Sr. Manufacturing Engineer (North Haven)

This is a 100% on-site Sr. Manufacturing Engineer opening with a global medical device client for a project team in North Haven, CT. This will be supporting remediation activities at the site as they revamp and redesign packaging and sterilization processes.

This candidate should have strong experience with oversight of small projects (ideally $1M+ budgets ). Candidates should have exposure to Medical Devices , and it is preferred that they have experience with packaging equipment and sterilization systems.

Candidates should have strong experience with Process Validation (IQ / OQ / PQ), management of equipment vendors, and the ability to present to Senior Leadership on project status.

Products : Sutures and other absorbable wound care products

Interview Process : Likely a call with Manager and one team member. May require a follow-up discussion, but unlikely.

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

Top 3 Skills :

• Project Management for small to medium sized projects
• Experience with post-processing and packaging related capital equipment
• Process and Equipment Validations (IQ, OQ, PQ)

Education Required : Bachelors degree in Engineering, preferably in Manufacturing or Mechanical

Years Experience Required : 48 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 the 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 efficiency and initiates corrective actions to ensure product quality.
• Develops manufacturing processes applicable to statistical process control and may develop related techniques.
• Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.
• Ensures processes and procedures comply 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
• DOE and Test Method Validation for development / optimization of new processes
• Managing Gantt charts and tracking deliverable timelines
• Experience with manual and automated capital equipment
• Presenting project status to leadership teams

Preferred Skills :

• Packaging and Sterilization equipment experience
• Exposure to sterile barrier packaging systems (bar sealing, foil, Tyvek, film-based blister packs, trays, and pouches) and post-processing equipment (vacuum drying ovens)
• Experience with Agile
• Experience (read-only) with Planisware or similar systems