Engineer II, Product Sustaining

Getinge•Wayne, NJ

55d•$94,000 - $97,000

About The Position

The primary responsibility for the Sustaining Engineer II position focuses on Design Verification and Validation activities, supporting testing for regulatory submissions, CAPA execution, writing and executing Test Method Validations, and working with component suppliers. This position will report to the Sustaining Engineering Manager.

Requirements

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.
Experienced with laboratory physical testing methods Validation/Verification
Process Validation/Verification
Knowledge with the following systems: CAPA, Risk Management, Design Controls and Change Management
Must have strong technical and analytical ability; detail oriented.
Must have good verbal and written communication skills.
Strong interpersonal skills.
Good organizational skills. Must be able 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.

Responsibilities

Write and execute protocols, such as Design Validations or Verifications. Compile, analyze and report protocol test data.
Write and execute Test Method Validations. Compile, analyze and report testing data.
Update Design Specifications, Risk Management Plans and Reports, FMEAs, or other risk management documents.
Investigate and plan 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, and other documentation).
Comply with Quality System Procedures, Good Lab Practices, and Exposure Control Plan.
Develop processes, methods, tooling, and production controls; supervises their assembly and proofing.
Prepares presentations reflecting the status and results of projects.
Lead small projects that support product enhancement and cost savings opportunities.
This is not an inclusive list of job responsibilities.