Senior Systems Engineer

23 hours ago

Santa Clara, CA, United States Tranzeal Full time
Summary:
This Senior Systems Engineer will be part of the System Development team focusing on the
development of Client IVD automated systems and end-to-end product solutions. The individual is expected to provide technical and process expertise in collaboration with internal stake holders and cross functional teams throughout total product development lifecycle to develop and maintain medical device products, according to customer requirements, applicable regulatory and quality standards. This role is expected to lead and mentor less experienced engineers and their career development.

Responsibilities:
This position is responsible for, but not limited to, the following:
  • Provide technical expertise to cross-functional teams to develop IVD systems and ensure the product design will meet customer requirements as well as applicable standards and regulations;
  • Develop and manage systems level product requirements;
  • Perform product risk management activities;
  • Develop and execute verification/validation activities and traceability analysis;
  • Create artifacts required for project deliverables;
  • Resolve issues found according to company's defect/change tracking process;
  • Maintain knowledge of current regulatory requirements and standards as they pertain to the development and testing of medical/IVD devices;
  • Maintain compliance as required by regulatory bodies and the company's quality system;
  • Collaborate with cross functional teams to identify opportunities for continuous process improvement;
  • Lead and mentor less experienced Systems Engineers;
  • Support FDA and other regulatory submission and audits;

Who you are
You're someone who wants to influence your own development. You're looking for a company where you have the opportunity to pursue your interests across functions and geographies.

Where a job title is not considered the final definition of who you are, but the starting point.

Qualifications:
  • Bachelor's degree in Systems Engineering, Biomedical Engineering, Electrical Engineering or related disciplines. Advanced degree preferred;
  • 5+ years of professional experience in the medical device industry. Experience in IVD industry highly desirable;
  • Hands-on experience with liquid pipetting systems such as Hamilton, Tecan etc. is a plus;
  • Experience developing product requirements and design inputs;
  • Experience conducting risk management activities per ISO 14971;
  • Strong analytical, problem solving, communication, and interpersonal skills;

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