System Engineer II

At Smiths Medical, we are passionate about improving and saving the lives of patients through high quality, innovative medical devices and services. We are a leading global manufacturer of specialty medical devices that provides innovative and lifesaving solutions for the world’s healthcare markets.

The System Engineering team works across all Smiths Medical product franchises and is responsible for total life cycle management of product requirements, hazard analysis / risk management, design control and product validation practices. The System Engineering team partners with Product Management/Marketing, Functional engineering teams and Program Managers to translate customer and business needs, product hazards and clinical risks into engineering requirements, facilitates integration of functional development activities and drives top level validation activities for new product development. In addition, the team manages requirements change, design control and validation regression activities over the whole product life cycle.

The System Engineering team is responsible to develop, utilize and mature system engineering practices, tools and methodologies for executing the function of system engineering and to continually drive improvements in quality, productivity and speed to market for new products and product changes.

The System Engineer II responsibilities include creation, modification and management of requirements, hazard analysis and other top level design documents, as well as collaboration with other system engineers and/or cross-functional engineering peers in the design, development, maintenance and validation of new and existing medical devices.

Education and Experience

• Four-year degree in System, Biomedical or Mechanical Engineering, or other related field
• 3+ years product development and/or requirements and validation related experience

Technical Knowledge and Skills

• Medical Device compliant development methodologies (21 CFR 820, ISO13485) preferred
• Experience with design documentation creation and management including requirements and specifications.
• Experience with DOORS preferred.
• Broad critical thinking, decision making and judgment skills Strong interpersonal communications skills.