Principal Systems Engineer
Our client is a global leader in
diagnostic solutions with a dedication to quality product development to
enhance patient care. In this position, you will play a key role in planning,
conducting and evaluating work to support manufacturing, software, and products
and you will maintain timelines and objectives to procedures and product
development while mentoring junior staff.
- Accountable for documentation of
design controls, methods while making adjustments to align with the
- Analyzes and interprets data,
identifying trends and formulating the next steps, while effectively
performing trade off analysis, if required by the function.
- Leads, designs and/or develops
one or more of the following: new test methods, specifications, technical
apparatus, software and processes for complex components and functions.
- Recommends design options,
presents tradeoffs, and helps with risk-based decision making. Evaluates
complex designs or processes.
- Identifies issues in product
development and authors documentation to support continuous improvement.
- Provides technical support and
leadership for CAPA and/or complaint investigations.
- BS or MS in relevant discipline
such as Engineering, Mechanical, or Biomedical
- 8 + years of related experience
in product development in the medical device industry
- Expertise in the application of
Statistical Analysis, Test Method Development, Design Control, and
- Technical Leadership, including
strong communications, presentations, problem solving, coaching, and
guiding technical teams