Katalyst Healthcare's & Life Sciences (Katalyst HLS) is a Global Contract Research Organisation that provides End-to-End Clinical Research Services for Healthcare and Life Sciences companies globally. At Katalyst HLS offers ICH-GCP compliant clinical trial services from Phase I–IV in all key therapeutic areas to support clinical development and research requirements and also provides validation, quality and regulatory services for Pharma/Bio-Pharma/Medical Device industries. 

Services:
- Clinical Trial Management
- Clinical Data Management
- Biostatistics & Statistical Programming
- Medical Writing
- Pharmacovigilance
- Quality and Regulatory Affairs
- GMP, GLP and GCP Validations
- Manufacturing Process Validations
- Equipments & Instruments Validations
- Computer Systems Validations
- Human Resourcing

Industry: Pharmaceutical Manufacturing
Company Size: 51-200 employees

Katalyst HealthCares & Life Sciences

Savvy Admin PROD

**Roles & Responsibilities**

-  Demonstrated experience working under Design Controls and ISO 13485 / FDA QSR environments.

-  Proven ability to conduct root cause analysis and support field driven corrective actions.

-  Strong written and verbal communication skills, including the ability to translate clinical feedback into engineering actions.

-  Ability to work independently, prioritize multiple issues, and lead crossfunctional technical efforts.

-  Direct exposure to field action support, complaints investigations, or post market surveillance.

-  Familiarity with human factors standards (IEC 62366), risk management (ISO 14971), and related FDA guidance.

-  Experience working closely with clinicians, clinical engineers, or medical affairs teams.

**Education & Experience**

-  Bachelor's degree in engineering or related technical field (mechanical, biomedical, or equivalent).

-  5 to 6 years of medical device development experience, including sustaining or post market engineering surveillance.

-  Experience with structural heart or transcatheter cardiovascular devices.

-  Experience owning or supporting IFUs, user needs, or human factors engineering for Class III medical devices.

R&D Engineer

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Katalyst HealthCares & Life Sciences

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