Sr. Manufacturing Engineer

**CANDIDATES CURRNETLY WORKING UNDER F1 OPT/F1 OPT STEM/H1-B WILL NOT BE CONSIDERED. W2 CANDIDATES ONLY**

Sr. Manufacturing Engineer (12-month contract // North Haven, CT):

Alternative Title: Sr. Project Engineer

Top 3 Skills:

1. Project Management for small to medium sized projects, including development of project plans and project charters
2. Experience with post-processing and packaging related capital equipment
3. Process and Equipment Validations (IQ, OQ, PQ)

Education Required: Bachelor’s degree in Engineering, preferably in Manufacturing or Mechanical

Years’ Experience Required: 4-8 years of experience with Manufacturing Engineering and Project Management

Duties:

• Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining, and material handling.
• Designs arrangement of machines within plant facilities to ensure most efficient and productive layout.
• Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance.
• Adapts machine or equipment design to factory and production conditions. May incorporate inspection and test requirements into the production plan.
• Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality.
• Develops manufacturing processes that are applicable to statistical process control, and may develop those techniques.
• Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques. Ensures processes and procedures are in compliance with regulations.

Required Skills:

• Project Management for small to medium sized projects with core/external teams
• IQ, OQ, PQ Validations
• Experience working in a Medical Device setting
• Experience with DOE and Test Method Validation for development/optimization of new processes
• Experience managing Gannt charts and tracking deliverable timelines
• Experience with a range of manual and automated capital equipment
• Experience presenting project status to leadership teams

Preferred Skills:

• Packaging and Sterilization equipment experience
• Ideal equipment exposure would be sterile barrier packaging systems (bar sealing, Foil, Tyvek, and film-based blister packs, trays, and pouches) and post processing equipment (vacuum drying ovens)
• Experience with Agile
• Experience on a read-only basis with Planisware or similar systems