Process Engineer

Millstone Medical; Olive Branch, Northern (MS, KY); On-site; USD 65,000 - 90,000; Full time

Job summary

Millstone Medical Outsourcing is a fast-growing provider specializing in sterile/non-sterile packaging and related services. The Process Engineer will develop and document manufacturing processes, validate equipment, and support improvements while ensuring high quality and efficiency.

The role requires a Bachelor’s Degree in engineering and strong documentation skills. You will work with manufacturing teams to train operators, estimate staffing and costs, and coordinate with machine shops and

Qualifications

• Bachelor’s Degree in engineering required.
• Experience with process validations and documentation.
• Ability to write and edit validation procedures and drawings.
• Strong organizational and data interpretation skills.

Responsibilities

• Document and execute process validations on manufacturing equipment.
• Estimate staffing, production times, and costs for decisions.
• Develop and implement training for production staff.
• Design and improve manufacturing processes for cost reductions.
• Create and maintain tool drawings, shop orders, and QA docs.
• Provide engineering support to resolve technical issues.
• Coordinate work with machine shops and vendors.
• Oversee facility improvements and changes.

Skills

Train production operators

Test equipment usage

Mechanically inclined

Operating parameters

Technical writing

Validation procedures

Procedures accuracy

Organization

Data recording & reporting

MS Office suite

AutoCAD

GMP knowledge

Cross-functional collaboration

Education

Bachelor’s Degree in Engineering

Tools

AutoCAD

Microsoft Excel

Microsoft PowerPoint

Microsoft Word

Job description

Come join Millstone Medical and become part of a high growth company where you will have the opportunity to learn and grow in an employee-centric culture and see the importance of your work!

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.

What's in it for you?

A company committed to quality, growth, career pathing.

At Millstone, we want you to be your best at work and at home. In addition to competitive compensation, we have designed our Total Rewards Benefits Program to support the physical and emotional well-being of our employees and their families.

• Medical - Starting on the 1st day of employment


• Dental - Starting on the 1st day of employment


• Vision - Starting on the 1st day of employment


• Supplemental Benefits - Life, Disability, Critical Illness


• Paid Time Off


• Tuition Reimbursement


• Career Pathing

The Process Engineer will develop, evaluate, improve, and document manufacturing processes.

Responsibilities:

• Document and execute process validations on various types of manufacturing equipment.


• Estimating staffing requirements, production times, and relative costs to provide data for operational decisions.


• Works closely with manufacturing department to development, coordinate, and implement technical training for employees.


• Designs and develops manufacturing processes for enhancements, product changes, and new products and related fixtures and tooling that are consistent with zero defect level and low product cost.


• Creates and maintains accurate documentation of tool drawings, design concepts, shop orders, and concepts in accordance with the R&D and quality assurance functions.


• Provides engineering support in production department to trouble shoot and resolve technical problems.


• Coordinates work with machine shops, assigned technicians, and outside vendors.


• Managing, evaluating, and implementing of facility improvements and changes.

Knowledge & Skills:

• Ability to train production operators during process qualifications


• Adept in use of calipers, micrometers, and other test equipment and able to guide others in the use of test equipment/tooling


• Mechanically inclined in the installation, set up and operation of production equipment


• Ability to grasp modern technology quickly and establish operating parameters for production equipment


• Must have technical writing skills for validations/procedures and the ability to create/edit component/packaging drawings


• Ability to write Client Specific Validation and procedures accurately


• Ability to review and correct procedures/prints for accuracy


• Great organizational skills with the ability to multitask


• Ability to record and interpret test data, compile reports


• Advanced ability to create Microsoft Excel, PowerPoint & Word documents


• Mid-level – Familiar with Microsoft Office (Word, Excel, Powerpoint)


• Advanced – Ability to create spreadsheets and other documents


• AutoCad/GMPs (Good Manufacturing Practices)/Knowledge of GMPs; and the ability to guide others to maintain GMP compliance


• Ability to interact with all levels of the facility; and with clients and interpret their needs


• Escort clients within facility and provide technical expertise as needed


• Ability to work and interact in a team environment


• Ability to work assigned tasks unsupervised with a get the job done attitude


• Able to meet or exceed established timelines with reliable attendance


• Willingness to exceed required hours to meet customer needs/timelines


• Ability to change gears easily with priority changes


• Bachelor’s Degree required with prior engineering experience

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.

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#OBSLRY

Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws.For further information, please review the Know Your Rights notice from the Department of Labor.