Product Engineer

Job Overview

Position Summary

The Metrix Company, a leading manufacturer of single-use medical devices, has an exciting opportunity to join our team as a Product Engineer! This position works directly with the Engineering Manager and is responsible for developing and testing new products in accordance with customer needs and regulatory requirements. The Product Engineer works with the Manufacturing Engineer transitioning product designs to the production floor. The Product Engineer is responsible for design process, material and sourcing investigations, product cost analysis, product validations and initiating corrective action investigations.

Responsibilities

• Lead and manage new product development using design control activities, including design inputs, outputs, design reviews, verification, validation, and design to production transfer meetings.
• Collaborate with contract customers for new product inquiries, develop new contract product designs, and support existing products.
• Lead and document formal design reviews at defined project phases.
• Ensure product designs comply with applicable regulatory requirements, including FDA regulations (21 CFR 820) and ISO 13485, as applicable.
• Develop and manage design verification and validation protocols and reports for product and component testing, including coordination with external testing laboratories.
• Identify, evaluate, and collaborate with component suppliers for new and existing products.
• Develop product specifications, drawings, work instructions, test methods, inspection criteria, and Bills of Materials.
• Design and develop production tooling and fixtures to support manufacturing.
• Develop and maintain Design History Files (DHF), Device Master Records (DMR) and Contract Product History Files, as applicable.
• Investigate design, material, and supplier-related issues and implement corrective and preventive actions as needed.
• Perform product cost analysis and implement design and process improvements to reduce product and manufacturing costs.
• Collaborate with cross-functional teams during new product development and production support.
• Initiate and manage Document Change Orders (DCOs) for product updates and improvements.
• Support risk management activities, including design risk analysis (e.g., FMEA), and implement appropriate mitigation strategies.

Qualified candidates will possess a Bachelor of Science degree in Biomedical, Mechanical, or Industrial Engineering with 1-3 years of related experience. An understanding of ISO 13485, ISO 14971 and FDA 21 CFR 820 regulations is preferred. Candidates must be proficient in SolidWorks or related CAD software, Microsoft Word, Excel, and Outlook and reading technical drawings and specifications. Technical knowledge of electro-mechanical, radio frequency, heat seal and film welding methods, machines, and tools is preferred.

The Metrix Company offers an excellent compensation and benefits package, including health, dental, optical, life, disability insurance, and 401k retirement plan with a generous employer match.

Candidates must be authorized to work in the United States. Employer will not sponsor applicants for work visas.