At Spacelabs Healthcare, we are on a mission to provide continuous innovation in healthcare technology for better clinical and economic outcomes. Our scalable solutions deliver critical patient data across local and remote systems, enable better-informed decisions, increase efficiencies, and create a safer environment for patients.
Why work at Spacelabs? Because lives depend on you!
The Senior Systems Engineer will be a member of the Spacelabs Engineering team working in the development and support of Spacelabs Patient Monitoring and Connectivity products. Senior Systems Engineers are expected to work with other cross-functional members of the engineering staff to provide technical systems level expertise and solutions to engineering problems. The Senior Systems Engineer will work with various department function leads and project engineers in establishing product requirements and systems architecture, and will collaborate with the various engineering disciplines in creating or reviewing mechanical and electrical hardware designs, firmware and software designs, project schedules, test plans, and other project documentation from the concept phase through successful product launch.
- Works with the various engineering disciplines to translate market-driven requirements into Product Requirements and ultimately flow them down into lower level hardware and firmware requirements or technical specification documents.
- Leads the requirements development, systems level architecture design and external communications/connectivity interface designs by collaborating with cross-functional disciplines within and outside Engineering.
- Participates as a member of systems project or sub-project team(s) in developing product system requirements and architectures. May act as technical lead on assigned programs.
- Works with program core team members including Quality and Regulatory to ensure conformance to established design development processes and procedures.
- Works with program managers to create and manage project deliverables and schedules.
- Leads and facilitates architectural and design decisions to ensure on-time delivery of projects.
- Escalates resource and technical issues in a timely fashion to Engineering leadership.
- Responsible for ensuring 100% requirement to V&V test plan coverage on programs.
- Leads FMEA discussions at all levels to ensure product quality and reliability.
- Leads functional process and tool improvement initiatives by being early adopter of ideas on projects without affecting project schedules.
- Functions well in a team environment. Gains consensus, leads, influences and ensures cross-discipline participation and feedback.
- Demonstrates 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.
- Bachelor of Science degree in Electrical, Mechanical, Biomedical, Computer Engineering, Computer Science, or similar related degree. Master’s degree is desirable.
- 5+ years’ experience in a Systems Engineering Role of which as minimum of 2 years in the medical device industry.
- Familiar with systems engineering processes, in particular establishing design inputs and top down design using system requirements methodologies.
- 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 processesassociated 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 travelinternationally and be able to acquire all necessary travel documents. Travel up to 10%.
Equal Opportunity Employer