Senior System and Test Engineer

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 engineering driven innovation. If it excites you to develop new products and learn new technologies on a regular basis from 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. Our clients are dependent on us to develop their next innovative product to bring to market. Come help us build the future, come join Full Spectrum!

Senior Systems and Test Engineer:

The Senior Systems Engineer is a position responsible for the requirements, integration, analysis and verification of complex systems. This position requires knowledge and experience in Systems Engineering core competencies including requirements development, architecture definition, safety risk analysis, technical risk management, and verification / validation in a regulated environment. This position will have a direct customer interface role that requires strong communication skills to build alignment with the client. This position requires the ability to execute tasks independently while providing strong team contributions. The successful candidate will have good communication and critical thinking skills.

Responsibilities:

o Requirements Development: Experienced in traditional system engineering practices including requirements elicitation from the clients around the end users of medical devices and other products. Ability to translate user needs into technical system and software requirements.

o Requirements Management: Experienced and practiced in developing and implementing a schema for requirements structure and hierarchy using requirement management tools. Proficient in requirement allocation and the ability to correctly trace and develop requirement trace matrices

o Safety Risk Analysis: Experience with risk analysis for complex medical devices (that contain software). Ability to understand and identify potential harms and hazards leading to harm, ability to perform bottom-up failure analysis (FMEA)

o Interface Analysis: Ability to analyze key interfaces of a complex product. Includes functional and communication with software support and the identification of key interfaces.

o Compliance Engineering: Familiar with key Standards and FDA guidance for medical devices that contain software. Standards such as IEC60601-1, IEC62304, ISO14971, IEC62366, IEC60601-1-8 and FDA regulation 21 CFR part 820. FDA guidance including software validation, design control guidance, and the software submission guidance.

o V&V: Experience in developing V&V strategy and planning. Familiar with software V&V approaches. Methodology in test development which includes test planning, design, and test case creation.

o Test Case Development: Software and system level Test case development experience, strong experience in execution of tests, good documentation practice and report writing.

o Process Improvement: Contribute to the continuous improvement of systems engineering practices.

o Compliance: Knowledgeable in compliance / FDA standards. Remain aware of changes in these documents and trends in the industry

Preferred Experience:

o Bachelor’s Degree in Software or Electrical or Computer engineering or related science discipline; advanced degree in Engineering / Science discipline a plus

o 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.

o Experience in software quality engineering and Computer system Validation in a regulated environment.

o Experience with the software risk process (based on TIR-32, TIR80001) and strong familiarity with both design and process risk models (from 14971)

o Familiarity with Medical Device design and manufacturing. Familiarity with electrical test, both in instrumentation and software interactions.

Knowledge, Skills and Abilities:

o Requirements management for software requirements and or system requirements

o Basic system architecture definition

o Risk analysis experience, FMEA’s, risk management plans

o V&V planning experience

o Requirements management tool experience such as DOORS, JAMA, Catapult or Helix

o Understanding of software Development lifecycle and Agile development

o Familiar with IEC62304, IEC60601-1, IEC60601-2, ISO14971, IEC62366

o Performance test design and Statistical analysis

o Experience with issue tracking process and workflows

o Advanced architecture and interface analysis (such as N2)

o Experience with software and hardware configuration management

o Familiar with Design for X (DFX) fundamentals

o Travel: Ability to travel locally, 10% of the time.

Full Spectrum is a leading provider of software and system development and testing services. We boast a 40-year history in successfully designing and developing over 1,000 Class I, II, and III medical device and non-medical 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.