Systems Engineer, Senior

Essential Duties And Responsibilities

• Lead cross-functional technical teams in delivering medical devices from initial customer requirements through implementation.
• Serve as the primary technical point of contact to the customer.
• Define system architecture and maintain accountability for system design documentation.
• Lead the evaluation of design alternatives and tradeoff analyses across multiple technologies and engineering disciplines.
• Lead the definition, analysis, and allocation of requirements derived from customer and user needs.
• Oversee risk management activities, including design failure modes and effects analysis (DFMEA).
• Serve as the project’s primary technical authority on applicable medical industry standards.
• Partner with the test engineering team to define procedures that verify system requirements.
• Cook up and manage third-party engagements, including outsourced design activities and testing services.
• Coordinate and manage third-party engagements, including outsourced design activities and testing services.
• Lead schedule development and budget estimation for new project opportunities.
• Provide mentorship and technical guidance to less experienced engineers.
• Lead and support continuous improvement initiatives across engineering processes.

Qualifications

• Bachelor’s or Master’s degree in Systems, Software, Electrical, or Mechanical Engineering.
• 6-9 years experience in developing software and/or electronic-based medical devices.
• Demonstrated complete understanding and wide application of technical principle, theories, and concepts in the field of medical devices; general knowledge of other engineering disciplines.
• Proficient at quickly solving medium-complexity system-level problems.
• In depth knowledge of FDA QSR’s, ISO 13485, and IEC 60601 for medical devices.
• Experience in interpreting and applying technical regulatory requirements to medical devices.
• Strong interpersonal, communication (both written and oral) & analytical skills.
• Excellent interpersonal skills with multiple disciplines & clients.
• Able to work independently, but also function as a team player.

Pay

The expected starting salary for this position is $120,000 to $155,000 depending on qualifications. As part of your overall rewards, we offer a comprehensive benefits program.