Quality Assurance Engineering Manager, Sustaining HW/SW

2 weeks ago


Santa Clara County, United States SciPro Full time

Daily Responsibilities:

  • Lead and mentor Quality Engineers and Technicians.
  • Oversee Quality Transfer and Design Control to manufacturing making sure process is scalable
  • Monitor field issues of product and resolve with through collaboration with suppliers
  • Ensure compliance with regulations and industry standards.
  • Oversee daily quality activities and maintain budget.
  • Support manufacturing and operations, both internally and with external vendors.
  • Drive process improvements and participate in supplier quality activities.
  • Manage design control, risk management, and compliance for sustaining projects.
  • Conduct hardware and software verification and validation.
  • Audit Design History Files (DHFs) for compliance.
  • Investigate and document results for returned devices and complaints.
  • Maintain the Servicing Program and support distribution quality activities.
  • Analyze quality metrics and initiate Document Change Orders (DCOs).
  • Participate in audits and support regulatory submissions.


Qualifications:

  • Education: Bachelor’s in Electrical/Software Engineering (Master’s preferred).
  • Experience: 10+ years in Hardware and Embedded Software Design, with 8+ years in the Medical Device industry.
  • Technical Skills:
  • Analog and Digital Circuit Design, PCB Layout, and prototype development.
  • Embedded systems, version control, issue tracking, and control electronics for medical devices.
  • Management: 2+ years managing others or equivalent experience.
  • Regulations: Knowledge of ISO 13485, ISO 14971, IEC 62304, IEC 60601, 21 CFR Part 820, MDD 93/42/EEC, EU MDR, and MDSAP.
  • Statistical Analysis: Proficient with Minitab and statistical techniques.
  • Preferred Experience: Class III medical devices and electromechanical products, complaint investigations.



  • Santa Clara, United States Disability Solutions Full time

    Johnson & Johnson is recruiting for a Manager, Sustaining Quality Engineering (Hardware/Software) for Shockwave Medical Inc. located in Quality Santa Clara, CAAt Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are...


  • Santa Clara, California, United States Apple Full time

    **Job Description:** Sr. System Software Engineer will drive the ideation and execution of prototypes of both SW and HW features in the home space.We're seeking an experienced SW engineer with a strong SW architecture background and good practical problem-solving abilities.Responsibilities:Design, develop, and test SW and HW features.Analyze customer...


  • Santa Clara, California, United States Apple Full time

    **About the Role:** We're looking for a skilled system SW engineer to join our team and contribute to the development of innovative products.The ideal candidate will have a strong SW architecture background, good practical problem-solving skills, and extensive experience developing for iOS at both Application and framework levels.Responsibilities:Develop and...


  • Santa Clara, California, United States Shockwave Medical Full time

    Job OverviewAs a Senior Sustaining Quality Engineering Manager at Shockwave Medical, you will provide leadership to the Sustaining Quality Engineering group, working closely with internal and external departments to efficiently deliver safe and effective medical devices to customers in compliance with company policies and procedures.Key...


  • Santa Clara, California, United States Apple Full time

    **Company Overview:**Sr. System Software Engineer plays a key role in driving the ideation and execution of prototypes of both SW and HW features in the home space.At Apple, we're committed to creating innovative products that surprise and delight our customers. Our dynamic startup-like environment offers the tools, resources, and support of the world's...


  • Santa Clara, California, United States Shockwave Medical, Inc. Full time

    **About the Role:**We are seeking a seasoned Quality Engineering Manager to lead our Sustaining Quality Engineering team at Shockwave Medical, Inc. The successful candidate will provide leadership and oversight to ensure compliance with industry regulations and company standards.**Key Responsibilities:**Oversight of sustaining quality activities for...


  • Santa Clara, United States Solid System Team GmbH Full time

    NVIDIA has been redefining computer graphics, PC gaming, and accelerated computing for decades. Today, we are increasingly known as “the AI computing company” — with the GPU deep learning ignited modern AI, acting as the brain of computers, robots, and self-driving cars etc. We are hiring a System Software Engineer who will help build outstanding...


  • Santa Clara, United States Arista Networks, Inc. Full time

    Company Description Arista Networks is an industry leader in data-driven, client-to-cloud networking for large data center, campus and routing environments. What sets us apart is our relentless pursuit of innovation. We leverage the latest advancements in cloud computing, artificial intelligence, and software-defined networking to provide our clients with a...


  • Santa Clara, California, United States Fabrinet West Full time

    About the RoleWe are seeking a highly motivated and experienced Quality Assurance Engineer to join our team at Fabrinet West. As a key member of our quality assurance team, you will be responsible for developing and implementing quality control processes, ensuring the accuracy and reliability of our products.Key Responsibilities:Develop and implement quality...


  • Santa Clara, California, United States Shockwave Medical Full time

    OverviewShockwave Medical, Inc. is a pioneering medical device company that has revolutionized the treatment of complex calcified cardiovascular disease with its innovative Intravascular Lithotripsy (IVL) technology.SalaryThe estimated salary for this position ranges from $144,000 to $180,000 per year, depending on skills, experience, and location.Job...


  • Santa Clara, United States Apple Full time

    The home architecture and sensing organization is looking for a strong system SW engineer covering a number of areas. Join our dynamic startup-like environment with all of the tools, resources, and support of the world’s largest hardware company. We are a close-knit group of engineers who work with a singular focus...to surprise and delight our customers...


  • Santa Clara, California, United States QualiTest Group Full time

    Job Overview: Quality Assurance EngineerWe are seeking a skilled Quality Assurance Engineer to join our team in Seattle, Washington. As a Quality Assurance Engineer at QualiTest Group, you will be responsible for ensuring the quality of our software products by designing and developing automated testing solutions.Responsibilities:Design and Develop Automated...

  • SW Quality Engg

    3 weeks ago


    Santa Clara, United States Alpha Net Consulting LLC Full time

    Alpha Net Consulting LLC - multiple openings - all levels: SW Quality Engg. Visit for details on edu/exp/skill req & salary. Travel req. Apply with resume to HR, 3211 Scott Blvd., Ste 203, Santa Clara, CA ;


  • Santa Clara, United States ATR International Full time

    Job DescriptionJob DescriptionWe are seeking a Product and Test Engineering Assistant  for a very important client. Job Description    The engineering assistant support a team of product/test engineers in sustaining/engineering activities within the PTE group. He/she needs to be on site a local test house daily to support ATE test program loading, data...


  • Santa Clara, United States ATR International Full time

    Job DescriptionJob DescriptionWe are seeking a Product and Test Engineering Assistant for a very important client.The engineering assistant support a team of product/test engineers in sustaining/engineering activities within the PTE group. He/she needs to be on site a local test house daily to support ATE test program loading, data collection and reports...


  • Santa Clara, California, United States Palo Alto Networks Full time

    Job OverviewPalo Alto Networks is seeking a highly skilled Sr. HW Failure Analysis Engineer to join our dynamic Hardware Quality Engineering team.


  • Santa Clara, California, United States RIT Solutions, Inc. Full time

    At RIT Solutions, Inc., we are seeking a highly experienced Quality Assurance Engineer to join our team. As a Senior Software Test Engineer, you will be responsible for designing and implementing effective test solutions to ensure the high quality of our products.Key Responsibilities: Develop, automate, and maintain highly effective test cases in a CI/CD...


  • Santa Clara County, United States L&T Technology Services Full time

    Requirements:3-10 years of experienceBoard/System SW+HW bring up experience. Test functional features of product (e.g., Server box). Any system/board experience is needed. Ability to setup new HW based on instructions, install OS/FWs as neededUse existing utilities to test functional features of a system. Automate + Integrate those utilities for factory...


  • Santa Clara, California, United States FranklinWH Energy Storage Inc. Full time

    Quality Assurance ManagerFranklinWH Energy Storage Inc. is a rapidly expanding company driven to become the leader in the global energy home storage system (ESS) industry.We offer whole home energy solutions typically coupled with solar PV systems, bringing households into the modern all-electric future.Job Title: Senior Quality Assurance ManagerEstimated...


  • Santa Clara, California, United States ATR International Full time

    We are seeking a highly skilled Product and Test Engineering Assistant to join our team at ATR International. This role offers an exciting opportunity to support product and test engineering activities within the PTE group.The successful candidate will work closely with test floor technicians to change Automated Test Equipment (ATE) test setups, handle...