MILLENNIUMSOFT is hiring: Manufacturing Engineer in Zelienople

Position : Manufacturing Engineer

Location : Zelienople, PA

Duration : 6 Months Contract

Total Hours/week : 40.00

1st shift

Description:

• This Manufacturing Engineering position will be the plant point of contact for design transfers and will be responsible for supporting manufacturing and service of Targeted Temperature Management (TTM) Products by developing, qualifying, implementing and maintaining manufacturing equipment, processes and procedures.

Duties and Responsibilities:

• Lead the product transfer effort (receiving facility) on new TTM product introduction projects to concurrently develop assembly and testing methods and equipment.
• Support existing manufacturing product line(s) from the TTM division.
• Lead validation efforts for TTM-related processes and equipment.
• Lead engineering build and pilot run executions.
• Participate in design reviews representing manufacturing
• Develop and maintain specifications and procedures for manufacturing, test and inspection processes.
• Design, develop, specify, acquire/manufacture, qualify and maintain manufacturing & test fixtures, tooling and equipment.
• Develop and execute test protocols, author test reports, technical memos, investigations and document changes in accordance with regulatory and corporate requirements.
• Trouble-shoot processes, designs, and equipment.
• Assist in the selection and qualification of vendors for the procurement of production materials and equipment
• Manage the total manufacturing cost for all TTM products and accessories.
• Responsible for the production line efficiency improvements (processes, layouts, fixtures/tooling, etc). Utilize Lean tools to eliminate waste, increase capacity, and drive cost out of the process for TTM products and accessories.
• Perform root cause analysis. Develop and implement corrective actions.
• Lead multiple engineering projects. Examples:
• Manufacturing & service support tasks.
• Continuous improvement projects.
• Qualifications and validations (IQ, OQ, PQ’s) of processes and/or equipment.
• Investigations (root cause analysis, failure analysis, replacement materials/equipment).
• Product transfers.
• Equipment Maintenance Projects
• Creation and set up prototype production lines.
• Pilot production runs.
• Maintain working knowledge of company policies and procedures, ISO and FDA requirements.
• Other TTM related duties as assigned.

Qualifications:

• Bachelor’s degree in an engineering discipline.
• 5+ years experience in a manufacturing environment in a regulated industry, medical device preferred.
• Experience with hands-on electro-mechanical assembly and troubleshooting.
• Knowledgeable in troubleshooting electromechanical systems.
• Ability to read and understand mechanical drawings and electrical schematics.
• Demonstrated ability to gather, analyze and evaluate data as well as recommend actions.
• Lean/Six Sigma experience preferred
• Experience working closely with design engineering, quality engineering and production personnel.

• Computer skills: Word, Excel, Powerpoint

Additional Desirable Qualifications Skills and Knowledge:

• PFMEA/Risk analysis.
• Fixture design experience.
• Excellent verbal and written communication skills.
• Time management and organizational skills.
• Demonstrated problem solver & team player.
• Experience with drafting/CAD/3D modeling.
• Familiarity with FDA regulatory requirements, GMP, ISO, process validation.

Physical Demands:

• While performing the duties of this job, the employee is regularly required to stand, walk, sit, and use hands to manipulate, handle, or feel objects, tools, controls and office equipment.
• The employee frequently is required to talk and hear.
• The employee is occasionally required to reach with hands and arms, and stoop, kneel, or crouch.

Work Environment:

• While performing the duties of this job, the employee may be in an office, open cubicle, and/or manufacturing environment.
• Candidate must be able to work in a team-oriented, fast-paced environment. C. R. Bard is an equal opportunity employer that values and actively seeks diversity in the workforce.