Sr. Systems Engineer - Medical Device - Contribute to development of COVID-19 Vaccine
San Diego, CA 92121
Do you want to be a contributor to the effort in eliminating the Coronavirus? Join this
innovative biotechnology company focused on the discovery, development, and commercialization of its synthetic DNA technology targeted against cancers and infectious diseases.
Essential job functions and duties
- Create high level system requirements with input from the design teams.
- Review, update and release documents written by the engineering team.
- Compile input from multidisciplinary stakeholders and generate documentation outlining Risk Analysis based on ISO 14971 guidelines.
- Write the system level V&V test plan and help the validation team with protocols and reports. · Work with engineers to create test protocols.
- Create the traceability matrix.
Job Description: The Senior Systems Engineer is the interface between all engineering disciplines to write both high level system requirements as well as lower level input requirements by working with individual engineers and others. The Senior Systems Engineer applies a multidisciplinary approach to ensure technical needs are translated into step-by-step processes. By working closely with all facets of engineering, as well as with the usability, regulatory, manufacturing, and quality functional areas, they will ensure alignment with cross functional teams to release documents in a timely manner. The Senior Systems Engineer is integral in compiling and documenting risk analysis information and creating the traceability matrix. The point person for ensuring documentation relating to engineering changes is reviewed, updated and finalized.
Salary Range and Bonus Potential:
$115,000 - $130,000 + bonus
- Robust Benefits Package
- Experience in the medical device regulated industry based on ISO 13485.
- Above average ability to relay technical information orally and write clear and concise documents for review by regulatory agencies.
- Good documentation, recordkeeping and data collection skills with attention to detail. Job Description Senior Systems Engineer
- Understanding of statistical sample size techniques to determine the appropriate amount of test samples.
- Excellent teamwork and interpersonal skills.
- Ability to work with minimal supervision.
- Familiarity with automated PLM tools e.g. Polarion is a plus.
- Bachelor’s degree in Systems, Electrical, Computer, Biomedical or Mechanical Engineering and a minimum 5 years of related experience; or an equivalent combination of education, training and/or experience from which comparable knowledge, skills and abilities have been attained.