12 Month Contract (May extend or convert to permanent)
Some hybrid flexibility, depending on onsite testing needs
$38/hour W2
Must Have Requirements:
- Degree in Engineering or Computing Field.
- Medical Device Industry experience and regulated work environment experience.
- Strong understanding and experience in design controls, failure investigation (leading an investigation).
- Experience with technical evaluations and root cause analysis.
- Ability to clearly communicate with diverse teams, including Engineering, Manufacturing, Regulatory, and Quality colleagues.
- Strong written skills for documenting changes, updates to risk files, and communication with leadership.
- Multidisciplinary assessment of complaints and problem-solving.
- Knowledge of CAPA processes and GDP.
- Familiarity with Excel for data analysis.
Day to Day Responsibilities:
- Complete product and manufacturing process changes, including documentation and risk file updates to ensure there is no adverse impact to the patient/user and product design integrity is maintained
- Implement change projects according to internal procedures, supervise progress, and communicate status to group leadership
- Communicate with Engineering, Manufacturing, Regulatory, and Quality colleagues
- Establish experimental protocols, conduct experiments, analyze results
- Support technical execution of Design History File (DHF) updates
- Establish and maintain relationships with Manufactuing site colleagues
- Support Manufacturing and Quality Assurance in the disposition of Non-Conforming Reports and the qualification of material/processes changes
- Establish and review specifications/requirements for components, products and processes
- Support CAPA investigations
- Ensures product conforms to current relevant international standards
- Support multi-functional assessment of complaint record
