Systems Engineer (Medical Device)

The Systems Engineer will be part of a dynamic team within the Medical Device Practice. This engineering role will focus on providing engineering services including requirements development, failure analysis and reliability engineering services for SES's Medical, Pharmaceutical, and Consumer industry practices. Responsibilities of an individual in this role include but are not limited to:

• Drive day-to-day decisions to ensure robust products in compliance with regulatory bodies (such as the FDA)
• Lead customer engagement in areas such as systems architecture, system verification & validation activities while understanding and balancing system design objectives; in addition to the Medical Device Practice, this engineer will also work on engineering problems related to other industrial sectors such as consumer and industrial products
• Translate customer and technical design input requirements using systems engineering principles to develop system architecture and specifications with clear boundary conditions
• Work effectively with product design engineers (Mechanical, Electrical & Software Engineers) to achieve clients' objectives
• Support SES's practice growth by engaging in client sales and marketing activities
• Provide project support and guidance for project system testing and reliability subject matter expertise

• Experience leading a cross functional team required
• Must have the ability to understand project tradeoffs, interdependencies, and constraints
• Experience with reliability engineering methods including reliability/survivability statistics and Design of Experiments required
• Experience in managing the execution of complex systems engineering activities required
• Must be self-motivated, organized, and a problem solver who demonstrates knowledge of fundamentals but also has ability to view the "big picture”
• BS in Engineering (Mechanical, Electrical, Industrial or Biomedical) and 10+ years' experience; or MS in Engineering (Systems, Mechanical, Electrical, Industrial or Biomedical) and 8+ years' experience required
• Minimum 4 years' experience applying Product Development and Risk Management methodologies including FMEA, FTA and Risk/Hazard Analysis required
• Interest in client development and entrepreneurship to support in the growth of a team and organization preferred
• Previous Medical Devices product development or experience with structured and disciplined development processes preferred (e.g. U.S. FDA Quality System Regulation 21CFR Part 820, ISO13485, ISO9001, MDR EU 2017/745, IEC 60601, ISO 14971)
• Experience in the implementation of design control requirements and verification activities preferred
• Experience with tools such as Voice of the Customer, Critical to Quality, Quality Function Deployment and Failure Prediction Analysis preferred