Product development from concept to commercialization
Fda/iso design control standards
Risk management, verification/validation
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
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.
Duties include mentoring engineers, collaborating on strategy, building relationships with KOLs and surgeons, defining engineering scope, approving testing protocols, and ensuring product designs meet FDA/ISO standards.
The role requires strong technical expertise in CAD, GD&T, risk management, and familiarity with FDA/ISO regulations, with preferred advanced skills in patent analysis and technical writing.
Matching 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.
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)
surgical anatomy, techniques, and products
Nice-to-have
mentor and/or supervise engineers
shape corporate and technical strategy
build and manage relationships with external resources
influence product direction
partner with manufacturing on new technologies
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
Lead large, complex projects
Proficiency with 3D/2D CAD software
Familiarity with FDA Quality System Regulations (21 CFR Part 820) and ISO 13485