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IDR is seeking a Design Control Engineer II to join one of our top clients for an opportunity in Indiana. This role focuses on managing post-market activities for medical devices, ensuring compliance and maintaining Design History Files in a regulated environment.
Position Overview for the Design Control Engineer II:
- Responsible for post-market activities of existing Design History Files for medical devices under the direction of a project leader or manager.
- Utilize Vault systems to manage documentation workflows and ensure compliance with regulatory standards.
- Collaborate with cross-functional teams to conduct design reviews and update risk documentation.
- Generate protocols for product testing, verification, and validation to support device safety and effectiveness.
- Maintain and update design and manufacturing documentation ensuring accuracy and completeness.
Requirements for the Design Control Engineer II:
- Familiarity with Vault Systems.
- Experience with drafting standards and geometric dimensioning and tolerancing (GD&T).
- Strong background in DHF documentation authoring and execution for medical devices.
- Ability to work effectively within a team to complete critical project tasks across Regulatory and Quality groups.
- Proven ability to establish process methods that meet performance and quality requirements.
What's in it for you?
- Competitive compensation package
- Full Benefits; Medical, Vision, Dental, and more!
- Opportunity to get in with an industry leading organization.
Why IDR?
- 25+ Years of Proven Industry Experience in 4 major markets
- Employee Stock Ownership Program
- Dedicated Engagement Manager who is committed to you and your success.
- Medical, Dental, Vision, and Life Insurance
- ClearlyRated's Best of Staffing® Client and Talent Award winner 12 years in a row.