Job OverviewThe primary responsibility for this Engineer I, Production position will be reviewing production documentation and addressing deficiencies found, performing equipment qualifications, and other improvements related to compliance issues. Lead and execute process validation requirements in parallel with identifying and implementing improvement and cost elimination projects for manufacturing. This position will report to the Supervisor, Manufacturing Engineering.
Job Responsibilities and Essential Duties- Initiate Design Changes and Change Notices to document changes being implemented.
- Write and execute validation protocols, to demonstrate acceptability of a proposed change. Compile and analyze protocol test data.
- Review procedures and determine whether they are being followed. Implement changes as needed. (Engineering specifications, change notices, manufacturing procedures, equipment registrations and other documentation).
- Comply with Quality System Procedures, Good Lab Practices, and Exposure Control Plan.
- Support efforts for complaint investigation compliance with the Food and Drug Administration (FDA), European Union Medical Device Regulation (MDR) and European Union Medical Device Reporting (EUMDR), Alternate Summary Report (ASR), and applicable regulations and regulatory governing standards.
- Assess and Implement solutions relating to corrective and preventative actions, calibration out of tolerances, non-conformances.
- This is not an inclusive list of job responsibilities.
Minimum Requirements- Bachelor of Science degree, preferably in Biomedical, Mechanical, Manufacturing Engineering or equivalent with 0-2 years of related experience.
- General understanding of Good Manufacturing Practices, FDA regulations, and ISO requirements.
- Experience working in a regulated environment preferred
- Experience with Windchill software a plus
- Formal training and/or experience in process validations/qualifications and statistics a plus.
Required Knowledge, Skills, and Abilities- Strong technical and analytical ability, ingenuity. Detail oriented.
- Must be a good communicator, both verbal and written communication skills, with good interpersonal skills.
- Good organizational skills. Must be able to adhere to timelines.
- Computer skills including, but not limited to: Microsoft Windows, Word, Excel.
- Familiarity with statistical analysis.
- Project Management.
This role is a hybrid position based in Wayne, NJ with a few days a week required in office.
Pay rate: $88,000 - $92,000 / year + 8% annual bonus
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