Engineer II, Advanced Surgery

Overview

Support the Sustaining Engineering team in maintaining and improving existing products, processes, and systems, with a focus on change management activities within the Site/Product Operations or Single Point Ownership (SPO) team.

What you'll do

• Coordinate and track engineering changes, product updates, and process modifications through established quality and regulatory procedures.
• Initiate, plan and complete small or complex projects by monitoring, tracking and analyzing project activities and metrics.
• Serve as SPOC for the team and collaborate with project stakeholders.
• Handle change controls and change management activities.
• Ensure implementation of quality processes including change control and design control activities.
• Prepare and review project-related documents, protocols and reports as required.
• Assist the Project Manager in reviews and ensure the project complies with QA processes and defined timelines.
• Review changes to existing processes and products, drive them via change control, and ensure timely completion and closure.
• Work with the global team and coordinate with stakeholders (PDO, QA, RA, etc.) to understand requirements, prioritize tasks and ensure completion.
• Participate in and lead cross-functional meetings to communicate priorities, requirements, key issues and risks, and set clear expectations.
• Independently drive change controls, resolve queries and concerns as needed, and drive projects to completion.

What you'll need

• Bachelor's or Master's degree in Bio Medical or Mechanical Engineering, or equivalent, with 3+ years of experience in Sustaining Engineering projects.
• Excellent verbal and written skills in English.
• Excellent communication and presentation skills.
• Ability to communicate effectively in a multi-cultural working environment.
• Strong collaboration and interpersonal skills.
• Ability to coordinate with stakeholders of cross-functional and Leadership Teams.
• Excellent critical thinking and problem-solving skills and application of methods and tools.
• Independent worker as well as team player with strong execution abilities to complete projects within timeline.
• Knowledge of (U.S.) and EU regulations and medical device standards: ISO 13485, ISO 14971.

Nice to have

• Experience in Change Management processes and tools.