Shockwave Medical
Manager, R&D
Shockwave Medical, Santa Clara, California, us, 95053
Position at Shockwave Medical
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 Manager of R&D provides leadership, technical support, and effectively manages and develops direct reports. Responsible for product and process development, resources, and project management activities associated with executing the company's goals and objectives.
Essential Job Functions
Manage, lead, and mentor engineer(s) and/or technician(s). Lead all cross-functional project activities from concept through clinical trial and commercial release of product. Mentor and support a variety of development and engineering activities, which mainly focus on catheter design and development. Design and develop product(s) in full compliance with the company's Design Control requirements and consistent with FDA, ISO and MDD requirements. Coordinate technical personnel and their activities involved in developing new and improved products and manufacturing processes. Ensure that development activities are properly documented through lab notebook, history file, and other records. Coordinate cross-functional alignment and support for program success. Manage outside vendors and contractors providing products or services. Create, maintain, and communicate project timelines for internal and outside development projects. Provide regular updates of key milestones and issues to the project team as well as management. Identify issues and recommend solutions for products in development. Contribute ideas to new products, as defined by product specification requirements. Approve test methods, acceptance criteria, and test equipment for all stages of product development. Coordinate and participate in events, which provide clinical feedback such as animal studies, physician interface meetings, and Human Clinical Studies. Ensure that products satisfy acceptable quality standards and customer needs with consensus from cross-functional groups. Review and approve documents as specified in Document Control SOP. Compile the Design History File and conduct design reviews in compliance with Design control procedures. Ensure that products have capable manufacturing processes and that process verifications and validations are completed. Interact with cross-functional groups to ensure that products are compatible with other products in the intended operating system, and have met all requirements per design control process. Other duties as assigned. Requirements
B.S. in Engineering or equivalent work experience. Minimum of 10 years' progressive experience in medical device development, including 3+ years' experience in leading projects in all phases of product development. 2+ years managing direct reports or equivalent experience. Knowledge of QSR and applicable Quality System Standards. Experience with disposable medical device development preferably coronary and/or vascular catheters. Strong understanding of engineering materials, component selection, and design for safety, reliability and manufacturability. Solid communication and presentation skills with level of comfort being the spokesperson and leader of a team. Experience taking a product from concept through clinical or commercial release. 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. Employee may be required to lift objects up to 25lbs. Market Range: $167,000 - $209,000 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
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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 Manager of R&D provides leadership, technical support, and effectively manages and develops direct reports. Responsible for product and process development, resources, and project management activities associated with executing the company's goals and objectives.
Essential Job Functions
Manage, lead, and mentor engineer(s) and/or technician(s). Lead all cross-functional project activities from concept through clinical trial and commercial release of product. Mentor and support a variety of development and engineering activities, which mainly focus on catheter design and development. Design and develop product(s) in full compliance with the company's Design Control requirements and consistent with FDA, ISO and MDD requirements. Coordinate technical personnel and their activities involved in developing new and improved products and manufacturing processes. Ensure that development activities are properly documented through lab notebook, history file, and other records. Coordinate cross-functional alignment and support for program success. Manage outside vendors and contractors providing products or services. Create, maintain, and communicate project timelines for internal and outside development projects. Provide regular updates of key milestones and issues to the project team as well as management. Identify issues and recommend solutions for products in development. Contribute ideas to new products, as defined by product specification requirements. Approve test methods, acceptance criteria, and test equipment for all stages of product development. Coordinate and participate in events, which provide clinical feedback such as animal studies, physician interface meetings, and Human Clinical Studies. Ensure that products satisfy acceptable quality standards and customer needs with consensus from cross-functional groups. Review and approve documents as specified in Document Control SOP. Compile the Design History File and conduct design reviews in compliance with Design control procedures. Ensure that products have capable manufacturing processes and that process verifications and validations are completed. Interact with cross-functional groups to ensure that products are compatible with other products in the intended operating system, and have met all requirements per design control process. Other duties as assigned. Requirements
B.S. in Engineering or equivalent work experience. Minimum of 10 years' progressive experience in medical device development, including 3+ years' experience in leading projects in all phases of product development. 2+ years managing direct reports or equivalent experience. Knowledge of QSR and applicable Quality System Standards. Experience with disposable medical device development preferably coronary and/or vascular catheters. Strong understanding of engineering materials, component selection, and design for safety, reliability and manufacturability. Solid communication and presentation skills with level of comfort being the spokesperson and leader of a team. Experience taking a product from concept through clinical or commercial release. 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. Employee may be required to lift objects up to 25lbs. Market Range: $167,000 - $209,000 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
#J-18808-Ljbffr