Medical Device Development Engineer

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/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.

Qualifications

• Education/Experience: Bachelor’s degree in Mechanical or Bio-Mechanical Engineering with 8+ years’ experience preferred; or 14+ years in medical device development.
• Leadership: Ability to mentor/supervise engineers, mechanical drafters, and product designers; lead large, complex projects; communicate effectively with executives and cross-functional teams.
• Technical Expertise: 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, and familiarity with FDA Quality System Regulations (21 CFR Part 820) and ISO 13485.
• Clinical & Market Insight: Effective at engaging with HCPs and surgeons, organizing cadaver labs, investigating new product opportunities, analyzing market/competition, and recommending ROI.
• Advanced Skills (Preferred): Independent patent analysis; writing technical product papers; proficiency in multiple technical specialty areas; ability to serve as independent reviewer for multiple projects.