Manufacturing Engineer II - Med Device Process Innovator

LSI SOLUTIONS, Inc.; New York (NY); On-site; USD 80,000 - 110,000; Full time

Benefits offered by this job

Bonus Plan

401(k) Plan

Tuition Assistance

Employee Assistance Program

Product Discounts

Paid Holidays

PTO & Sick Time

Medical/Dental/Vision

Job summary

LSI SOLUTIONS®, located in Victor, NY, seeks a Manufacturing Engineer II to develop and improve manufacturing processes and production equipment. The role focuses on reducing waste, boosting productivity, and elevating product quality in a regulated medical device environment.

The ideal candidate will apply Lean, Six Sigma, and design-for-manufacturing principles, perform validations, and collaborate across functions to sustain regulatory compliance and on-time production.

Qualifications

• BS Engineering or Engineering Technology degree.
• 2–5 years of relevant experience in manufacturing engineering.
• Experience in medical device or pharma preferred.

Responsibilities

• Develop manufacturing processes meeting internal and external requirements.
• Specify, purchase, implement, and support new equipment.
• Create Process Control Plans.
• Provide technical support to production teams to resolve issues.
• Identify opportunities for continuous improvement.
• Contribute to process risk analysis activities.
• Ensure validation and MSA for test equipment.
• Update equipment specifications and documentation.
• Support fixture and tool development for production needs.
• Ensure compliance with safety regulations and ISO/medical standards.

Skills

Lean methodology

Six Sigma

5S

Value Stream mapping

Takt time

Design for Manufacturing

FMEA

Production readiness

Cell layout

3D CAD

GD&T

Problem solving

FDA QSR

ISO 13485

Statistical analysis

Education

BS Engineering or Engineering Technology

Tools

3D CAD software

Engineering software

Job description

LSI SOLUTIONS®, located in Victor, NY, seeks a Manufacturing Engineer II to develop and improve manufacturing processes and production equipment. The role focuses on reducing waste, boosting productivity, and elevating product quality in a regulated medical device environment.

The ideal candidate will apply Lean, Six Sigma, and design-for-manufacturing principles, perform validations, and collaborate across functions to sustain regulatory compliance and on-time production.