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.