Are you an entrepreneurial, hands-on expert in FDA design controls for medical devices? Join a leading consulting firm that specializes in helping medical technology companies navigate regulatory requirements and establish quality management systems to launch and scale their products in the U.S.
In this key partnership role, you will:
Serve as the Design Controls Subject Matter Expert, guiding clients from concept to compliant, market-ready product
Provide hands-on engineering and design control expertise to help clients execute formal, systematic development processes
Co-develop and execute "turnkey development and launch" service packages for medical device companies
Drive business growth by partnering with the CEO to identify new clients and opportunities
Ideal candidates are skilled in FDA design control requirements, experienced in medical device development, and passionate about scaling a growing consulting practice. If you are excited about combining your technical expertise with an entrepreneurial spirit, let’s talk!