Job Description

VALIDATION ENGINEER II

We Deserve the Best – And So Do You!

High Growth Company

Opportunity to Learn and Grow

Shape your Career

See the Importance of Your Work

Come join Millstone Medical and become part of our dynamic organization! 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.

The Validation Engineer II is responsible for the program launch process. This includes 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. The VE is also responsible for 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. The VE will collaborate with AME, ME, Quality, and Operations to ensure process designs are cost effective and robust.

Job Specific Competencies

Mechanical Aptitude

• Knowledge of cleaning, sealing, and sterilization processes and the corresponding regulatory requirements
• Ability to independently use production equipment.
• Ability to train production operators during process qualifications.
• Adept in use of Metrology tools including calipers, micrometers and other test equipment
• Able to guide others in the use of test equipment/tooling/processes.
• Ability to troubleshoot equipment.
• Ability to determine/recommend operating parameters for production equipment Ability to conceptualize new tools as required.
• Ability to read and interpret schematics and detailed mechanical drawings.

Organizational skills

• Ability to multitask.
• Detail Oriented
• Math skills
• Basic math through Calculus
• Basic skills in Statistics
• Ability to record and interpret test data, compile reports.

Software & Computer skills

• Advanced – Ability to create spreadsheets and other documents.
• GMPs (Good Manufacturing Practices)
• Knowledge of cGMP requirements
• Interpersonal skills
• Ability to interact with all levels of the facility.
• Ability to interact with clients and interpret their needs with little to no coaching.
• Escort vendors within facility and provide technical knowledge as needed.
• Ability to work and interact in a team environment.
• Ability to perform detailed engineering work with support from senior engineers or management.
• Ability to effectively communicate issues and solutions verbally and in writing.

Work Ethic

• 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.

Minimum Qualifications

• Bachelor’s degree in engineering
• Practical Experience 2-3 years engineering experience
• Understanding of Minitab

Physical Demands

• Standing
• Stooping
• Light Lifting (occasional lifting of 25 lbs. or less)
• Heavy Lifting (frequent lifting of 25 lbs. or more)
• Manual Dexterity, small tool use, soldering
• Ability to read fine print, on paper and computer screen.
• Vision – 20/20 or corrected 20/20 vision is required.
• Climb Ladders
• Travel as needed

ADDITIONAL INFORMATION:

Millstone Medical Outsourcing offers a competitive salary, health, dental and vision benefits beginning on the first day of employment and 401K with company match. Other benefits include paid vacation, paid sick time, holiday pay, tuition reimbursement and many other voluntary benefits in addition to an employee-centric work environment. To learn more about Millstone Medical Outsourcing’s opportunities, please visit us online at www.millstonemedical.com

Millstone Medical Outsourcing provides equal employment opportunity to all applicants and employees. No person is to be discriminated against in any aspect of the employment relationship due to race, religion, color, sex, age, national origin, ancestry, disability, sexual orientation, gender identity, genetic information, citizenship status, marital status, pregnancy, veteran status or any other status protected by applicable federal, state, or local law.

All employment offers are contingent upon successful completion of our pre-employment drug screening and background/criminal check, consistent with applicable laws.