Senior MedTech Product Development Engineer

ARCH; Kenosha (WI); On-site; USD 108,000 - 132,000; Full time

Job summary

ARCH in Kenosha, Wisconsin is seeking a senior engineer to lead design and development of medical devices. The role involves prototyping, testing, and refining processes while maintaining thorough documentation.

You will work with CAD tools, review customer prints for accuracy, and drive cost estimates, schedules and quality standards to meet print specifications. A strong leadership presence and PM skills are essential for success in this manufacturing environment.

Qualifications

• Bachelor's degree in Engineering or Manufacturing Engineering or equivalent.
• Five to ten years of experience in production management and/or training.
• Proven track record in medical device design and development.
• Knowledge of emerging trends and ability to influence best practices in Medical Device development.
• Knowledge of Geometric Dimensioning and Tolerancing per ASME Y14.5M.
• Knowledge of ISO 13485 Quality Management System & FDA 21CFR 820 Regulations.
• Strong leadership and project management skills.

Responsibilities

• Design, test, modify, fabricate and assemble prototypes and document development process.
• Use CAD tools for design work and CAD documentation.
• Set design specifications and calibrations; adjust as needed.
• Evaluate existing tech; implement new materials and processes.
• Review customer prints for accuracy against specs and quality standards.

Skills

Medical device design

Leadership

Project management

Quality systems

Continuous improvement

Design for manufacturability

Emerging trends awareness

Education

Bachelor's degree in Engineering / Manufacturing Engineering

Tools

CAD software

Drafting tools

Job description

ARCH in Kenosha, Wisconsin is seeking a senior engineer to lead design and development of medical devices. The role involves prototyping, testing, and refining processes while maintaining thorough documentation.

You will work with CAD tools, review customer prints for accuracy, and drive cost estimates, schedules and quality standards to meet print specifications. A strong leadership presence and PM skills are essential for success in this manufacturing environment.