Job Description
Sr Systems Engineer
MUST HAVE:
• Bachelor of Science in an Engineering (Systems, Biomedical, Electrical, Computer Science, Mechanical) discipline.
• A minimum of 3 to 7+ years of experience working as a Systems Engineer or with systems engineering responsibilities in a multidisciplinary project team environment.
• 2+ years of experience in leading a cross-functional development team.
• Demonstrated expertise in Systems Engineering practices such as requirements management, design trade-off and cost-benefit analysis, hazards and risk assessments.
• Experience with long term R&D development programs (concept/feasibility, development, commercialization).
• Experience in application lifecycle management tools (i.e. Polarion ALM, Helix ALM, Doors).
• Experience with root cause analysis and troubleshooting.
• Experience writing verification plans, protocols and reports in a regulated industry.
• Experience with data analysis (Minitab, JMP, or MatLAB).
• Proficient with Medical Device regulations (ISO 13485, ISO 14971, IEC 62304, 21 CFR part 820.30-Design Controls).
• Excellent project team skills; experience and capability working collaboratively under a Quality Management System (QMS), as part of a cross-functional team, such as development, verification/validation, manufacturing, marketing, clinical, regulatory and quality experts.
• Ability to communicate at multiple levels of an organization.
• Ability to organize and judge priorities in a dynamic environment.