Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
Company : Katalyst Healthcares & Life Sciences
Responsibilities:
- Execute Design Verification/Validation Strategies with emphasis on.
- Technical analysis of requirements, specifications, and control strategy.
- Alignment of design outputs to production and process controls.
- Proper verification techniques including inspection, demonstration, test, etc.
- Lead design characterization activities for development projects.
- Support design test and inspection method development and lead method validation activities.
Requirements:
- Bachelor level degree in Engineering or Technical Field; advanced degree / Biomedical Engineering / Electrical Engineering / Computer Science preferred.
- 3-5+ years Engineering experience with new product development.
- Experience in supplier controls, critical quality attributes, and tracing design outputs to implemented supplier processes.
- Working knowledge on design verification and design validation techniques.
- Working knowledge of applied statistics, sampling strategies, and design of experiments, including statistical software tools such as Minitab.
- Strong organizational and follow-up skills, as well as attention to detail.
- Ability to collaborate on-site on a regular basis.
- Knowledge of FDA, IEC 60601, GMP, ISO 13485, and ISO 14971.
- Prior medical device experience preferred.