Senior Medical Device Engineer: Lifecycle & Compliance

Embecta Corp.; Dún Laoghaire; Hybrid; EUR 70,000 - 100,000; Full time

Job summary

embecta, Dun Laoghaire (Hybrid), seeks a Senior Product Engineer to bolster the product lifecycle engineering team on a global basis. You will work with product development, regulatory affairs, marketing, operations and manufacturing to support current diabetes-related products and line extensions.

The role requires a Bachelor's in Engineering, 5+ years in medical device design or R&D, plus experience in design verification, polymers and injection molding, and project management within change

Qualifications

• Bachelor's degree in Engineering or Science as a baseline requirement.
• PM qualification is an advantage for project leadership.
• 5+ years in medical device design or R&D with market delivery.
• Experience with medical product design, development and launch.
• Exposure to high volume manufacturing and polymer processing.

Responsibilities

• Plan and execute product lifecycle projects impacting form/fit/function and cost.
• Lead projects through change control and regulatory processes.
• Communicate updates to management and cross-functional teams.
• Ensure compliance with quality and safety regulations.
• Collaborate with manufacturing to resolve issues and improve products.
• Maintain design history files and perform device compatibility testing.
• Design test equipment and validated procedures for ISO compliance.

Skills

Project Management

GD&T

3D CAD modeling

Statistical analysis

Test method validation

Education

Bachelor's degree in Engineering

Job description

embecta, Dun Laoghaire (Hybrid), seeks a Senior Product Engineer to bolster the product lifecycle engineering team on a global basis. You will work with product development, regulatory affairs, marketing, operations and manufacturing to support current diabetes-related products and line extensions.

The role requires a Bachelor's in Engineering, 5+ years in medical device design or R&D, plus experience in design verification, polymers and injection molding, and project management within change