Senior Manufacturing Engineer

5 days ago

Santa Clara, California, United States Shockwave Medical Full time
Job Title: Senior Manufacturing Engineer

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

Job Summary

The Senior Manufacturing Engineer is responsible for designing, developing, testing, documenting, and implementing processes, tooling, and fixtures for throughout the product lifecycle, from design to production. This role will work closely with production, quality, and R&D teams to support the company's manufacturing operations and product launch timelines.

Key Responsibilities
  • Work collaboratively with R&D, QA, and Production departments to design, develop, test, document, and implement processes, tooling, and fixtures.
  • Support and work with Quality to address and resolve non-conformances.
  • Collect data and analyze process performance and capabilities for company products, including new products and products already in production.
  • Identify process requirements, advise and support operations management, and implement equipment and fixturing needed for process development and manufacturing efforts.
  • Develop and maintain documentation for design control, product configurations, manufacturing procedures, lot history records, and other Quality System requirements.
  • Lead and/or actively participate in product/process engineering problem solving using DMAIC methodology.
  • Lead and/or actively participate in process/product continuous improvement projects (in cooperation with development engineers and technicians).
  • Apply Lean manufacturing principles in production processes to reduce/eliminate waste and increase productivity.
  • Assist Procurement and R&D departments with supplier selection and technical development.
  • Perform productivity and costing analyses (e.g., calculate direct labor and materials costs for new products, identify and implement cost reduction plans for existing products).
Requirements
  • Bachelor's degree in Engineering.
  • Minimum of five (5) years of experience in a medical device environment or, 3 years of experience with a Master's Degree.
  • Knowledge of and compliance with applicable Quality System requirements (e.g., traceability QSRs, ISO and MDD requirements).
  • Experience with implementing Lean and Lean Sigma concepts.
  • Experience with Validation of Medical Devices (IQ-OQ-PQ).
  • Proficiency in Statistics (Cpk, Hypothesis Testing, DOE, Gage R&R) a plus.
  • Ability to use special software such as: Solidworks, Minitab or closely related.
  • 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.
Benefits

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

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

  • Senior Manufacturing Engineer

    2 weeks ago

    Santa Clara, California, United States Cirtec Medical Corporation Full time

    Job Title: Senior Manufacturing EngineerCirtec Medical Corporation is seeking a highly skilled Senior Manufacturing Engineer to join our team. As a Senior Manufacturing Engineer, you will be responsible for maintaining, developing, and implementing cost-effective manufacturing processes and methods.Key Responsibilities:Develop and implement robust...

  • Senior Manufacturing Engineer

    1 week ago

    Santa Clara, California, United States Shockwave Medical Full time

    Job Title: Senior Manufacturing EngineerShockwave Medical is a pioneering company in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. We are seeking a highly skilled Senior Manufacturing Engineer to join our team.Job SummaryThe Senior Manufacturing Engineer will be responsible for...

  • Senior Manufacturing Process Engineer

    2 weeks ago

    Santa Clara, California, United States Abbott Laboratories Full time

    About the RoleWe are seeking a highly skilled Senior Manufacturing Process Engineer to join our team at Abbott Laboratories. As a key member of our manufacturing organization, you will play a critical role in ensuring the efficient operation of our production area, optimizing existing processes, and meeting production goals.Key ResponsibilitiesMonitor and...

  • Senior Manufacturing Engineer

    1 month ago

    Santa Clara, California, United States Cirtec Medical Corporation Full time

    Job OverviewThis role is situated within a dynamic and innovative environment.ABOUT CIRTEC MEDICAL CORPORATIONCirtec Medical Corporation is not merely a design firm or contract manufacturer; we provide a comprehensive suite of vertically integrated services. Our expertise lies in the production of intricate components and devices utilizing cutting-edge...

  • Senior Product Engineer

    4 weeks ago

    Santa Clara, California, United States OMNIVISION Full time

    Job SummaryWe are seeking a highly skilled Senior Product Engineer to join our team at OMNIVISION. As a key member of our product development team, you will be responsible for bringing new products from tapeout to mass production.Key ResponsibilitiesDesign and develop characterization/testing plans to ensure product performance meets requirements.Collaborate...

  • Senior Manufacturing Engineer

    1 week ago

    Santa Ana, California, United States Primary Talent Partners Full time

    Senior Manufacturing EngineerPrimary Talent Partners is seeking a highly skilled Senior Manufacturing Engineer to join a multinational medical device company in Santa Ana, CA. This is a 12-month contract position with the possibility of extension or conversion to a full-time role.Job SummaryWe are looking for an experienced Manufacturing Engineer to support...

  • Senior Manufacturing Engineer

    2 weeks ago

    Santa Ana, California, United States Grove Technical Resources, INC Full time

    Job Title: Senior Manufacturing Engineer - On W2Grove Technical Resources, INC is seeking a highly skilled Senior Manufacturing Engineer to join our team. As a key member of our engineering team, you will be responsible for designing and implementing manufacturing processes, procedures, and production layouts for assemblies, equipment installation,...

  • Senior Layout Engineer

    2 weeks ago

    Santa Clara, California, United States Johnson & Johnson Full time

    Job Title: Senior Layout EngineerWe are seeking a highly skilled Senior Layout Engineer to join our team at Johnson & Johnson. As a key member of our Hardware Team, you will be responsible for designing and developing complex printed circuit board (PCB) layouts for our next-generation robotic platforms.Key Responsibilities:Design and develop PCB layouts for...

  • Senior Process Engineer

    2 days ago

    Santa Clara, California, United States Halo Industries Full time

    Job Title: Senior Process EngineerHalo Industries, Inc. is a pioneer in manufacturing innovation with light-based technologies. We are seeking a highly skilled Senior Process Engineer to join our dynamic team.The OpportunityWe are planning our volume manufacturing operations and building a passionate team to meet our next milestone of deploying the company's...

  • Senior Structural Testing Engineer

    1 week ago

    Santa Clara, California, United States NVIDIA Full time

    Job Title: Senior Structural Testing EngineerNVIDIA is a leader in the field of artificial intelligence and high-performance computing. We are seeking a highly skilled Senior Structural Testing Engineer to join our Manufacturing Test Team.The ideal candidate will have a strong background in electrical engineering, mechanical engineering, or a related field,...

  • Senior Structural Testing Engineer

    5 days ago

    Santa Clara, California, United States NVIDIA Full time

    Job Title: Senior Structural Testing EngineerNVIDIA is a leader in the field of artificial intelligence and high-performance computing. We are seeking a highly skilled Senior Structural Testing Engineer to join our Manufacturing Test Team.The ideal candidate will have a strong background in electrical engineering and experience in structural testing. They...

  • Senior Systems Engineer

    3 weeks ago

    Santa Clara, California, United States iSoftTek Solutions Inc Full time

    Job Title: Senior Systems EngineerAt iSoftTek Solutions Inc, we are seeking a highly skilled Senior Systems Engineer to join our team. As a key member of our product development team, you will be responsible for designing, building, testing, and manufacturing advanced high-productivity e-beam lithography tools.Key Responsibilities:Work with a team to...

  • Senior Manufacturing Engineer

    9 hours ago

    Santa Clarita, California, United States Woodward Full time

    Job SummaryWe are seeking a highly skilled Senior Manufacturing Engineer to join our team at Woodward. As a key member of our Technical Leadership group, you will be responsible for designing and supporting moderate to high complexity manufacturing systems and equipment, mentoring junior engineers, and driving process improvements.Key...

  • Senior Test Engineer

    1 week ago

    Santa Clara, California, United States Nvidia Full time

    Join NVIDIA's Team of ExpertsWe are seeking a highly skilled and experienced Senior Test Engineer to join our team at NVIDIA. As a key member of our System Level Test (SLT) team, you will be responsible for creating and verifying diagnostic test programs for our state-of-the-art GPU products.Key Responsibilities:Develop, validate, and support manufacturing...

  • Senior Product Engineer

    3 weeks ago

    Santa Clara, California, United States OMNIVISION Full time

    Job SummaryWe are seeking a highly skilled Senior Product Engineer to join our team at OMNIVISION. The successful candidate will be responsible for bringing new products from tapeout to mass production, working closely with R&D teams and manufacturing engineers to resolve technical issues and meet performance requirements.Key ResponsibilitiesDevelop and...

  • Senior Manufacturing Engineer

    3 weeks ago

    Santa Clarita, California, United States Woodward, Inc. Full time

    Job SummaryWoodward, Inc. is seeking a highly skilled Senior Manufacturing Engineer to join our team. As a key member of our Technical Leadership group, you will be responsible for designing and supporting moderate to high complexity manufacturing systems and equipment.Key ResponsibilitiesInitiate, justify, and implement new advanced capital equipment...

  • Senior Structural Testing Engineer

    3 weeks ago

    Santa Clara, California, United States NVIDIA Full time

    Job Title: Senior Structural Testing EngineerNVIDIA is a leader in the technology industry, and we're looking for a skilled Senior Structural Testing Engineer to join our team. As a key member of our Manufacturing Test Team, you will play a critical role in building next-generation boards and systems, working closely with cross-functional teams and suppliers...

  • Senior Hardware Test Engineer

    5 days ago

    Santa Clara, California, United States NVIDIA Full time

    Job Title: Senior Hardware Test EngineerWe are seeking a highly skilled Senior Hardware Test Engineer to join our Test Solutions Group at NVIDIA. As a key member of our team, you will be responsible for developing manufacturing test solutions for Datacenter and Enterprise products.Key Responsibilities:Define manufacturing hardware test solutions that...

  • Senior Product Engineer

    3 weeks ago

    Santa Clara, California, United States Anello Photonics Full time

    About Anello PhotonicsAnello Photonics is a pioneering technology company based in Silicon Valley, California. We specialize in developing cutting-edge photonic system-on-chip technology for next-generation navigation systems. Our flagship product, the SIPHOGTM gyroscope, is a game-changer in the industry, offering higher performance, smaller size, and...

  • Senior Failure Analysis Engineer

    2 weeks ago

    Santa Clara, California, United States TalentBurst Full time

    Job Title: Senior Failure Analysis EngineerLocation: Santa Clara, CADuration: 12 months contractJob Summary:We are seeking a highly skilled Senior Failure Analysis Engineer to join our team. The successful candidate will be responsible for driving returned product failure analysis, characterizing failures, and escalating issues and trends to the Hardware...