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Manufacturing Engineer

3 months ago

Fall River, Massachusetts, United States Millstone Medical Full time

***Local Candidates Only***

Come join Millstone Medical and become part of our dynamic organization

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

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 voluntary benefits in addition to an employee-centric work environment.

Who are we? Millstone is a fast growing, fast paced medical service provider for the top Orthopedic companies in the industry. Millstones 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.

***Medical Device Experience preferred

*** Local candidates ONLY***

***VISA SPONSORSHIP IS NOT AVAILABLE FOR THIS POSITION ***

MANUFACTURING ENGINEER

JOB SUMMARY:

Millstone is seeking an energetic and engaged Manufacturing Engineer to identify and drive continuous improvement. As our Manufacturing Engineer, you will be responsible for developing and implementing mistake-proof processes, equipment, and tooling used to execute on critical cleaning and sterile packaging of orthopedic medical devices.

Manufacturing Engineering (ME) is responsible for equipment selection, installation, validation, maintenance and calibration, improvements, documentation, spare parts, and of course Product Quality. As a Manufacturing Engineer, you will be in a position to ensure our legacy product lines are continuously improved and new product lines transition smoothly into full production, all while adhering to financial and scheduled commitments.

RESPONSIBILITIES:

Provide technical leadership and guidance for product quality, process compliance with all applicable regulations, Millstone quality system requirements, applicable safety standards, and policies

Oversee development and implementation of timely, economical, repeatable, validated, mistake-proof manufacturing processes and controls for new and legacy products

Drive continuous improvement and lean manufacturing methodologies into production

Responsible for timely equipment troubleshooting and repair, development of systems and procedures to be used for product quality and process capability improvements

Trend preventive maintenance and calibration data for end-of-service predictions using predictive analytics

Collaborate and partner with various departments to investigate and troubleshoot process or equipment issues, and to implement specific corrective actions using PFMEA, root cause analysis, and other risk management methodologies

Act as an integral member of project teams tasked with resolving technical issues or continuous improvement projects

Collaborate with program development on new product launches and product transfers to manufacturing. Develop and conduct Factory Acceptance Tests and equipment validation ensuring a high degree of process capability.

Responsible for all necessary documentation and approvals; standard operating procedures, work instructions, and assist with related training

Develop workable project plans and timelines to meet goals

Develop workplan and measurement data templates within the regulatory asset manager

All other duties as assigned

KNOWLEDGE & SKILLS:

B.S. Degree in Engineering with 2-5 years of experience in medical device processing/manufacturing engineering/product development.

Ability to work in a fast-paced environment with multiple priorities

Exemplary verbal and written communication and organizational skills

Ability to work with a team or independently with minimum supervision

OEE, GMP Practices, lean certified, black belt in six sigma and Minitab proficiency is highly preferred

Knowledge of, or experience with, automated systems or UV glue system is a plus

ADDITIONAL INFORMATION:

To learn more about Millstone Medical Outsourcing and all its current employment opportunities, please visit us at

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.