Design Control Engineer II

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.

#LI-remote All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. IDR is subject to certain governmental recordkeeping and reporting requirements for the administration of civil rights laws and regulations. In order to comply with these laws, we invite employees to voluntarily self-identify their race or ethnicity, gender, and veteran status (if applicable). Submission of this information is voluntary and refusal to provide it will not subject you to any adverse treatment. The information obtained will be kept confidential and may only be used in accordance with the provisions of applicable laws, executive orders, and regulations, including those that require the information to be summarized and reported to the federal government for civil rights enforcement. You may access this form here.