Principal Systems Engineer / Team Lead

Principal Systems Engineer / Team Lead

This position requires knowledge and experience in driving Systems Engineering on multiple engineering projects. This Principal position requires direct customer interface and the leadership to manage a project and delegate tasks, based on agreed to client needs to other team members. This position requires in-depth knowledge of system engineering skills including:

• Safety Risk Analysis- Proficient with planning system risk analysis for complex medical devices (that contain software), understand and identify potential harms and hazards leading to harm, ability to perform bottom-up failure analysis (FMEA). Practical experience applying risk over the lifecycle.
• Project and V&V Leadership- Experience in iterative development, understand key tasks and typical medical device documentation. Proficient in V&V strategy, V&V planning software V&V approaches. Methodology in test development which includes test planning, design, and test case creation
• Requirements Management- Practiced experience in developing and implementing requirement structure schema and hierarchy using requirement management tools, proficient in requirement allocation and the ability to correctly trace and develop requirement trace matrices. Experience with requirements elicitation from the clients around the end users of medical devices. The ability and skill of requirements elaboration which takes the user needs and translates them into system and software design requirements
• Compliance Engineering- Familiar with key Standards/FDA guidance for medical devices that contain software that impact the development process and impact the product design. Standards such as IEC60601-1, IEC62304, ISO14971, IEC62366, IEC60601-1-8 and FDA regulation 21 CFR part 820, FDA guidance including GPSV, design control guidance and the software submission guidance
• Software Testing strategy experience- Understanding of software lifecycle/IEC62304, including unit, to system to GUI testing
• Cybersecurity process and compliance - experience and understanding of typical tasks and documentation needed to support FDA compliance

Must Have: Minimum Requirements:

• Experience working in Systems Engineering and the application of tasks to address system safety analysis, requirements management, project management concepts and experience with compliance and cybersecurity processes.
• Leadership experience in medical device development. Having responsibility to define activities, identify project risks and communicate clearly with project team members.
• This role provides training and real-time guidance and problem solving with engineers working in the Software Test realm, especially with respect to understanding the documentation requirements expected in the regulated environment. Consultation with the Test Process owners on changes to the process while minimizing audit exposure.
• Familiarity with IEC 13485; ISO 14971; ISPE GAMP-5; 21cfr820; ISO/TIR 80002-2; AAMI TIR-32; General Principles of Software Validation; Final Guidance for Industry and FDA Staff (2002); IEC60601-1. This position is expected to remain aware of changes in these documents and trends in the industry via monitoring of Corporate Standards work and industry news.
• An understanding of software risk process (such as IEC62304, TIR-32, TIR80001) and strong familiarity with both design and process risk models (from ISO14971) is needed to sort out and control the various risks possible at Test.
• Solid background in Electrical and familiarity with basic Mechanical engineering. Familiarity with Medical Device design and manufacturing. Familiarity with electrical test, both in instrumentation and software interactions.

Educational Requirements:

• Bachelor's Degree in Software or Electrical or Computer engineering or related science discipline and minimum of 8 years relevant experience (advanced degree in Engineering / Science discipline a plus).

Nice to Have:

• Minimum 4 years of Software development experience using these Skills, Languages, Tools, Platforms & Methodologies.
• C/C++ expertise
• SW Design and Architecture
• Experience with Machine Learning systems and management of algorithms
• Real-Time & Embedded Programming vs. Application Programing
• Object Oriented Programming concepts and experience

Good understanding of design controls and regulatory compliance.

Experience with technical documentation in a regulated industry

• Prior work in a regulated environment and medical software development experience following development standards and processes
• Clear Understanding of regulatory requirements with Regulatory Affairs partners, regulatory strategy, system intent and launch strategy
• Self-starter with strong work ethic and initiative in accomplishing objectives
• Familiarity with Agile methodology & Version Control