Product development from concept to commercialization
Fda/iso design control standards
Risk management, verification/validation
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Ameritrack LLC is seeking a Staff Product Development Engineer for its Addison, Texas location. The role involves driving product development in the medical device sector, focusing on collaboration, mentorship, and compliance with industry standards.
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Job Summary
The Staff Product Development Engineer drives product development from concept to commercialization — including research, planning, concept creation, specifications, testing, validation, and communication with teams, management, and customers.
Ensure product designs and documentation meet FDA/ISO design control standards, including risk management, verification/validation, and proper use of CAD/PLM and ERP systems (e.g., GD&T, ECO/ECR, SAP).
The company is committed to making a positive impact on the world, providing diverse learning and working opportunities, and fostering a culture where everyone is empowered to be their best.
Matching Summary
Match Score: 75
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Ameritrack LLC is seeking a Staff Product Development Engineer for its Addison, Texas location. The role involves driving product development in the medical device sector, focusing on collaboration, mentorship, and compliance with industry standards.
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Skills & Requirements
Must-have
product development from concept to commercialization
FDA/ISO design control standards
risk management, verification/validation
CAD/PLM and ERP systems
Geometric Dimensioning & Tolerancing (GD&T)
Nice-to-have
independent patent analysis
writing technical product papers
proficiency in multiple technical specialty areas
Key Requirements
Bachelor’s degree in Mechanical or Bio-Mechanical Engineering with 8+ years’ experience
14+ years in medical device development
Ability to mentor/supervise engineers
Strong knowledge of surgical anatomy, techniques, and products
Familiarity with FDA Quality System Regulations (21 CFR Part 820) and ISO 13485