This role supports product leadership and risk management for new product development and sustaining activities for combination products within a global medical technology company
Job Summary
This role supports product leadership and risk management for new product development and sustaining activities for combination products within a global medical technology company.
The position requires extensive experience in creating, reviewing, and investigating analytical test methods while leading component qualifications and design validation efforts.
Candidates must possess strong interpersonal skills to lead cross-functional teams and make risk-based decisions while ensuring compliance with corporate and industry standards.
Matching Summary
This role supports product leadership and risk management for new product development and sustaining activities for combination products within a global medical technology company.
Skills & Requirements
Must-have
8+ years medical device or pharma experience
Design controls and validation expertise
Risk assessment and root cause analysis
Test method development and validation
ISO 13485 and ISO 14971 knowledge
21 CFR 210/211/820 regulatory compliance
Nice-to-have
ASQ Quality Engineering Certification
Cross-functional team leadership skills
Strong presentation and communication abilities
Experience with combination product submissions
Supplier audit coordination experience
Key Requirements
BS in Engineering, Biological Science, or related field (Masters/PhD preferred)
Minimum 8 years of engineering or quality engineering experience
Proven understanding of design controls in the development stage
Pharmaceutical or combination product experience required
Working knowledge of ICH Guidelines and FDA regulations