Senior Medical Device Product Development Engineer

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

Job summary

ARCH Cutting Tools in Kenosha, Wisconsin is seeking an experienced engineering/production leader to guide medical device design, testing, and manufacturing improvement efforts. You will work with CAD tools, calibrate designs to specifications, and drive cost and schedule targets while ensuring quality and documentation.

You will lead cross-functional teams, develop new methods and materials, and contribute to a manufacturing-ready product strategy in a fast-paced environment.

Qualifications

• Bachelor's degree in Engineering or equivalent required.
• 5–10 years experience in production management and/or training preferred.
• Proven track record in medical device design and development.
• Knowledge of GD&T per ASME Y14.5M; ISO 13485 and FDA 21CFR 820 knowledge valuable.

Responsibilities

• Support and participate in design, test, modification, fabrication and assembly of prototypes with thorough documentation.
• Utilize CAD tools for design work and ensure design specs; calibrate as needed.
• Investigate and implement new methods, materials, and processes for product development.
• Lead and collaborate with cross-functional teams to meet design inputs, schedules and costs.
• Create manufacturing Bills of Materials and ensure alignment with production and quality standards.
• Promote safety, quality and continuous improvement on the shop floor.

Skills

Leadership

Project management

GD&T

Medical device design

Education

Bachelor's degree in Engineering

Job description

ARCH Cutting Tools in Kenosha, Wisconsin is seeking an experienced engineering/production leader to guide medical device design, testing, and manufacturing improvement efforts. You will work with CAD tools, calibrate designs to specifications, and drive cost and schedule targets while ensuring quality and documentation.

You will lead cross-functional teams, develop new methods and materials, and contribute to a manufacturing-ready product strategy in a fast-paced environment.