Staff Product Development Engineer - Hand & Upper Extremity

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.

Responsibilities

Mentor and/or supervise engineers and designers across multiple projects; Collaborate with department leaders to shape corporate and technical strategy; Build and manage relationships with external design resources, KOLs, and surgeons; Define and oversee engineering scope and deliverables for complex projects; Develop and approve advanced testing protocols, methods, and Engineering Change Requests (ECRs); Act as internal reviewer/approver for Clinical Data Reports (CDRs); Guide business development and R&D with technical expertise and market insight; Participate in technical review boards and influence product direction; Partner with manufacturing on new technologies and processes; 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); Organize and support cadaver labs with surgeons and design teams

Requirements

Bachelor’s degree in Mechanical or Bio-Mechanical Engineering with 8+ years’ experience preferred, or 14+ years in medical device development; Ability to mentor/supervise engineers, mechanical drafters, and product designers; Lead large, complex projects; Communicate effectively with executives and cross-functional teams; Skilled in creating and advising on highly complex testing protocols, methodologies, and technologies; Strong knowledge of surgical anatomy, techniques, and products; Ability to independently develop solutions and intellectual property; Proficiency with 3D/2D CAD software, Geometric Dimensioning & Tolerancing (GD&T), tolerance stack analysis; Familiarity with FDA Quality System Regulations (21 CFR Part 820) and ISO 13485; Effective at engaging with HCPs and surgeons; Organizing cadaver labs; Investigating new product opportunities; Analyzing market/competition; Recommending ROI

Nice to have

Independent patent analysis; Writing technical product papers; Proficiency in multiple technical specialty areas; Ability to serve as independent reviewer for multiple projects