Design Controls Specialist
6 days ago
Job Summary
A system engineer with 5-8 years of experience in the medical device industry is required to lead the design controls, traceability, and validation efforts. The role involves translating user needs into product requirements and documenting them throughout the product development lifecycle.
Key Responsibilities
- Develop and implement design control processes in compliance with FDA (21 CFR 820) and ISO 13485 regulations.
- Ensure traceability between user needs, design inputs, verification, and validation activities.
- Collaborate with cross-functional teams to ensure design validation aligns with user expectations.
- Maintain and update Design History Files (DHF) and other required documentation.
- Prepare and maintain design control documentation for compliance audits.
- Identify process improvement opportunities in design control and traceability methods.
Personal Attributes
- Strong analytical and problem-solving skills.
- Detail-oriented with a focus on regulatory compliance.
- Ability to work independently and collaboratively in a fast-paced environment.
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