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Sr. Principal Engineer
Ref No.: 18-08389
Location: Round Lake, Illinois
Start Date / End Date: 07/23/2018 to 07/22/2019
Design Remediation Sr. Principal Engineer
Department: Medical Disposable Device

This position will function as Product Design Owner (PDO) / Subject Matter Expert (SME) along under the current PDO/SME in a Design History File Remediation effort for Disposable Medical Products. Primary focus will be on requirements remediation, identification of verification gaps, and rationalization and/or testing to fill those gaps.
1. Responsible for developing and updating Technical/Design documentation.
2. Product design & Development support.
3. Develop DHF gap assessment & Improvement plan
4. Develop verification/validation protocols and reports.
5. Familiar with manufacturing documents (BOM, Assembly Drawings, specifications, manufacturing procedures, etc.)
6. Coordination with Project Manager and offshore Project lead to ensure for smooth project flow.
7. Participate in weekly status review meeting with PM and offshore team.
8. Tracking and escalating delays in getting approvals/information from cross functional team.
9. Address the help needed from offshore team.
1. Knowledge of Design History File elements (Requirements, Verification, Validation, Design Outputs, etc.)
2. Current knowledge of FDA, ISO, CE Mark, and other regulatory requirements related to R&D, product development, design and safety to ensure compliance in all research, data collection and reporting activities.
3. Good understanding in functional / system test for medical / non-medical devices
4. Medical device experience, Product development, V&V experience
5. Experience in writing protocols and reports
6. Experience in Verification, Validation & Test method validation process & execution.
Education / Experience
Education requirement:
Bachelors of Science in Engineer required, Master-strongly preferred.
# of year of experience: 8-10 years recent, relevant design remediation experience
Software skills: MS Word, Excel (pivot tables, v-lookups), PowerPoint, Outlook, & SharePoint, Doors (preferred), Statistical software (preferred), etc.
Industry Experience: Medical Device preferred, other regulated industries like Aerospace & Automotive will be considered.

Interview Platform: phone followed by onsite appointment