Overview
On Site
Full Time
Skills
Systems Design
Documentation
Task Analysis
Systems Analysis/design
FMEA
Usability
Exceed
Problem Solving
Conflict Resolution
Functional Requirements
Mechanical Engineering
Electrical Engineering
Biomedical Engineering
Design Controls
Risk Management
Medical Devices
Regulatory Compliance
Corrective And Preventive Action
Management
Communication
Job Details
Responsibilities:
- Ownership of design change projects including scoping, assessment, and implementation.
- Develop, update, and maintain Design History File and Design Input / Output documentation.
- Update and maintain risk management files, such as the Hazard Analysis, Task Analysis, and Design FMEA.
- Develop and execute Design Verification, Design Validation, and Usability protocols and reports to meet or exceed internal and external requirements.
- Provide design quality support in the resolution of PIRs, CAPAs, and NCEPs.
- pply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
- Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
- 3-5 Years with BS. Degree must be clearly stated on resume.
- Bachelor's degree in mechanical, electrical, or biomedical engineering, highly preferred.
- Experience with design control, risk management, and medical device standards compliance.
- Experience with corrective and preventive action.
- daptable and effective collaborator in a team environment and in self-directed work.
- Strong communication skills.
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