Engineer III

Engineer III

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 product design.

Top Skills:

• Design History File (DHF) product lifecycle management experience
• Engineering degree in bioengineering, chemical engineering, or mechanical engineering
• On-market supplier changes
• Knowledge of applicable global regulatory requirements and industry standards, including MDR requirements, ISO 13485, ISO 14971, and ISO 10993
• Exceptional written and verbal communication skills, with the ability to clearly articulate development challenges and implementation strategies to stakeholders across functional groups and external vendors

Skills:

• Proficiency with medical device/pharmaceutical DHF traceability required.
• Proficiency with test execution, deviation reporting and management, data review, and report writing is required.
• Experience with medical device EU and/or FDA.
• Responsible for standardizing and simplifying activities within the team to enable more efficient development and marketed product support.

Requirements:

- Bachelor of Science degree with 3+ years of experience in medical device or pharmaceutical development roles.

Desired:

• Graduate degree in a technical or scientific field.
• Prior experience in consumable medical device/pharmaceutical development.

Environment:

- Medical device/pharmaceutical development, office and laboratory settings.

Schedule:

• Eight hours a day, forty hours a week.
• Occasional overtime required based on the need and urgency of project deliverables.

Onsite:

- Hybrid onsite schedule is possible. Based on the needs of the work, there might be weeks where onsite is needed for the full week. There might be one day in two weeks that the candidate may be able to work from home to complete documentation based on project deliverables.