Engineer III

Summary

Katalyst CRO is expanding its Combination and Medical Device Products Consumable Device US team. The Engineer III will focus on on-market change execution, product lifecycle management, and manufacturing support for medical devices, while also standardizing team activities for improved efficiency.

Responsibilities

• The Combination and Medical Device Products Consumable Device US team is expanding its support for on-market devices
• This role will be responsible for on-market change execution, product lifecycle management, and manufacturing support specific to the product design
• Proficiency with medical device/pharmaceutical DHF traceability is required
• Proficiency with test execution, deviation reporting and management, data review, and report writing is required
• Experience with medical device EU and/or FDA regulations is required
• In addition to product support, you will also be responsible for standardizing and simplifying activities within the team to enable more efficient development and marketed product support

Skills

• Proficiency with medical device/pharmaceutical DHF traceability is required
• Proficiency with test execution, deviation reporting and management, data review, and report writing is required
• Experience with medical device EU and/or FDA regulations is required
• Bachelor of Science degree with 3+ years of experience in medical device or pharmaceutical development roles
• Medical device/pharmaceutical development, office, and laboratory settings
• Design History File product lifecycle management experience
• On-market supplier changes
• Knowledge of applicable global regulatory requirements and industry standards (MDR requirements, ISO 13485, ISO 14971, ISO 10993, etc.)
• Exceptional written and verbal communication skills, and the ability to clearly articulate development challenges and implementation strategies to stakeholders across a broad range of functional groups at all levels of the organization, including external vendors
• Graduate degree in a technical or scientific field
• Prior experience in consumable medical device/pharmaceutical development
• Engineering degree in bioengineering, chemical engineering, or mechanical engineering

Qualifications

Must Haves

• Proficiency with medical device/pharmaceutical DHF traceability is required
• Proficiency with test execution, deviation reporting and management, data review, and report writing is required
• Experience with medical device EU and/or FDA regulations is required
• Bachelor of Science degree with 3+ years of experience in medical device or pharmaceutical development roles
• Medical device/pharmaceutical development, office, and laboratory settings
• Design History File product lifecycle management experience
• On-market supplier changes
• Knowledge of applicable global regulatory requirements and industry standards (MDR requirements, ISO 13485, ISO 14971, ISO 10993, etc.)
• Exceptional written and verbal communication skills, and the ability to clearly articulate development challenges and implementation strategies to stakeholders across a broad range of functional groups at all levels of the organization, including external vendors

Nice to Haves

• Graduate degree in a technical or scientific field
• Prior experience in consumable medical device/pharmaceutical development
• Engineering degree in bioengineering, chemical engineering, or mechanical engineering