The Sr. Systems Engineer will be responsible for translating user and business needs into system and subsystem requirements, system-level design, architecture definition, and integration of complex electro-mechanical systems with software.  The engineer is experienced in all aspects of product development life cycle with strong background in systems engineering processes and reliability engineering in a regulated industry.  The Sr. Systems Engineer will work with a multi-disciplinary engineering team including mechanical, electrical, and software engineers, and other functions to ensure high quality product introductions for class II medical devices.  We are looking for a motivated self-starter who is energetic, has a ‘make it happen’ attitude and can thrive in a fast-paced environment. 

Main Areas of Responsibilities: 

• Within the Product Development team lead the systems engineering and reliability engineering activities for complex electro-mechanical medical devices.

• Translate customer needs, research findings and business requirements into product requirements and specifications. 

• Develop and maintain system product specifications, requirements documents, product use cases, product usage model, hazards analysis, Design FMEA, and Use FMEA, design V&V documentation, and other technical documentation.

• Develop, manage, and execute Design for Reliability (DFR) activities that identify sensitivities and failure processes. Leverage test strategies and Design of Experiments for efficient coverage of complex parameter spaces and physics of failure analysis.

• Develop analytical methods to determine reliability of components, subsystems, and the overall product. Acquires and analyzes data. Prepares charts, drawings, calculations and reports to define reliability problems and make recommendations for improvements.

• Lead teams through complex root-cause analysis in which there are many possible root causes. Mentor others on systematic best practices for problem solving.

• Ensure system design and appropriate supporting documentation meets all safety and regulatory and industry compliance standards and codes.

• Communicate and collaborate with a wide range of project contributors and stakeholders spanning the organization, and external partners.

• Collaborate with technical leaders for product design, development, integration, testing, and reliability improvements.

Must have a Bachelors of engineering or science. Post graduate degrees in Engineering is desired.

• A strong technical background within Systems Engineering, Reliability engineering, medical device development, or similar.

• 10 years of experience in regulated industry working on complex electromechanical systems.

• Experience and / or curriculum in Reliability Engineering.  Experience with reliability simulation software.

• Experience in experimental techniques, statistical analysis, and engineering investigation techniques.

• Experience with Design for Six Sigma (DFSS) and critical parameter management.

• Strong understanding of Design Controls for medical device development.  Experience with medical device design and development processes that conform to standards including: ISO 9000, ISO 13485, IEC 62304, IEC 60601, IEC 62366, and ISO 14971.

• Technical leadership or program management experience.  Strong understanding of project/program management with an understanding of the FDA product development process. 

• Demonstrated experience in driving design for manufacturability and service.

• Experience in using requirement management and Traceability tools such as Polarion, Jama, DOORS, etc.