This position supports product leadership and risk management of new product development and sustaining activities within a global medical technology company
Job Summary
This position supports product leadership and risk management of new product development and sustaining activities within a global medical technology company.
Responsibilities include leading development of risk assessments, test methods, component qualifications, design validation/verification, and process validation.
The role requires representation on Product Development Teams, support for regulatory submissions, and compliance with company procedures and government regulations.
Matching Summary
This position supports product leadership and risk management of new product development and sustaining activities within a global medical technology company.
Skills & Requirements
Must-have
Risk management and assessment
Test method development and validation
Component qualification
Design validation and verification
Process validation
ISO 13485 and ISO 14971 compliance
Nice-to-have
Team-oriented, fast-paced environment
Strong interpersonal skills
Problem solving ability
Ability to create and provide training
Key Requirements
BS in Engineering
0-2 years' experience in engineering or Quality engineering
Experience in medical device, pharmaceutical, or equivalent industry