that align with strategic goals.
• Lead and sustain the Long Range Global Strategic Capacity business process to secure installed capacity that support business growth and meet customer expectations.   
• Identify opportunities for operational scaling, improvements, and streamlining processes across departments to enhance efficiency, reduce costs, and maintain high-quality standards.
• Coaches’ leaders on appropriate design and problem-solving approach for new product development and key operations issues.
• Identify potential operational risks and support the areas in the development of strategies to mitigate them.
• Provide strategic, tactical, and operational input to cross-functional team.
• Key Success Measures will include Operational Excellence Maturity Assessments; Design and Lean Six Sigma Certifications, Rate of improvement on Quality, Service & Cost; (e.g. Operations Site Productivity, Business Process Efficiency).
• Other duties as assigned. These job requirements are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel.

• Bachelor’s degree in engineering or equivalent experience.
• Minimum of ten (10) years’ of demonstrated experience in the medical device industry and  at least 5 years leading Operational Excellence initiatives.
• Certified: Design 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 leadership abilities capable of inspiring teams to operational excellence.
• Strong principle-centered approach that can be balanced on the organization need and starting point.
• Dynamic and engaging facilitation/training skills.
• Solid coaching and mentoring competency.
• Strong communicator with ability to influence, build consensus and gain support without direct authority.
• Proven experience in process improvement processes.
• 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.

Market Range: $121,000 - $151,000
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