Responsibilities:

• Work with the various engineering disciplines to translate market-driven needs into product requirements and ultimately flow them down into lower level hardware and firmware requirements or technical specification documents.
• Lead the requirements development, systems level architecture design and external communications/connectivity interface designs by collaborating with cross-functional disciplines within and outside R&D.
• Work with program core team members including Quality and Regulatory to ensure conformance to established design development processes and procedures.
• Responsible for ensuring 100% requirement to V&V test plan coverage on programs.
• Lead FMEA discussions at all levels to ensure product quality and reliability.
• Function well in a team environment. Gains consensus, leads, influences and ensures cross-discipline participation and feedback.
• Demonstrate good design practices and methodologies.
• Uphold the Company's core values of Integrity, Innovation, Accountability, and Teamwork.
• Demonstrate behavior consistent with the Company's Code of Ethics and Conduct. Ensure that team members (direct or indirect reports) are trained and evaluated on their knowledge and adherence to the Company's values, Code of Ethics and Conduct, and applicable compliance policies.
• It is the responsibility of every Spacelabs Healthcare employee to report to their manager or a member of senior management any quality problems or defects in order for corrective action to be implemented and to avoid recurrence of the problem.
• Duties may be modified or assigned at any time to meet the needs of the business.
  
  Qualifications:

• Bachelor of Science degree in Electrical, Mechanical, Biomedical, Computer Engineering, Computer Science, or similar related degree. Master's degree is desirable.
• 8+ years' relevant systems engineering and/or cybersecurity engineering experience, of which as minimum of 3 years in the medical device industry.
• Experience with systems engineering processes, in particular establishing design inputs and top down design using system requirements methodologies.
• Must have familiarity with security standards and frameworks including NIST 800-53, NIST CSF, NIST 800-171, IEC 80001, and/or ISO 27001/5, and/or US government ATO processes.
• Experience performing Threat, Exploit, and Vulnerability analysis of products and systems. Familiarity performing and reporting vulnerability testing of software and systems.
• Familiar with one or more risk management techniques (i.e. Hazard Analysis, Risk Analysis, Failure Modes and Effects Analysis (FMEA), Fault Tree Analysis (FTA), etc.).
• Familiarity with and working knowledge of automated requirements traceability tools, such as Rational RequisitePro, IBM Doors, Rational Quality Manager, etc.
• Experience in an Agile Software Development Environment will be a plus.
• Candidate should be knowledgeable and have experience in hardware and firmware development and the processes associated with product life cycles, such as stage/phase gate product development processes.
• Able to work, influence and lead in a highly cross-functional team environment.
• Familiarity with FDA Quality Systems Regulations (QSR) preferred.
• Excellent communication and negotiation skills, for both internal and external audiences, at all levels.
• Knowledge of and ability to work within a global corporate environment is required.
• Must travel internationally and be able to acquire all necessary travel documents. Travel up to 10%.