Sr Systems Engineer

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

Qualifications

• 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.