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Manufacturing Engineer

2 months ago

Fall River, Massachusetts, United States Millstone Medical Full time

Job Summary:

Millstone Medical is seeking a highly skilled Manufacturing Engineer to join our team. As a 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.

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.

Requirements:

  • 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.

About Millstone Medical:

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.