Job Description :
Job Title: Manufacturing Engineer (Medical Devices)
Location: Warsaw IN - 46580
Position Type: Contract-to-Hire
Relevant Experience (in Yrs): 2-4
Technical/Functional Skills
* Skilled and knowledgeable in manufacturing and product processing
* Knowledge and working application of Validation Principles and guidelines and medical devices industry practice.
* Must have prior experience with IQ/OQ/PQ - equipment validation and process validation experience needed.
* Strong understanding of statistical analysis tools and methods knowledge and experience in cGMP CAPS, root cause analysis, risk assessment and investigation tools and techniques
* Experienced in GMP and 21 CFR Part 11
* Knowledge and working application of FMEA and Risk Analysis.
* Ability to effectively work within a team to expedite completion of critical project tasks with other functional groups
* Ability to handle project assignments of medium scope and complexity and ability to prioritize and complete work in a timely manner
* Demonstrates good problem solving skills through the use of quality and statistical tools
* Ability to effectively work within a team and cross-functionally to expedite completion of critical project tasks
Roles & Responsibilities
* Provide validation support by applying manufacturing quality toolset including but not limited to: FTA, FMEA, DFEMEA, PFMEA, IQ, OQ, PQ, analysis, control plans, verification/validation plans, validation protocol development, Cpk, Cp, SPC, DOE, process data analysis, and DMAIC.
* Develop and execute IQ, OQ and PQ protocols for product, processes and equipment.
* Review existing validation reports and identifies gaps for GMP compliance.
* Write reports summarizing results and statistics for all equipment, product, or process validation projects.
* Participate as an active member on new product development teams.
* Monitor and drive corrective action and continuous improvement activities that directly impact performance measures.
* Provide day-to-day support to development, engineering and manufacturing for design control planning and design transfer activities.
Education: Bachelor’s degree in science or mechanical engineering