Principal System Engineer

Full Spectrum•Westborough, MA

About The Position

Full Spectrum is a leading provider of product development solutions, including software and system development and testing services. We boast a 40-year history in successfully designing and developing over 1,000 FDA regulated medical devices and information systems, along with non-regulated solutions. As one of the earliest ISO 13485 certified software providers in the domain, Full Spectrum has a proven track record of helping our customers translate their business objectives into successful commercial products. Technology has never been more present in our lives than today. Everything from connected medical devices to robotics to mobile apps are becoming more a part of daily life. A career at Full Spectrum will allow you to be at the cutting edge of innovation. If it excites you to have direct involvement with the business-side of innovation and technological advancement by engaging with a diverse set of customers, then this is the place for you. We have a passionate team of experienced professionals who have first-hand experience developing products and solutions that create market value. Our clients depend on us to develop their next innovative product. Come help us build the future! Principal Systems Engineer: 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

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.
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 Haves

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