R&D Engineer

Katalyst CRO; Houston (TX); On-site; USD 110,000 - 170,000; Full time

Job summary

Katalyst CRO is seeking a skilled medical device development engineer to join our team in Houston, TX. The role focuses on design controls, post-market surveillance, and collaboration with clinicians and medical affairs to translate feedback into engineering actions.

The ideal candidate has 5–6 years of experience in medical device development, including Class III devices, and a track record in IFUs and human factors engineering within ISO 13485/FDA QSR environments.

Qualifications

• 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.

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.

Skills

Design Controls

ISO 13485

FDA QSR

Root cause analysis

Communication

Independent worker

Crossfunctional teamwork

Field action support

Human factors IEC 62366

ISO 14971

Clinical collaboration

Education

Bachelor's degree in engineering or related technical field

Job description

• 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.

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.

Requirements

• 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.