Process Validation Engineer

1 week ago

Santa Clara CA United States GForce Life Sciences Full time

Consultant, Manufacturing/Process Validation Engineer, Medical Device

Our client, a Cardiovascular start up, has engaged GForce Life Sciences to provide a manufacturing/process validation engineer. This position will report to a Sr Quality Director. This individual will be responsible for (XYZ). This position requires the ability to do Support the clients transition from clinical stage to commercialization within manufacturing, process, and automation engineering. Evaluate and optimize existing processes, design & implement custom fixtures, tooling, automated equipment within and outside a cleanroom environment. Work closely with the R&D, Operations, and Quality Systems staffs to improve existing processes and perform process validations. This hands-on role requires accountability and the ability to work with minimal supervision.

Duties / Expectations of Role

  • Document, assemble, and qualify production assembly / test / inspection fixtures and equipment.
  • Specify, procure and implement off the shelf automated and semi-automated equipment
  • Implement custom equipment as-needed.
  • Create verification or validation protocols, execute studies and/or tests, and author and release subject reports.
  • Assist in characterization studies and Design of Experiments (DoE).
  • Author and perform validation/verification of processes/inspection methods for manufacturing (IQ, OQ, PQ).
  • Write and maintain manufacturing documentation including material and component specifications, work instructions, BOMs, routers, Process FMEAs, DMR, protocols, reports, and DHF documents.
  • Maintain compliance with Ancora Heart’s quality systems including all applicable SOPs, non-conforming materials disposition, corrective action investigations and closure, and Engineering Change Order (ECO).
  • Train operators on new processes, tools, and equipment.
  • Work as the liaison among R&D, Operations, and Quality Systems to ensure a smooth transition of design changes, tooling, and fixturing.
  • Assure product and process quality by designing testing methods; testing sub-assemblies, finished product and process capabilities.
  • Develop, qualify and implement processes to improve manufacturability.
  • Complete projects and tasks in a timely manner consistent with corporate objectives. Keep manager informed of changes in work schedule and/or workload.
  • Maintain compliance to QSR systems in coordination with the Document Control and Quality Assurance functions.


Mandatory Requirements

  • Minimum B.S. in Mechanical Engineering, Biomedical Engineering, Materials Engineering, or similar Engineering discipline.
  • 5-9+ years of related experience
  • Knowledge of FDA, QSR and MDR regulations and relevant FDA Guidance and ISO standards.
  • Background in IQ/OQ/PQ
  • Process Validation – Experience with MVP (Master Validation Plans)
  • Knowledge and experience with Packaging (pouch sealing)
  • Experience with facility layout optimization
  • Experience with Test Method Validation and/or Gage R&R
  • SPC
  • Ability to work in a CER ISO 7 environment, engage with medical device assemblers to learn and understand current manufacturing challenges.
  • Background in DFMEA, Process Flowcharting, test methods, quality inspection methodology, report writing.
  • Experience in the development, design, and execution of process validation protocols
  • Solid protocol and writing skills
  • Experienced with Mini-Tab and SolidWorks

Nice to Have

  • Catheter Manufacturing, experience with auto-fusers, hot boxes, UV curing.
  • Design Transfer Experience
  • Quality Experience – capability analysis, CAPA, MRB, calibration, metrics, etc.


Term & Start

  • 9 months+
  • ASAP
  • Full time (40 hours/week)
  • Possibility of extension or perm
  • Onsite 5 days a week in Santa Clara
  • Benefits included (Medical, Dental, Vision, 401k)
  • Pay range - $60-70/hr

  • Process Validation Engineer

    4 weeks ago

    Santa Clara, United States GForce Life Sciences Full time

    Consultant, Manufacturing/Process Validation Engineer, Medical DeviceOur client, a Cardiovascular start up, has engaged GForce Life Sciences to provide a manufacturing/process validation engineer. This position will report to a Sr Quality Director. This individual will be responsible for (XYZ). This position requires the ability to do Support the clients...

  • Process Validation Engineer

    4 weeks ago

    santa clara, United States GForce Life Sciences Full time

    Consultant, Manufacturing/Process Validation Engineer, Medical DeviceOur client, a Cardiovascular start up, has engaged GForce Life Sciences to provide a manufacturing/process validation engineer. This position will report to a Sr Quality Director. This individual will be responsible for (XYZ). This position requires the ability to do Support the clients...

  • Manufacturing Process Validation Engineer

    4 weeks ago

    Santa Clara, California, United States GForce Life Sciences Full time

    Job Title: Manufacturing Process Validation EngineerGForce Life Sciences is seeking a highly skilled Manufacturing Process Validation Engineer to join our team. As a key member of our engineering team, you will be responsible for ensuring the quality and reliability of our medical devices.Key Responsibilities:Design and implement custom fixtures, tooling,...

  • Process Validation Specialist

    4 weeks ago

    Santa Clara, California, United States GForce Life Sciences Full time

    Job SummaryGForce Life Sciences is seeking a highly skilled Process Validation Engineer to join our team. As a key member of our manufacturing team, you will be responsible for ensuring the quality and reliability of our medical devices.Key ResponsibilitiesDevelop and implement process validation protocols to ensure compliance with FDA and ISO...

  • Process Validation Engineer

    2 months ago

    Atascocita, TX, United States Lonza Full time

    United States, Houston (Texas) Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers....

  • Electrical Validation Engineer

    3 weeks ago

    Santa Clara, California, United States Futran Tech Solutions Pvt. Ltd. Full time

    Electrical Validation EngineerAt Futran Tech Solutions Pvt. Ltd., we are seeking an Electrical Validation Engineer to join our team. The ideal candidate will have a strong background in computer engineering and experience with high-speed communication principles, circuits, and signal integrity principles. Additionally, they should have knowledge of computer...

  • Product Validation Engineer

    3 weeks ago

    Santa Clara, California, United States Anello Photonics Full time

    About Anello PhotonicsAnello Photonics is a leading-edge technology company based in Santa Clara, CA. The company has developed integrated photonic system-on-chip technology for next-generation navigation. Anello's SIPHOGTM gyroscope is based on its patented photonic integrated circuit technology. This results in a product that is higher performance, much...

  • Electrical Validation Engineer

    4 weeks ago

    Santa Clara, California, United States Futran Tech Solutions Pvt. Ltd. Full time

    Job Title: Electrical ValidationLocation: RemoteClient: LTTS/IntelJob Description:We are seeking a highly skilled Electrical Validation Engineer to join our team at Futran Tech Solutions Pvt. Ltd. The ideal candidate will have a strong background in computer engineering and experience in high speed communication principles, circuits, and signal integrity...

  • Senior Validation Engineer

    3 weeks ago

    Santa Clara, California, United States Jobot Full time

    Job SummaryWe are seeking a highly skilled Principal Product Validation Engineer to lead and contribute to the productization of our Analog/Mixed Signal and MEMS sensor-based products. The ideal candidate will have a strong background in validation, characterization, and fundamental knowledge of mixed signal circuits.Key ResponsibilitiesContribute and lead a...

  • Process Engineer

    4 weeks ago

    Santa Clara, California, United States Fabrinet West Full time

    ### Job Summary We are seeking a highly skilled Process Engineer to join our team at Fabrinet West. As a Process Engineer, you will be responsible for driving continuous improvement activities to support manufacturing processes, techniques, and methodologies. Your expertise will be crucial in maximizing production efficiency and achieving total customer...

  • Senior PCIe and Validation Engineer

    3 weeks ago

    Santa Clara, California, United States Nvidia Full time

    Job SummaryNVIDIA is seeking a highly skilled Senior PCIe and Validation Engineer to join our team. As a key member of our Silicon Solutions Group, you will be responsible for driving the planning and execution of PCIe and similar interfaces in the areas of functional bring-up, system-level validation, and troubleshooting for NVIDIA GPUs and SOCs.Key...

  • Process Engineer

    4 weeks ago

    Santa Clara, California, United States Fabrinet West Full time

    PURPOSE:As a Process Engineer at Fabrinet West, you will be responsible for driving continuous improvement activities to support manufacturing processes, techniques, and methodologies. Your goal will be to maximize production efficiency by leveraging statistical analysis and other analytical tools. You will work closely with the team to achieve total...

  • Silicon PCIe Bringup and Validation Engineer

    4 weeks ago

    Santa Clara, California, United States Ursus Inc Full time

    Job Summary:The Silicon PCIe Bringup and Validation Engineer will be responsible for the initiation and validation of the PCIe subsystems within Rivos SOC design. This role demands a comprehensive grasp of cutting-edge PCIe design tailored for server applications, covering aspects such as physical design, logic, performance, system, and software. The ideal...

  • Senior Process Validation Engineer

    2 months ago

    Barrett, TX, United States Lonza Full time

    United States, Houston (Texas) Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers....

  • Senior PCIe and Validation Engineer

    3 weeks ago

    Santa Clara, California, United States NVIDIA Full time

    NVIDIA is a leader in the field of artificial intelligence, high-performance computing, and visualization. Our invention, the GPU, serves as the visual cortex of modern computers and is at the heart of our products and services.As a PCIe and Validation Engineer at NVIDIA, you will be responsible for driving the planning and execution of PCIe and similar...

  • Senior System Validation Engineer

    3 weeks ago

    Santa Clara, California, United States Nvidia Full time

    Job SummaryWe are seeking a highly skilled Senior System Validation Engineer to join our Firmware Integration team at NVIDIA. As a key member of our team, you will be responsible for planning, building, and integrating NVIDIA's next-generation computing platforms.Key ResponsibilitiesBuild and bring up complex hardware systems in the lab, involving network...

  • Senior Validation Engineer

    4 weeks ago

    Santa Clara, California, United States Larsen & Toubro Full time

    Job Description & Skill Requirement:At Larsen & Toubro, we are seeking a highly skilled Post Silicon Validation Engineer to join our team. The ideal candidate will have expertise in validating PCIe, LPDDR controller/chips, and Ethernet interfaces for leading edge protocols, including DRAM functionality related to configuration, tuning, and debugging.Key...

  • System Design Validation Engineer

    4 weeks ago

    Santa Clara, California, United States Nvidia Full time

    Join NVIDIA's Team of Innovative EngineersNVIDIA is a leader in the field of artificial intelligence, deep learning, and autonomous vehicles. We are seeking a highly motivated and experienced System Design Validation Engineer to join our team.Key Responsibilities:Validate and debug NVIDIA's products, including GPU cards, MGX servers, and other cutting-edge...

  • Validation Engineer

    5 days ago

    Thousand Oaks, CA, United States EPITEC Full time

    Job Summary:The Senior Engineer will lead the development, qualification, validation, and transfer of physical test methods for combination products and medical devices in a GMP-regulated environment. This role emphasizes problem-solving, process improvement, and hands-on testing expertise. Candidates with experience in the pharmaceutical, medical device, or...

  • Senior Hardware Validation Engineer

    3 weeks ago

    Santa Clara, California, United States Futran Tech Solutions Pvt. Ltd. Full time

    Job Summary: We are seeking a highly skilled Senior Hardware Validation Engineer to join our team at Futran Tech Solutions Pvt. Ltd. as a BLT Engineer. The ideal candidate will have a strong background in hardware validation, with expertise in PCIe interface development and test equipment operation. Key Responsibilities: Design and develop test plans and...