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Manager - R&D

Job Code - EC0876

HEAD OF R&D AND NEW PRODUCTS INTRODUCTION – Medical Components – Ft. Lauderdale
Reports to: VP Medical Business
R&D and Business Development Engineering

Our client is a global supplier of custom solutions. The diverse, world-wide customer base includes automotive, telecom, industrial, consumer electronics, and Medical Life Science, including medical device components to finished sterile devices.

This position is part of a centralized Medical Business Unit Team that is focused on Medical Device Development and Manufacturing. This role will manage the site P&L, support business development by providing technical expertise in medical devices and drafting of proposals, leads engineering team to provide design and manufacturing solutions to meet customer requirements, and ensures the highest standards of Quality requirements are maintained. The successful candidate will be comfortable leading the site, presenting to large groups (internal and external), supporting Business Development, leading Product Development engineering and Manufacturing engineering teams as an overall rounded leader with responsibilities in all product life-cycle phases.
This position requires engineering management experience in a highly regulated environment such as medical, automotive or military along with experience in electromechanical assemblies. The emphasis of this position will be on the Engineering Management, business development, product development, and sustaining engineering of medical devices, both driven by internal specifications as well as external customer requirements including R&D, design, development, testing and project management

Responsibilities

• Manages product development team based on Customer Specification or Internal Marketing Initiatives
• Manage R&D teams in the development of new customer and internal projects
• Manage Manufacturing engineering in the development of new processes and improvement of existing processes
• Manages the Engineering NPI (New Product Integration) process, through to production

• Assist Business Development & Sales by gathering/defining customer requirements, and writing proposals
• Creation of cost models for engineering programs and device manufacturing
• Identify and make recommendations for capital investments for site
• Interface directly with customers to resolve technical matters dealing with proposal generation and business
• Turn Concepts into product designs, creating and maintaining the product throughout the product lifecycle
• Manage all Engineering activities internally and liaise with the Global Engineering teams to support NPI and sustained projects.
• Manage the performance and growth of direct reports
• Oversee the development of prototyping and test plans to support concept, design, pilot and production validation phases
• Guide customers through the product development process and general regulatory requirements to gain market clearance
• Manages and leads team in the outline/creation of design inputs/outputs, design verification & validation plans/protocols process validation plans/protocols, test methodologies, , test reports
• Manage and support sustaining engineering activities
• Ensures compliance and progression of the QMS under applicable standards

Requirements:

• Minimum 10 years’ experience in Product Development in a regulated environment (Medical Preferred)
• Minimum 5 years’ Experience leading engineering teams
• BS degree in engineering discipline
• Minimum 5 years’ management experience
• Minimum 5 years’ experience in Medical Device or Catheter
• Strong understanding of 3D CAD systems (SolidWorks preferred) and reading drawings
• Strong problem solving and analytical skills
• Minimum 5 years’ experience in Project Management
• Experience with Microsoft Office suite: Word, Excel, PowerPoint, Project
• Experience in supplier management
• Strong business acumen
• Experience with customer relations and business development
• Minimum 5 years’ experience under ISO 13485 compliant QMS

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