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Acumed · 2 weeks ago

Staff Product Development Engineer - Foot & Ankle

Addison, TX

Full-time

Onsite

Lead/Staff

$127K/yr - $155K/yr

8+ years exp

Acumed LLC is part of the global industrial organization Marmon Holdings, backed by Berkshire Hathaway. The Staff Product Development Engineer drives product development from concept to commercialization, overseeing complex projects and collaborating with various teams to ensure compliance with FDA/ISO standards.

Health CareManufacturingMedical Device

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

Qualification

Mechanical EngineeringBio-Mechanical Engineering3D/2D CAD softwareGeometric Dimensioning & TolerancingFDA Quality System RegulationsISO 13485Clinical InsightMarket AnalysisLeadershipTechnical Writing

Required

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, and 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, and recommending ROI

Preferred

Independent patent analysis; writing technical product papers; proficiency in multiple technical specialty areas; ability to serve as independent reviewer for multiple projects