Test and Systems Engineer

4 weeks ago

santa clara, United States Stealth Health Tech startup Full time

Join an innovative stealth startup dedicated to transforming the treatment of Peripheral Artery Disease (PAD) and Coronary Artery Disease (CAD) through a novel catheter-based technology. We’re seeking a motivated and energetic team member to help us bring life-changing solutions to market. If you’re passionate about advancing healthcare in a dynamic environment, we would love to hear from you.


Job Overview

We are seeking an experienced Test and Systems Engineer to join our team in developing advanced catheter-based medical devices that integrate with energy-based therapeutic systems. The ideal candidate will have a strong background in mechanical and electromechanical systems, be adept at designing test fixtures and tooling, and demonstrate proficiency in drafting test protocols and analyzing data. This role involves system-level testing of catheter devices, interface cables, and energy-generating equipment, as well as creating and maintaining mechanical drawings and product development process (PDP) documentation.


This individual will work closely with cross-functional teams to ensure that the testing and integration of catheter systems are carried out effectively and efficiently.


Key Responsibilities

Test Protocol Development & Execution:

  • Draft, review, and execute test protocols for both individual components and integrated system testing, including catheters, interface cables, and energy-generating systems.
  • Design and develop test fixtures and tooling to facilitate testing activities, ensuring accurate and repeatable results.

Data Analysis & Reporting:

  • Collect, analyze, and interpret test data using statistical analysis tools (e.g., Minitab, Excel) to ensure device performance meets specifications.
  • Create comprehensive test reports, summarizing results, statistical analyses, and recommendations for design improvements or changes.

Mechanical Design & Documentation:

  • Design mechanical components, fixtures, and tooling using SolidWorks or equivalent CAD software.
  • Draft and release detailed mechanical drawings, specifications, and other product development process (PDP) documents as needed.
  • Work closely with design and manufacturing teams to ensure that fixtures and tooling are manufacturable and compliant with design requirements.

System Integration & Testing:

  • Perform testing at both component and system levels, including integrated tests of catheter devices with energy-generating sources.
  • Troubleshoot mechanical and electromechanical issues related to system integration and provide solutions for optimizing performance.

Cross-Functional Collaboration:

  • Collaborate with R&D, quality, and regulatory teams to ensure that all testing and system integration activities meet regulatory and quality standards (FDA, ISO 13485, EU MDR).
  • Support the development and submission of regulatory documents, including verification and validation reports, to ensure compliance with global medical device regulations.

Project & Documentation Support:

  • Support the Senior Program Manager and R&D teams in maintaining project timelines, ensuring that testing activities align with overall project goals and deadlines.
  • Assist in the development and management of PDP documentation, including risk analyses, design verification and validation documents, and traceability matrices.


Qualifications

Education:

  • Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, or a related field.

Experience:

  • Minimum of 3 years of experience in test engineering, systems engineering, or a related role within the medical device industry.
  • Proven experience working with medical devices that integrate mechanical and electromechanical components, particularly catheter-based systems or energy-generating therapeutic devices.
  • Experience with regulatory requirements, including FDA 21 CFR 820, ISO 13485, and EU MDR.

Skills & Competencies:

  • Proficient in SolidWorks or equivalent CAD software for mechanical design.
  • Strong proficiency in Microsoft Excel for data analysis and experience using statistical software such as Minitab or equivalent.
  • Familiarity with document management tools (e.g., Grand Avenue Software, MasterControl, etc) is a plus.
  • Strong mechanical aptitude with experience in designing fixturing and tooling for testing medical devices.
  • Excellent problem-solving skills, with the ability to troubleshoot electromechanical systems and provide practical solutions.
  • Strong written and verbal communication skills, with the ability to create clear and concise test protocols, reports, and technical documentation.
  • Strong attention to detail and organizational skills, with the ability to manage multiple projects and meet deadlines in a fast-paced environment.

Preferred Qualifications:

  • Experience with catheter-based medical devices, energy-based therapeutic devices, or other Class II/III medical devices.
  • Experience working in a cross-functional team environment, supporting R&D, quality, and regulatory teams.
  • Familiarity with product lifecycle management (PLM) systems (e.g., Windchill, Agile).

Why Join Us?

  • Be a key contributor to the development of cutting-edge medical devices in a growing company.
  • Collaborate with a talented, multidisciplinary team in a highly innovative and regulated environment.
  • Competitive salary and benefits package, with ample opportunities for professional growth and development.


Equal Opportunity Employer

We are committed to fostering a diverse and inclusive workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or any other protected characteristic.

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