Role: Senior Design Verification Lead
Location: Ball ground, GA (Hybrid)
Exp - 12+
Must Haves:
1) Medical Device Systems Engineering
2) Requirements Engineering & Statistical techniques
3) Verification & Validation Experience for Class II & Class III Medical devices
Job Description:
•Act as the primary liaison to the organization for all design verification activities.
•Serve as the domain expert on verification processes, standards, and statistical methods.
•Oversee the entire design verification process, ensuring alignment with company goals and FDA requirements.
•Provide strategic guidance for test method development, fixtures, and equipment validation.
•Lead critical investigations, defect resolution processes, and risk management activities.
•Influence organizational practices by driving continuous improvement in design verification methodologies.
•Mentor engineers across all levels and provide technical training as needed.
Competencies:
•12+ years of experience in design verification, with extensive medical device expertise.
•Proven track record as a technical leader and subject matter expert.
•Strong communication skills to interface with regulatory bodies and cross-functional teams.
•Advanced knowledge of statistical techniques, including hypothesis testing and variance analysis.