Role: Senior Design Verification Lead
Location: Ballground, GA (onsite/Hybrid)
Contract
Must Haves:
1) Medical Device Systems Engineering
2) Requirements Engineering & Statistical techniques
3) Verification & Validation Experience for Class II & Class III Medical devices
Nice to Have/Additional Comments:
Job Description:
Essential Functions:
•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.
Work Environment
This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets, and audio/visual equipment.
Physical Demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
While performing the duties of this job, the employee is regularly required to sit; use hands to finger, handle or feel objects, tools or controls and talk or hear. The employee is occasionally required to stand, walk, stoop, kneel, crouch or crawl. Specific vision abilities required by this job include close vision and the ability to adjust focus.
Travel
•Ability to travel up to approximately 20%, including internationally.
Required Education and Experience
•Biomedical Engineering, Computer Science, Computer Engineering, Mechanical Engineering, Electrical Engineering, or a related field.