Job Title: Sr. R&D Sustaining Engineer (Medical Devices)
Pay Rate: $55 to $70/Hr
Duration: 12 Months
Location: Austin, TX
Shift - 8 AM to 5 PM Central time
This position is for the Healthcare Diagnostics division.
We are looking for a Sr. R&D Sustaining Engineer in theplatform sustaining engineering groupto support a new product that was recently launched.
- Product Support & Troubleshooting
- Investigate and resolve technical issues related to design, materials, or performance.
- Analyze field data and customer feedback to identify trends or recurring problems.
- Design Changes & Improvements
- Lead and implement engineering changes (ECR/ECO process) to enhance product quality, cost-efficiency, manufacturability, or compliance.
- Support cost-reduction and product optimization initiatives without compromising safety or performance.
- Regulatory & Quality Compliance
- Ensure any product modifications meet FDA, ISO 13485, and other relevant regulatory standards.
- Collaborate on risk management activities (e.g., FMEA updates) and document changes appropriately.
- Cross-Functional Collaboration
- Work with manufacturing, quality, regulatory, and supply chain teams to ensure smooth implementation of changes.
- Support audits and inspections by providing technical documentation and product history.
- Documentation & Validation
- Update design history files (DHF), technical files, and other product-related documentation.
- Plan and execute validation and verification (V&V) testing for changes in design or processes.
- Supplier & Component Management
- Evaluate and qualify new suppliers or components due to obsolescence, performance issues, or cost-saving efforts.
- Conduct root cause analysis and corrective actions for supplier-related problems.
Requirements:
- Degree in Mechanical Engineering, Biomedical Engineering, or Manufacturing Engineering.
- 6 years of experience with a BS degree or 4 years of experience with a master’s degree
- Experience in design changes and maintenance releases in medical device products.
- Hands-on mechanical design experience, including building and prototype testing.
- Ability to create drawings and assemblies within SolidWorks or other drafting applications.
- Supporting the maintenance and changes to design history files.
- Experience with root cause analysis in medical device products.
Nice to have:
- Working with outside vendors.
- Data analysis, statistical analysis, and technical reporting.
- Defining anddeveloping test procedures for verification and validation.
- Handling field complaints.
- Assessing the production impact of design changes and collaborating with purchasing and production teams.
