Manufacturing Engineer

Job Title: Manufacturing Engineer

Location: Jacksonville, FL
Duration: 12+Months (Possibility of extension)

JOB ROLE & RESPONSIBILTIES:

· This position has the responsibility and authority to support the Manufacturing Engineering group: Develops, refines, maintains and relocate new and existing manufacturing processes, including the creation of manufacturing processing documentation, equipment operating instructions, and product routers.

· Designs, constructs and maintains assembly fixtures and test equipment.

· Generates, collects and analyses process data, prepares specifications, and evaluates materials and components.

· Qualifies and/or validates manufacturing processes and trains production operators.

MAIN JOB DUTIES/RESPONSIBILITIES – ESSENTIAL

· Designs, develops, and controls projects associated with the development of new, current, or acquired manufacturing processes.

· Participates in new product project team activity, supporting design for manufacturing elements.

· Generates, collects and analyses data and prepares specifications, and orders materials and components.

· Working understanding of Process Verification and Validation, including Validation Master Planning, Installation Qualification, Operational Qualification, and Performance Qualification.

· Provide engineering support for complex medical devices during their development, product launch, and product lifecycle management

· Provide technical oversight for manufacturing production performance, including product yield and cycle time management, and driving continuous improvements

· Ability to understand product requirements and establish risk-based production controls through data-driven capability analysis, manufacturing control plans, and product acceptance activities

· Works with new process development engineering in the evaluation of new processes

· Drives a Quality focused culture by monitoring compliance to Quality System processes, such as system transaction compliance, documentation practices, non-conforming material, product holds, Line Clearance, etc.

· Designs, constructs, and maintains assembly fixtures and equipment supporting a Lean manufacturing environment.

· Ability to understand product requirements and establish risk-based production controls through data-driven capability analysis, manufacturing control plans, and product acceptance activities

· Plans and performs a wide variety of technical tasks to develop robust processes and solve non-routine complex manufacturing problems in an effort to maximize consistency, cost effectiveness, and productivity.

· Assist in project planning and budgeting.

· Collaborates in the design of all special production machinery (jigs, tools, fixtures, machines, and handling equipment) to maintain manufacturing operations at competitive levels

· Reviews process yields and tracts defects with the Quality Department against cost of quality

· Partners with other departments to ensure that the manufacture and purchase of components meet functional requirements at the lowest possible costs

· Limited travel will be required.

· Complies with the Healthcare Site Quality System.

· Performs duties in compliance with environmental, health and safety related site rules, policies or governmental regulations.

· Required to interact and communicate with peers and co-workers.

· Required to spend extended periods of time on computer-based work.

· Performs other duties as assigned.

BASIC QUALIFICATIONS –
Education

· Bachelor of Science in Electrical Engineering, Mechanical Engineering or similar relevant discipline required.

· Master of Science in Electrical Engineering, Mechanical Engineering or similar relevant discipline preferred

Years of Experience

· Minimum of 4 years of experience in a medical device (aerospace or equivalent) manufacturing environment

Skills and Qualifications

· Experience in medical product manufacturing/assembly operations is a plus

· Demonstrated Project Planning and execution experience on major projects

· Green Belt Certification

· 2 years of Lean Sigma Project Execution experience.

· Demonstrated Project Planning and execution experience on major projects.

· Kaizen facilitation experience

· Strong interpersonal Skills

· Experience comprehending quality system process documents

· Experience interpreting mechanical drawings

· Experience understanding proper documentation/quality requirements for a regulated environment is a plus

· Aptitude for quickly learning and as simulating a broad array of information

· Excellent data analysis skills, and proficient in the use of statistical tools in problem solving

· Understanding of development validation

We do have referral bonus of $500 per candidate, if you refer any of your friends or colleague who are looking out for the same job.

Thanks & Regards,

Seema Chawhan
Clinical Recruiter
Integrated Resources, Inc.
IT Life Sciences Allied Healthcare CRO
Certified MBE |GSA - Schedule 66 I GSA - Schedule 621I
DIRECT # - 732-844-8724

LinkedIn: 

https://in.linkedin.com/in/seemachawhan

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