Warsaw, Indiana, United States
IDR is seeking a Design Control Engineer to join one of our top clients for an opportunity in Warsaw, Indiana. This role is involved in the post-market activities of medical device design files and documentation, supporting regulatory compliance efforts within the medical device industry.
Position Overview for the Design Control Engineer:
- Responsible for managing the post-market activities of existing Design History Files for medical devices under the guidance of a project leader or manager.
- Utilize Vault systems to author, review, and manage design documentation, ensuring compliance and completeness.
- Collaborate with cross-functional teams to conduct design reviews, risk analysis, and verification and validation protocols.
- Perform functional relationship analyses and generate/update design and manufacturing documentation.
- Support the organization’s quality and regulatory compliance by maintaining accurate and thorough design control records.
Requirements for the Design Control Engineer:
- Familiarity with Vault Systems and document management workflows.
- 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 cross-functional teams including Regulatory and Quality.
- Excellent communication, teamwork, and organizational skills, with self-motivation and initiative.
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.
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