VALIDATION ENGINEER II

Millstone Medical•Olive Branch, MS

3d•Onsite

About The Position

Millstone Medical Outsourcing is looking for an energetic individual to join its Engineering Department as Validation Engineer II. Millstone is a fast growing, fast paced medical service provider for the top Orthopedic companies in the industry. Millstone’s business focus is sterile and non-sterile packaging of medical devices. Millstone also engages in other activities, such as mechanical inspection and assembly, which are designed to meet the outsourcing requirements of medical device manufacturers seeking to reduce costs while maintaining high levels of quality, accuracy and timeliness. We are FDA and ISO registered and employ a detailed internal quality system to ensure ISO compliance.

Requirements

Knowledge of cleaning, sealing, and sterilization processes and the corresponding regulatory requirements
Ability to independently use production equipment.
Adept in use of Metrology tools including calipers, micrometers and other test equipment
Ability to troubleshoot equipment.
Ability to read and interpret schematics and detailed mechanical drawings.
Ability to multitask.
Detail Oriented
Math skills
Basic math through Calculus
Basic skills in Statistics
Ability to record and interpret test data, compile reports.
Advanced – Ability to create spreadsheets and other documents.
GMPs (Good Manufacturing Practices)
Knowledge of cGMP requirements
Ability to interact with all levels of the facility.
Ability to interact with clients and interpret their needs with little to no coaching.
Ability to work and interact in a team environment.
Ability to effectively communicate issues and solutions verbally and in writing.
Get the job done attitude.
Able to meet or exceed established commitments.
Willingness to do what needs to be done to meet customer needs/timelines.
Ability to change gears easily as priorities shift.
Bachelor’s degree in engineering
2-3 years engineering experience
Understanding of Minitab

Responsibilities

Responsible for the program launch process, including establishing and validating processes (related to critical cleaning and sterile packaging of orthopedic medical devices and pharmaceutical products) based on Millstone, customer, and regulatory requirements while ensuring the process can be sustained by Millstone’s operations team.
Working with the Manager or Director to adhere to all manufacturing financial commitments in the new program business case including product cost estimates and manufacturing process CAPEX & OPEX budgets.
Collaborating with AME, ME, Quality, and Operations to ensure process designs are cost effective and robust.
Ability to train production operators during process qualifications.
Able to guide others in the use of test equipment/tooling/processes.
Ability to determine/recommend operating parameters for production equipment.
Ability to conceptualize new tools as required.
Ability to perform detailed engineering work with support from senior engineers or management.
Escort vendors within facility and provide technical knowledge as needed.