You will participates as a member of systems project or sub-project team(s) in developing product systems architectures. May act as technical lead on assigned programs.
You will works with program core team members including Quality and Regulatory to ensure conformance to established design development processes and procedures.
You will works with the various engineering disciplines to translate market-driven requirements into technical specifications, and ultimately flow them down into lower level hardware and firmware requirements documents.
You will leads the requirements development, systems level architecture design and external communications/connectivity interface designs by collaborating with cross-functional disciplines within and outside R&D.
You will works with program managers to create and manage project 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 R&D leadership.
You will be responsible for ensuring 100% requirement to Verification/Validation test plan coverage on programs.
You will leads FMEA discussions at all levels to ensure product quality and reliability.
You will leads functional process and tool improvement initiatives by being early adopter of ideas on projects without impacting project schedules.
B.Sc. Electrical/Software/BioMedical Engineering
3+ years systems engineering experience in industry.
Experience as a systems / product support engineer in a regulated industry (i.e. medical, aeronautics, nuclear, etc.).
Familiar with systems engineering processes, in particular establishing design inputs and top bottom design using system requirements methodologies.
Familiar with risk management techniques (i.e. Failure Modes and Effects Analysis – FMEA).
Familiarity with and working knowledge of automated requirements traceability tools, such as Polarion, Doors , etc.
Extensive experience in software development and software architecture. 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.
Good communication and interpersonal skills.
Able to collaborate across technical and non-technical disciplines. Good team player.
Medical device design and development
M.Sc. / M.E Biomedical Engineering / Master of System Engineering