Sr. Systems Engineer

Job Title: Sr. Systems Engineer Location: Lexington, MA (Hybrid) local only Type: Contract

GC, USC

Video Interview but can ask for onsite

Systems engineering expertise with 3–7+ years experience, leading cross-functional teams, requirements management, risk assessment, R&D program experience, regulated industry compliance (ISO 13485, ISO 14971, IEC 62304, 21 CFR 820), and proficiency with ALM tools (Polarion, Helix, DOORS).

Job Description: Gardner Resources Consulting, LLC is seeking a Sr. Systems Engineer to support CVS Health's regulated medical device and clinical technology initiatives. The ideal candidate will have strong experience in systems engineering within R&D or regulated industries, leading cross-functional teams, and ensuring compliance with medical device standards.

Responsibilities

• Lead systems engineering efforts on multidisciplinary project teams.

• Manage requirements, perform design trade-offs, cost-benefit analyses, and risk assessments.

• Oversee long-term R&D programs from concept through commercialization.

• Develop verification plans, protocols, and reports in compliance with medical device regulations.

• Utilize application lifecycle management tools (Polarion ALM, Helix ALM, DOORS).

• Conduct root cause analysis, troubleshooting, and data analysis (Minitab, JMP, MATLAB).

• Collaborate under a Quality Management System (QMS) with development, verification/validation, manufacturing, regulatory, and clinical teams.

• Communicate effectively across organizational levels and manage project priorities in a dynamic environment.

• Required Qualifications:

• Bachelor of Science in Engineering (Systems, Biomedical, Electrical, Computer Science, Mechanical).

• 3–7+ years of experience as a Systems Engineer in multidisciplinary project environments.

• 2+ years of experience leading cross-functional development teams.

• Expertise in systems engineering practices, including requirements management and risk assessments.

• Experience with long-term R&D development programs and regulated industry compliance.

• Proficient with medical device standards (ISO 13485, ISO 14971, IEC 62304, 21 CFR part 820.30 – Design Controls).

Preferred Qualifications

• Experience with application lifecycle management tools (Polarion, Helix, DOORS).

• Advanced data analysis skills and familiarity with verification documentation.