Getinge is searching for an Engineer II to join our Sustaining Engineering team. In this role, you will focus on Design Verification and Validation activities, supporting critical testing for regulatory submissions and ensuring product quality. You will report directly to the Sustaining Engineering Manager and contribute to our mission of making life-saving technology accessible.

What You'll Do

Write and execute protocols such as Design Validations or Verifications; compile, analyze, and report test data.
Write and execute Test Method Validations; compile, analyze, and report testing data.
Update Design Specifications, Risk Management Plans and Reports, FMEAs, and other risk management documents.
Investigate and plan Corrective and Preventive Action (CAPA) activities.
Communicate and coordinate activities with other Getinge sites and outside component suppliers.
Implement documentation changes as needed (Engineering specifications, change notices, manufacturing procedures).
Comply with Quality System Procedures, Good Lab Practices, and Exposure Control Plan.
Develop processes, methods, tooling, and production controls; supervise their assembly and proofing.
Prepare presentations reflecting the status and results of projects.
Lead small projects that support product enhancement and cost savings opportunities.

What We're Looking For

Bachelor of Science degree (or equivalent), preferably in Biomedical, Mechanical, or Manufacturing Engineering with 3-6 years of related experience.
General understanding of Good Manufacturing Practices, FDA regulations, and ISO requirements.
Experience with process and equipment validations/qualifications.
Experience with laboratory physical testing methods Validation/Verification.
Experience with Process Validation/Verification.
Knowledge of the following systems: CAPA, Risk Management, Design Controls and Change Management.
Strong technical and analytical ability; detail oriented.
Good verbal and written communication skills.
Strong interpersonal skills.
Good organizational skills; ability to adhere to timelines.
Knowledge of computer skills including, but not limited to: Microsoft Windows, Word, Excel, Project, PowerPoint, Teams, Solidworks.
Basic understanding of statistical analysis.