Remote Design Controls Specialist – Medical Devices

Real; Blue Ash (OH); On-site; USD 90,000 - 150,000; Full time

Job summary

Specialist Staffing Group is seeking a Design Control Consultant for a fully remote role in the medical device sector. The position focuses on owning design controls, DHF execution, and meticulous document management across multiple devices and suppliers.

The candidate will draft, revise, and route documents through approval, support design verification and reviews, and assist with transitioning from Adaptiv to Windchill, collaborating with engineering teams and leadership.

Qualifications

• 5-10 years medical device design control and documentation experience.
• Experience with DHFs, design reviews, and design verification.
• Able to function as a design history file, design control SME and documentation specialist.
• Knowledge of CE marks for medical devices and combination products is a plus.

Responsibilities

• Execute and support medical device design controls.
• Create, update, and maintain DHF and FMEAs.
• Support design verification, design reviews, and required documentation.
• Draft, revise, route, and drive documents through approval.
• Work within Adaptiv; support transition to Windchill.
• Coordinate documentation across engineering, suppliers, and program leadership.

Skills

5-10 years design control

DHF execution

Documentation management

DHF SME

Complex programs

Windchill knowledge

Education

Bachelor's degree or higher

Tools

Windchill

Adaptiv

Job description

Specialist Staffing Group is seeking a Design Control Consultant for a fully remote role in the medical device sector. The position focuses on owning design controls, DHF execution, and meticulous document management across multiple devices and suppliers.

The candidate will draft, revise, and route documents through approval, support design verification and reviews, and assist with transitioning from Adaptiv to Windchill, collaborating with engineering teams and leadership.