Katalyst Healthcares and Life Sciences
Responsibilities:
- Conduct experimental testing to support failure investigations and root cause analysis.
- Develop and execute test procedures to evaluate device performance and functionality.
- Analyze test data and apply statistical tools to derive actionable insights.
- Lead testing efforts for design changes and validate proposed modifications.
- Support scale-up, global launch, and continuous improvement of drug delivery devices.
- Collaborate with contract manufacturers and suppliers to ensure device quality and compliance.
- Maintain robust design history files for mechanical and electro-mechanical devices.
- Enhance Client's delivery device platform to meet evolving product and regulatory requirements.
- Plan and conduct work requiring independent evaluation and adaptation of techniques.
- Generate and maintain design specifications, protocols, and reports.
- Execute design verification/validation, FMEA, and statistical process controls.
- Perform system-level root cause investigations and coordinate design improvements.
- Ensure technical records are maintained in design history files.
- Collaborate with internal teams and external partners to develop manufacturing specifications.
- Stay current with regulatory standards, including 21CFR820 and ISO 14971.
- Strong experience in laboratory testing, particularly with combination products or medical devices.
- Proficiency in statistical analysis and experimental methods.
- Proven ability to solve problems, implement design solutions, and manage projects.
- Familiarity with regulatory requirements for medical devices.
- Exceptional attention to detail and organizational skills.