Jobs

Description

2nd shift

Description:

• Must be onsite
• Looking specifically for manufacturing engineers with medical device or pharmaceutical experience.

Summary of Duties and Responsibilities:

• Create and execute validation plans, including IQ of process equipment and OQ and or PQ of manufacturing processes.
• Lead manufacturing implementation of sustaining design initiatives.
• Detect, conceptualize, and execute improvement opportunities using a series of Lean and related tools and methodologies.
• Distill complex technical situations into meaningful summaries that are digestible by various stakeholders.
• Lead troubleshooting exercises to quickly get to solutions.
• Create and revise essential documents such as process flowcharts, PFMEA, and Process Control plans.

Qualifications

• Medical device industry experience
• Extensive validation experience, including employment of sound statistical approach and authorship of solid protocols and or reports.
• Advanced inter-personal skills, communication and emotional awareness is key to be successful in this role.
• Quick learner, driven and not afraid to experiment.
• Ability to manage projects and lead and coordinate cross-functional teams.

Education

• B.S. Engineering preferably in Mechanical, Electro-Mechanical, Electrical, or Industrial Engineering

Experience

• 7or more years’ experience in Manufacturing and or Manufacturing Engineering with working knowledge of electro-mechanical sub-assemblies.

Physical Demands

A thorough completion of this section is needed for compliance with legal standards such as the Americans with Disabilities Act. The physical requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Sit; use hands to finger, handle or feel objects, tools, or controls. Repetitive hand motion.
• Stand; walk; reach with hands and arms; and stoop, kneel, crouch, or crawl.
• Lifting and or moving and carrying products weighing up to 50 pounds.
• Exposure to moving mechanical parts, vibration and or moderate noise levels.
• Exposure to hazardous chemicals or other materials.
• May work with or around high voltage and radiation generating equipment.
• Safety shoes with impact and compression protection must be worn in designated areas.

Job Summary:

• The Manufacturing Engineer 3 Senior Manufacturing Engineer provides a key technical interface to a critical contract manufacturing relationship.
• The contract manufacturer provides a system consisting of electromechanical capital equipment as well as high-volume sterile disposables.