Senior Systems Engineer - Medical Devices Lead

Gardner Resources Consulting, LLC; Lexington (MA); On-site; USD 80,000 - 120,000; Full time

Job summary

A consulting firm is seeking a Systems Engineer in Massachusetts with a Bachelor's in Engineering and 3-7 years of experience. Responsibilities include leading cross-functional teams and managing systems engineering practices within a regulated environment. Candidates should have expertise in writing verification reports, data analysis tools, and familiarity with medical device regulations. This role demands excellent communication skills and the ability to prioritize in a dynamic setting.

Qualifications

• 3 to 7+ years of experience in Systems Engineering or related responsibilities.
• Proficient in regulatory standards like ISO 13485, ISO 14971.
• Experience writing verification plans and reports.

Skills

Systems Engineering practices

Cross-functional team leadership

Data analysis

Root cause analysis

Communication skills

Education

Bachelor of Science in Engineering

Tools

Polarion ALM

Helix ALM

Minitab

JMP

MatLAB

Job description

A consulting firm is seeking a Systems Engineer in Massachusetts with a Bachelor's in Engineering and 3-7 years of experience. Responsibilities include leading cross-functional teams and managing systems engineering practices within a regulated environment. Candidates should have expertise in writing verification reports, data analysis tools, and familiarity with medical device regulations. This role demands excellent communication skills and the ability to prioritize in a dynamic setting.