Design Control Consultent

Role/Day To Day

This role is heavily documentation-focused and will support the engineering teams by owning design controls, DHF execution, and document management across multiple devices and suppliers.

They are looking for a quality-savvy professional who thrives in complex medical device programs and enjoys taking ownership of design control documentation from draft to approval.

• Execute and support medical device design controls
• Create, update, and maintain Design History Files (DHF) and FMEAs
• Support design verification, design reviews, and required documentation
• Draft, revise, route, and drive documents through approval
• Reduce documentation burden on engineering teams
• Work within Adaptiv (current system); support transition to Windchill
• Coordinate documentation across engineering, suppliers, and program leadership

Skills Needed

• Bachelors or above
• 5-10 years medical device design control and documentation experience
• Strong hands-on experience with DHFs, design reviews, and design verification
• Regulated medical device documentation experience
• Able to function as both a design history file, design control SME and documentation specialist
• Comfortable supporting complex programs
• Experience with Windchill, Adaptiv nice to have
• Knowledge of CE marks for medical devices
• Combination products - nice to have

EOE Statement

Specialist Staffing Group is an equal opportunity employer.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.