Staff Product Development Engineer - Hand & Upper Extremity

About the role

The Staff Product Development Engineer at Acumed LLC plays a crucial role in driving product development from concept to commercialization. This includes responsibilities such as mentoring and supervising engineers and designers, collaborating with department leaders to shape corporate and technical strategy, defining and overseeing engineering scope and deliverables for complex projects, and ensuring product designs and documentation meet FDA/ISO design control standards.

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.
• 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.