Manufacturing Engineer II Job Chicopee area,Massachusetts USA,Engineering

Compensation

Target PR Range: 40-50/hr DOE

Duties

What Manufacturing Engineering contributes to:
Manufacturing Engineering is responsible for developing manufacturing processes, production floor layouts and associated tools. Reviews new designs for manufacturability. Designs process improvements to reduce product cost, process cycle time and improved product quality.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Create documentation to support new and improved manufacturing processes
Write and perform process validations
Make recommendations for equipment purchases based upon manufacturing needs
Perform IQ/OQ/PQ as required on equipment
Disposition NCR’s and CAPA’s as assigned
Perform experiments including but not limited to DOE’s to characterize and improve processes
Interface directly with assemblers, production supervisors, leads, engineers, and management on a routine basis
Coordinate with suppliers and external resources needed in developing and implementing new processes
Work closely with R&D and Manufacturing to capture and interpret design intent in order to refine and improve processes
Facilitate excellent communications between all team members
Responsible for communicating business related issues or opportunities to next management level
For employees with supervisory responsibilities, ensure that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition
Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
Responsible for ensuring compliance with Quality Procedures, Laws and Regulations of the applicable markets
Performs other duties assigned as needed

Skills

5-7 years related work experience, preferably in a medical device manufacturing environment preferred

Excellent hands?on communication and interpersonal skills

Experienced in MS Word, Excel, and Project

Experience in Design for Manufacturing (DFM), Design of Experiments (DOE) and product/process. Failure Mode and Effects Analysis (FMEA)

Experience with CAD Software (Solid Works & AutoCAD) preferred

Strong Lean Manufacturing background preferred.

Experience in a Controlled Room environment preferred i.e cleanroom (CER)

Must be able to multi?task and operate in a fast-paced environment with minimal training and supervision.

Strong written, verbal, and interpersonal skills.

Ability to effectively interact with all levels of employees and management, both in the Manufacturing group and cross?functionally

Excellent computer skills ? including advanced working knowledge of Microsoft Office (Word, Excel, Outlook, etc.)

Understanding of regulations related to FDA, GMP/MDD, and ISO preferred.

What is expected of you and others at this level

Applies working knowledge in the application of concepts, principles, and technical capabilities to perform varied tasks
Works on projects of moderate scope and complexity
Identifies possible solutions to a variety of technical problems and takes actions to resolve
Applies judgment within defined parameters
Receives general guidance may receive more detailed instruction on new projects
Work reviewed for sound reasoning and accuracy

ADDITIONAL POSITION REQUIREMENTS

Work includes potential exposure to human blood borne pathogens or other potentially infectious materials. Work includes potential exposure to radiation sources such as fluoroscope in a catheter laboratory setting. Work includes potential exposure to chemicals.

Education

Bachelor degree required – some majors that would fit the role are below with the priority also in order:

Biomedical Engineer
Chemical Engineer
Mechanical Engineer