Senior Manufacturing Engineer – Medical Device NPI

Excelon Solutions; Plymouth (MN); On-site; USD 90,000 - 120,000; Full time

Job summary

Excelon Solutions in Plymouth, MN is seeking a Manufacturing Engineer with 5+ years in manufacturing engineering, preferably in medical devices. You will design test fixtures, develop test methods and validation plans, and support tooling/equipment development.

The role requires independence and ability to work with cross-functional, global teams across the product lifecycle, with emphasis on process development and process validation.

Qualifications

• Bachelor's degree in Mechanical Engineering or related field.
• 5+ years in manufacturing engineering, preferably in medical devices.
• Experience with design for manufacturability and process validation (IQ/OQ/PQ).
• Experience in process development, characterization, and test fixture design.
• Ability to work independently and in cross-functional, global teams.
• Knowledge of manufacturing processes and product development lifecycle.

Responsibilities

• Design and develop test fixtures.
• Develop test methods and inspection methods and perform validation.
• Support tooling and equipment development.
• Collaborate with cross-functional teams to meet product specs.
• Understand product design requirements and lifecycle management.

Skills

Process development

Process validation

IQ/OQ/PQ

Test fixtures design

Test methods

Cross-functional teams

Manufacturing processes

Design for manufacturability

Tooling/equipment development

Education

Bachelor's degree in engineering

Master's degree preferred

Job description

Excelon Solutions in Plymouth, MN is seeking a Manufacturing Engineer with 5+ years in manufacturing engineering, preferably in medical devices. You will design test fixtures, develop test methods and validation plans, and support tooling/equipment development.

The role requires independence and ability to work with cross-functional, global teams across the product lifecycle, with emphasis on process development and process validation.