Director - Electronics Hardware
Sullivan & Cromwell LLP
Design Quality Engineer III, Medical Device
Pharmavise Corporation
contract
Posted on:
Origin: • 🇺🇸 United States
Visit company websiteJob Level
Mid-LevelSenior
About the role
- Support application of design controls for projects focusing on design changes, material continuity, regulatory and standards compliance, corrective and preventive actions, and manufacturability/cost reduction.
- Ownership of design change projects including scoping, assessment, and implementation.
- Develop, update, and maintain Design History File and Design Input / Output documentation.
- Develop, update, and maintain risk management files such as Hazard Analysis, Task Analysis, and Design FMEA.
- Develop and execute Design Verification, Design Validation, and Usability protocols and reports to meet internal and external requirements.
- Provide design quality support in the resolution of PIRs, CAPAs, and NCEPs.
- Apply systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues.
- Build quality into all aspects of work by maintaining compliance to all quality requirements.
- Collaborate with cross-functional team (team of 5 Design Assurance engineers; total team of 20).
- Focus on imaging diagnostic catheter design changes.
Requirements
- Bachelor’s degree in an engineering discipline
- 5+ years of work experience (5 - 7 years with BS; 3 - 5 years with MS)
- Experience in design assurance, quality, or related medical device or regulated industry
- Medical device experience preferred
- Must have worked in a regulated space
- Design quality experience
- Design assurance experience
- Risk management experience (Hazard Analysis, Task Analysis, Design FMEA)
- Experience developing/executing Design Verification, Design Validation, and Usability protocols and reports
- Experience supporting PIRs, CAPAs, and NCEPs
- Good problem-solving ability
