Biomedical Product Engineer: Design, Validation & Compliance

The Metrix Company; Dubuque (IA); On-site; USD 70,000 - 95,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

401k retirement plan with generous employer match

Job summary

The Metrix Company is seeking a Product Engineer responsible for developing and testing new products in compliance with customer needs and regulatory requirements. This role emphasizes collaboration with manufacturing and cross-functional teams throughout the product lifecycle.

Qualified candidates should hold a Bachelor’s degree in Engineering and have 1-3 years of relevant experience, including knowledge of FDA and ISO regulations. The company offers competitive compensation and a comprehensive benefits package.

Qualifications

• 1-3 years of related engineering experience.
• Understanding of ISO 13485, ISO 14971, and FDA 21 CFR 820 regulations.
• Technical knowledge of electro-mechanical methods and tools.

Responsibilities

• Lead new product development and manage design control activities.
• Collaborate with contract customers for product inquiries and designs.
• Ensure compliance with regulatory requirements for product designs.

Skills

SolidWorks

Design control activities

Regulatory compliance (FDA, ISO)

Technical drawing interpretation

Education

Bachelor of Science in Biomedical, Mechanical, or Industrial Engineering

Tools

Microsoft Word

Microsoft Excel

Microsoft Outlook

Job description

The Metrix Company is seeking a Product Engineer responsible for developing and testing new products in compliance with customer needs and regulatory requirements. This role emphasizes collaboration with manufacturing and cross-functional teams throughout the product lifecycle.

Qualified candidates should hold a Bachelor’s degree in Engineering and have 1-3 years of relevant experience, including knowledge of FDA and ISO regulations. The company offers competitive compensation and a comprehensive benefits package.