Product Development Engineer

Champion Healthcare Solutions • Ocala, FL

35d • Onsite

About The Position

From the very beginning, Champion has been 100% focused on medical seating. We pride ourselves in being at the forefront of the industry to provide our customers with innovative, clinically effective solutions that improve performance for both patients and caregivers. We continue to set the standard for medical seating, and partner with healthcare organizations to support the industry’s transformation into an all-inclusive, human-centric experience. The Product Development Engineer is responsible for the design support, refinement, and release of mechanical and electromechanical components and assemblies used in Champion’s Class I and Class II medical products. This position focuses on New Product Introduction (NPI) and mechanical design transfer ensuring that engineered components are manufacturable, documented correctly and validated for production.

Requirements

• Bachelor’s degree in mechanical engineering, or equivalent experience.
• 7+ years of product development experience required; 10+ years preferred with demonstrated ownership of NPI/NPD launches in regulated industries.
• Proficiency in 3D CAD (SolidWorks) for part/assembly/drawing creation.
• Ability to work onsite in a manufacturing environment and communicate design intent via drawings and BOMs.
• Ability to manage engineering changes and maintain design data within a PDM/ERP system.
• Full product CAD ownership including frames and mechanisms, powered actuators, control components, and integrated power systems in large assemblies.
• Mechanism design for medical seating
• Structural analysis using Inventor/Nastran for seating frames, weldments and load-bearing components.
• Design Controls under ISO 13485 and 21 CFR 820 (Design inputs/outputs, verification/validation, DHF/DMR).
• Risk management practices (DFMEA) and change management (ECN/ECR)
• DFM/DFA and value engineering to meet cost, quality and serviceability targets
• Rapid prototyping, prototype build documentation and test method development.
• Supplier collaboration for material selection (metals, weldments, powered components) and manufacturability
• Use of PDM and ERP (e.g D365) for BOMs, revisions and configuration control.
• Creation of clear, visual work instructions in collaboration with Manufacturing Engineering.
• Ability to write standard operating procedures using company templates and structure.

Responsibilities

• Own the design and development of complete product systems such as welded/formed metal structures, mechanisms and power actuators, from concept through manufacturing transfer.
• Generate and maintain 3D models, 2D drawings, BOMs and specifications for full product designs.
• Lead NPI/NPD projects, driving design iteration, prototyping, verification and validation builds in collaboration with Quality and Manufacturing, Production, Purchasing and ERP administrators.
• Execute engineering changes (ECNs) and maintain configuration control through the QMS.
• Collaborate cross functionally (Manufacturing, Quality, Supply Chain, Service) to meet cost, quality and scheduled targets.
• Support design reviews and risk management (DFMEA) documenting decisions and tradeoffs.
• Provide on-site support during pilot, ramp and early production to resolve design issues quickly.
• Build and maintain Design History Files (DHF) and contribute to Device Master Records (DMR) in compliance with ISO 13485 and 21 CFR 820 design control requirements.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 11-50 employees