Manufacturing Engineer

MVE Biological Solutions is the leading global manufacturer of vacuum insulated products and cryogenic systems. More than 50 years ago, they set the standard for storage of biological materials at low temperatures. Today, they continue to exceed these standards. Industries from around the world look to MVE for excellence and innovation. Their solutions empower industries to better utilize cryogenic technology. In this manner, MVE continues to make a vital contribution in today’s biomedical life sciences industry.

Position Summary:

The Manufacturing Engineer provides support and solutions by leveraging general knowledge of manufacturing processes to increase plant efficiencies and meet, or exceed, goals related to safety, quality and production. The Manufacturing Engineer will also regularly employ software tools to aggregate test data, troubleshoot equipment, and develop layout drawings. The ideal candidate will demonstrate deep technical knowledge, excellent communication and organizational skills, and strong personal ownership of initiatives.

PRIMARY RESPONSIBILITIES (include but not limited to)

Plan, organize and implement systems and procedures for aiding in the manufacturing of MVE products while enhancing flow, and implement Lean concepts (e.g. 5S, Visual Work, Kanban) throughout the plant

Personally conduct and/or supervise studies to determine cause, effect and the corrective measures required to remedy deviations impairing desirable standards of quality

Analyze and plan workflow, equipment placement and space requirements to improve manufacturing efficiency

Partner with the Design Engineering groups to ensure that all aspects of new product introduction and changes to existing products are properly transitioned into manufacturing

Develop and perform qualification and validation activities for newly introduced equipment, processes, & products

Partner with production, engineering, and maintenance departments and apply formal problem solving tools (e.g. 5 Why’s, 8D, Ishikawa diagram) to resolve assembly errors and eliminate variances

Work closely with team members to identify and eliminate waste activities

Identify, recommend, and justify opportunities for capital equipment improvements

Project Management of Capital equipment projects, and ensuring on time delivery, managing budgetary constraints, and ROI

Perform hands-on mechanical and electrical troubleshooting of production equipment, including some PLC troubleshooting

Observe and promote safety procedures and policies

Other duties and responsibilities as assigned by management

COMPETENCIES AND PERSONAL ATTRIBUTES:

Must possess a working knowledge of computers, including MS Word, Excel, and SolidWorks

General familiarity of medical device or similar quality systems requirements

Understanding of MIG/TIG welding practices, sheet metal fabrication, cryogenics, and vacuum systems, a plus

Understanding of factory metrics, Lean (Operational Excellence) and Six Sigma, a plus

Knowledge and understanding of company safety procedures and policies

Awareness and understanding of Company quality standards, capital equipment, procurement, FMEA, APQP, ISO 13485, MDD/MDR, FDA

Team player mentality with a passion for, and alignment with, MVE’s mission

An individual who brings strong core values, quality, ethics, and integrity

A team player who embraces and champions the culture of collaboration and accountability

Strong work ethic and ability to deliver results and meet commitments in a dynamic environment

Exceptional and dynamic communication skills with the ability to inspire and influence others

An individual who works efficiently, effectively prioritizes and drives towards our corporate goals

Exceptional organizational and planning skills, strong analytical abilities, and process orientation

Demonstrates a business process orientation to developing solutions

QUALIFICATIONS AND EDUCATION REQUIREMENTS

BS degree in Engineering, preferably Manufacturing, Mechanical or Industrial

3 –5 years of relevant Medical Device Manufacturing experience; or a minimum of 10 years of experience in a related field. Experience must reflect increase in scope and complexity of duties and responsibilities.

Six Sigma Black Belt certification required, with a proven track record of leading and delivering measurable process improvement projects.

PHYSICAL WORK ENVIRONMENT REQUIREMENTS

Ability to work in both an office and production environment

Occasional travel to customers, vendors, or other MVE locations is possible

Ability to sit, stand, and/or walk for 8 hrs/day

Occasional lifting of up to 30 lbs., occasional heavier lifting

Occasional pushing, pulling and handling of materials

Production floor environment will involve possible exposure to materials with rough edges, temperature extremes, moving mechanical parts, occasional flying debris, chemical cleaning solvents and their odors

This position will require the ability to move around the production floor and lab areas to address production issues relating to products and equipment

Working with cryogenic products will involve possible exposure to pressurized flammable gas, pressurized oxidizing gas, pressurized inert gas and very low temperatures (-320º F)