Product Development Engineer

Champion Healthcare Solutions•Ocala, FL

14d•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 full-product ownership of new Class I and Class II medical products, including upholstered assemblies, metal frames, mechanisms and power actuators. This role is specifically targeted to strengthen Champions upholstery and foam engineering expertise, while developing end to end New Product Introductions and New Product Development. The engineer will integrate upholstery design (Rhino8 to AccuMark) workflows, with large mechanical assemblies in SolidWorks, ensuring clinically effective and manufacturable solutions that meet FDA and ISO regulatory requirements.

Requirements

Bachelor’s degree in mechanical engineering, or equivalent experience to the mechanical engineering field is required.
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.
Expertise in upholstery engineering: foam construction, engineered textiles, seam allowances and pattern development. Rhino8 to AccuMark workflow for upholstery design integration
Full product CAD ownership including upholstered assemblies, frames and mechanisms in large assemblies.
Mechanism design for medical seating.
Structural analysis using Inventor/Nastran for seating frames and load-bearing components.
Design Controls within 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 (foams, textiles, metals) 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.

Responsibilities

Own the design and development of complete product systems such as upholstery, foam, welded/formed metal structures, mechanisms and power actuators, from concept through manufacturing transfer.
Develop upholstered assemblies including foam cushions, contouring, engineered textiles and patterning using Rhino8 and AccuMark.
Integrate upholstery designs into large CAD assemblies of chairs and procedure seating ensuring fit, comfort and manufacturability.
Generate and maintain 3D models, 2D drawings, BOMs and specifications for full chair designs.
Lead NPI/NPD projects, driving design iteration, prototyping, verification and validation builds in collaboration with Quality and Manufacturing.
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.