Product Development Engineer - Foot & Ankle

Overview

Join to apply for the Staff Product Development Engineer - Foot & Ankle role at Acumed
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Acumed LLC — part of Marmon Holdings (backed by Berkshire Hathaway) — offers opportunities to impact the world, learn, and grow within a culture that empowers everyone to do their best.

Location: Addison, Texas

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.

• 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.

• 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, GD&T, tolerance analysis, and familiarity with FDA QSR (21 CFR Part 820) and ISO 13485.
• Clinical & Market Insight:
  Engages with HCPs and surgeons, organizes cadaver labs, investigates product opportunities, analyzes market/competition, and recommends 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.

Target Compensation: $ – $

Medical, Dental, and Vision insurance, 401k matching, + more.

Following receipt of a conditional offer of employment, candidates will be required to complete additional job-related screening processes as permitted or required by applicable law.

We are an equal opportunity employer, and all applicants will be considered for employment without attention to their membership in any protected class. If you require any reasonable accommodation to complete your application or any part of the recruiting process, please email your request to , and include the title and location of the position.

• Mid-Senior level

• Full-time

• Engineering and Information Technology

• Medical Equipment Manufacturing

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