Sr. Engineer, Production - Wayne, NJ

Job Overview

The primary responsibilities of the Senior Production Engineer position are:

• 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.

 

Job Responsibilities and Essential Duties

• 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.  The Senior Engineer utilizes a wide range of engineering principles, theories and concepts in the manufacturing/mechanical engineering discipline, plus a working knowledge of related disciplines to solve a wide range of difficult problems with imaginative and practical approaches.     
• 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.

 

Minimum Requirements

• Bachelor of Science degree in Mechanical, Manufacturing or Biomedical Engineering with 5 years of experience in manufacturing and engineering. 

 

Required Knowledge, Skills and Abilities

• 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.

 

#LI-AS1

Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.

 

Salary range:  $95 - $125k