Bella Currin

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.