Manufacturing Engineer

4 weeks ago

Mansfield, United States Intellectt Inc Full time

Role: Manufacturing Engineer III

Location: Mansfield, MA - 2048

Duration: 4 Months


Job Description:

M-F business hours

Would be looking for ME’s that have done IQ, OQ, PQ’s, strong Solidworks skills and knowledge of Medical Device regulations and cleanroom practices is desired.


ESSENTIAL DUTIES AND RESPONSIBILITIES

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

Primary responsibilities are to:

• Works within cross-functional project teams including Quality Assurance, Supplier Quality, Planning, Purchasing, Regulatory, and Manufacturing to maintain and improve manufacturing processes used to manufacture surgical products for the medical device industry.

• Designs, specifies, develops, and purchases manufacturing tooling, fixtures and equipment.

• Manages the implementation and validation of new or modified manufacturing processes and equipment to support the manufacture of lntegra products.

• Support and guide transfers internally within plant and externally with suppliers.

• Supports the selection and validation of replacement materials, such as polymers, metals, and adhesives used in the manufacturing of lntegra products.

• Writes and implements Manufacturing Procedures and Work Instructions.

• Creates, updates and maintains BOMs, Routers, and DMRs.


DESIRED MINIMUM QUALIFICATIONS

• Bachelor's degree in Mechanical, Manufacturing, Materials or Biomedical Engineering or equivalent is required.

• A minimum of 6 years of engineering industry experience is required.

• Experience in the medical device industry is required.

• Knowledge of GMPs, ISO 13485 Design Control, and Manufacturing Process IQ, OQ, PO qualifications as related to medical devices is required.

• Working knowledge in manufacturing processes such as metal processing (machining, polishing, welding), plastics processing, and mechanical assembly is required.

• Working knowledge of machine and tool design, equipment design, and the startup of new equipment is preferred.

• Experience working in a cleanroom environment is preferred.

• Six Sigma Statistical Process Analysis knowledge is required with certification preferred.

• Mentor and assist Blackbelts/Greenbelts on projects as needed. Assist with tools and Mintab software.

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