Sr. Engineer, Production

Getinge•Wayne, NJ

About The Position

With a passion for life, join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers. Are you looking for an inspiring career? You just found it.

Requirements

Bachelor of Science degree in Mechanical, Manufacturing or Biomedical Engineering with 5 years of experience in manufacturing and engineering.
Strong technical and analytical ability.
Effective verbal and written communication skills and interpersonal skills. Team player.
Experience with project management, process development & process validations.
Demonstrated ingenuity and creativity.
Proficiency with Microsoft Office applications.
Working knowledge of statistical analysis., and DOE (Design of Experiments).
General knowledge of Lean Manufacturing and Six Sigma principles.
General understanding of GMPs (Good Manufacturing Practices) and FDA regulations

Responsibilities

Lead projects in the areas of process and product improvements, including cost reduction projects
Investigation and response to production issues or to customer complaints
Mentor lower-level engineers
Ensure compliance to regulations of FDA, and other regulatory bodies
Assist in the transfer of new products from NPD (New Product Development) to Manufacturing.
Develop and maintain production documentation such as procedures, routers, BOMs.
Responsible for the development/refinement of production processes and equipment; development and execution of process validations (Installation, Operational, & Process Qualifications) with sound engineering practices, and within company policy and regulations of FDA, and other regulatory bodies.
Provides training and guidance to lower-level Manufacturing Engineering personnel. Guidance may be technical, or project related as Project Leader or Lead Engineer of small to medium projects
Support efforts for complaint investigation compliance with the Food and Drug Administration (FDA), European Union Medical Device Directive (MDD), European Union Medical Device Reporting (EUMDR), Alternate Summary Report (ASR), and applicable regulations and regulatory governing standards.
Ensure timely and accurate investigations of returned products to support effective complaint closures as required by Complaint Engineering group.
Supports the FDA and other 3rd party audits as required by Complaint Engineering group.
Lead and execute design changes applicable to Manufacturing Engineering needs
Assess and Implement solutions relating to Corrective and Preventative Actions, Calibration Out of Tolerance Calibrations, Non-conformances.