Manufacturing Engineer - 1st Shift jdd

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Modify manufacturing processes for existing products that will reduce operating costs, labor, and improve overall production yield.

Design and develop process tooling and equipment ranging from simple fixtures to complex automated equipment.

Plan, coordinate, develop and execute test protocols, experiments, process characterization and process validations (IQ, OQ, PQ) on new and revised products and manufacturing processes.

Conduct PFMEA on new and existing manufacturing processes.

Write and update standard operating procedures.

Train production staff on new or revised processes.

Participate in DFM with design and development engineering team for new product lines.

Conduct time studies on new and existing production operations to identify improvement areas and/or gauge production capacity.

Create process maps and conduct process simulation analysis.

Provide timely resolution of product, process and equipment problems in the form of creative short and long term solutions

Assist in technical support and troubleshooting for manufacturing processes or equipment.

Assists RA/QA and manufacturing teams in root cause analysis.

Research and develop proposals for new equipment and machinery. Prepare cost justifications via payback, IRR, rate of return, etc.  Contract with outside services firms for machine installation and setup.

Recommend and document equipment preventative maintenance and calibrations requirements.

Stay current in QA/RA SOP's.

Provide support as required to GMP, safety, ISO and internal audits.

REQUIREMENTS

Knowledge and experience working within an ISO 13485 compliant business systems.

Demonstrated use of DFSS (DOE, problem solving).

Understanding of DFM, medical device design control / quality systems and the product development process.

Knowledge in manufacturing processes such as UV adhesive bonding, ultrasonic welding, catheter assembly processes (punching, tipping, packaging).

Demonstrate strong oral and written communication skills.

Good interpersonal skills.

Eagerness to learn and expand responsibilities.

Experience with Autodesk CAD Products: AutoCAD, Inventor, and simulation software.

Working understanding of GD&T dimensioning.

Experience managing supplier activities and discussing requirement specifications.

Strong mechanical and machining skills to independently design and build manual or automated manufacturing equipment.

Experience with PLCs, robots, motion controls and associated programming software.

EDUCATION AND EXPERIENCE

Bachelor of Science degree in Manufacturing, Mechanical, Industrial Engineering or equivalent degree.

5+ years in a medical device manufacturing environment developing new or improving current manufacturing systems and processes.

Experience designing/developing parts and assemblies in 3D CAD applications.

Demonstrated application of engineering principles and techniques to solve problems technical in nature.

Demonstrated use of word processing and spreadsheet applications.

BENEFITS

Medical, Dental, and Vision insurance

Company paid life insurance

Paid Time Off

Paid Holidays

Employee Assistance Program

401k w/ employer match

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