Principal Systems Test Engineer

4 hours ago

Eden Prairie, Minnesota, United States ACIST Medical Systems Full time
Job Title: Principal Systems Test Engineer

We are seeking a highly skilled and experienced Principal Systems Test Engineer to join our team at ACIST Medical Systems.

Job Summary:

The Principal Systems Test Engineer will be responsible for leading the development and execution of comprehensive testing strategies for our medical devices. This key technical leadership role requires a deep understanding of medical device systems, strong leadership abilities, and a passion for ensuring product quality and compliance with regulatory standards.

Key Responsibilities:
  • Lead the planning, design, and execution of system-level testing for medical devices, ensuring compliance with regulatory requirements (e.g., FDA, ISO).
  • Develop and implement test plans, protocols, and procedures to verify and validate product functionality, performance, and reliability.
  • Analyze and interpret test data, identify issues, and drive root cause analysis and resolution.
  • Provide leadership and execution of best test method practices as part of a project team.
  • Collaborate with cross-functional team members to ensure alignment on testing objectives and deliverables.
  • Design clean, easy to use test fixtures and user interfaces for test equipment that measures robustness of design, provide error-checking, collects data and gives user feedback for acceptance and/or failure.
  • Create and maintain traceability of test cases to requirements.
  • Support regulatory submissions and audits by providing technical expertise and documentation.
  • Use critical thinking and technical knowledge to solve complex system interaction problems.
Requirements:
  • Bachelor's degree in engineering, or other scientific discipline, preferably electrical, mechanical, software, biomedical systems, control engineering.
  • 8+ years of experience in design verification.
  • Proven track record of leading and executing complex system-level tests for medical devices.
  • Experience in coordinating and working with external test labs.
  • Experience with electromechanical systems, sensors, control and data acquisition systems development.
  • Proven background in automated test system development.
  • Excellent communication and interpersonal skills, with the ability to work effectively in a collaborative team environment.
  • Strong analytical and problem-solving skills with the ability to troubleshoot complex system issues.
  • Experience creating test fixtures with Python and LabVIEW.
  • Ability to grow productive, trusting, and open relationships with functional partners.
  • High degree of organizational skills and high attention to detail.
  • Ability to handle multiple tasks and prioritize effectively.
  • Ability to work both independently and as part of a team.
  • Ability to develop protocols, conduct system tests and write reports.
  • Ability to select and use appropriate statistical techniques to design experiments and analyze data.
Preferred Qualifications:
  • Graduate degree in Engineering (EE, ME, SW or Systems Engineering) or another scientific discipline.
  • 10+ years of design verification experience.
  • In-depth knowledge of medical device regulations and standards (e.g., FDA, ISO 13485, IEC).
  • Experience with test automation tools and software.
  • Proficient in programming languages such as C, Python, LabVIEW.
  • Project management experience and certification (e.g., PMP) is desirable.
  • Good understanding of production test equipment design issues such as user friendliness, serviceability, ruggedness and has implemented and transferred equipment to external suppliers for high-volume manufacturing.
  • Awareness and working knowledge of system-level constraints in all disciplines, including mechanical, electrical, human factors and software.
  • Knowledge of latest industry trends, emerging technologies, and regulatory changes to continuously improve testing methodologies.
Other Requirements:
  • Adheres to all company policies, procedures and business ethics codes and ensures that they are communicated and implemented with the team.
  • Ability to travel up to 10% of the time.

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