Engineer I, Production

Getinge•Wayne, NJ

11d•$88,000 - $92,000•Hybrid

About The Position

The Engineer I, Production reviews production documentation and addresses deficiencies, performs equipment qualifications, and makes improvements related to compliance issues. The role leads and executes process validation requirements while identifying and implementing manufacturing improvements and cost-elimination projects. It reports to the Supervisor, Manufacturing Engineering. This is a hybrid position based in Wayne, New Jersey, requiring a few days in the office each week. The listed pay rate is $88,000–$92,000 per year, plus an 8% annual bonus.

Requirements

Bachelor of Science degree, preferably in Biomedical, Mechanical, or Manufacturing Engineering, or equivalent, with 0–2 years of related experience.
General understanding of Good Manufacturing Practices, FDA regulations, and ISO requirements.
Strong technical and analytical ability, ingenuity, and attention to detail.
Strong verbal and written communication and interpersonal skills.
Good organizational skills and ability to adhere to timelines.
Computer skills, including Microsoft Windows, Word, and Excel.
Familiarity with statistical analysis.
Project management skills.

Nice To Haves

Experience working in a regulated environment.
Experience with Windchill software.
Formal training and/or experience in process validations or qualifications and statistics.

Responsibilities

Initiate Design Changes and Change Notices to document changes being implemented.
Write and execute validation protocols to demonstrate the acceptability of a proposed change; compile and analyze protocol test data.
Review procedures to determine whether they are being followed and implement changes as needed, including to engineering specifications, change notices, manufacturing procedures, equipment registrations, and other documentation.
Comply with Quality System Procedures, Good Lab Practices, and the Exposure Control Plan.
Support complaint investigation compliance with FDA, European Union Medical Device Regulation (MDR), European Union Medical Device Reporting (EUMDR), Alternate Summary Report (ASR), and applicable regulations and regulatory governing standards.
Assess and implement solutions related to corrective and preventative actions, calibration out of tolerances, and non-conformances.
Identify and implement manufacturing improvement and cost-elimination projects.