Qualify alternate electronic and mechanical components based on technical specifications.
Create and review change impact documentation with technical assessments.
Lead cross-functional teams to ensure comprehensive technical evaluations and project success.
Serve as a Subject Matter Expert (SME) on technical matters and interface with senior management.
Complete documentation in a timely and compliant manner.
The role involves leading projects, working independently, and collaborating closely with R&D, Regulatory, Quality Assurance, Operations, and Global Sourcing teams.
Required Qualifications
Bachelor’s degree in Electrical Engineering (mandatory).
5+ years of relevant experience in the medical device industry.
Strong knowledge of cGMP, FDA, and ISO13485 standards.
Excellent written and verbal communication skills.
Extensive understanding of design and manufacturing processes for medical devices.
Top Skills
Electrical Engineering degree.
5+ years of experience in the medical device industry.
FDA/ISO13485 expertise.
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Engineering and Information Technology
Industries
Biotechnology Research, Medical Equipment Manufacturing, and Pharmaceutical Manufacturing
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