Design Assurance Engineer II – Medical Device Quality

integer; New York (NY); On-site; USD 71,000 - 105,000; Full time

Job summary

Integer is seeking a Design Assurance Engineer II to support new product development and ensure FDA/European regulatory compliance. The role includes transferring products to production and coordinating design activities across departments.

Ideal candidates will have a strong engineering foundation, 3+ years in related roles, and exposure to quality systems such as QMS, Six Sigma, and regulatory standards. This position emphasizes teamwork, problem solving, and ongoing improvement within

Qualifications

• Bachelor’s degree in engineering or a related technical field.
• 3+ years of progressive engineering experience.
• Experience with quality systems and regulatory compliance.
• Strong problem solving and leadership skills.

Responsibilities

• Initiate and manage design and development of new products from concept to manufacturing.
• Coordinate with cross-functional teams to align design activity.
• Review engineering drawings, specifications and change orders.
• Plan tooling, process flow, and capability studies.
• Embed quality throughout the engineering process and drive continuous improvement.

Skills

Problem solving

Team collaboration

Communication

Quality mindset

Education

Bachelor's degree in engineering

Tools

Six Sigma

8D

RCA

5-Why

Ishikawa

Kepner-Tregoe

PMP

Job description

Integer is seeking a Design Assurance Engineer II to support new product development and ensure FDA/European regulatory compliance. The role includes transferring products to production and coordinating design activities across departments.

Ideal candidates will have a strong engineering foundation, 3+ years in related roles, and exposure to quality systems such as QMS, Six Sigma, and regulatory standards. This position emphasizes teamwork, problem solving, and ongoing improvement within