Product Development Engineer

Introduction

The Product Development engineer is responsible for the design support, refinement, and release of mechanical and electromechanical components and assemblies used in 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.

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

Candidate Qualifications:

• 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.
• 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.