To support and provide direction/guidance to the design engineering group as well as participate in new product introduction to ensure new and existing design meets manufacturing standards and cababilities. Participate and provide expertise and sign off on design for manufacturing. Provide guidance and re-design for legacy product improvements Class 1 & II medical devices. Recognized as technical leader and resource for advanced manufacturing.
Essential Duties and Responsibilities:
Expert in CAD (SolidWorks preferred) and experience with tools consistent with mechanical engineering experts.
Leader in design for quality using risk management tools and lean product development approaches.
Tooling/Fixture design for new and existing products that meet operations requirements.
Designs components or functional systems, and modifies existing designs to develop or improve products and facilitate manufacturing operations and higher yield rates.
Leader in design for manufacturability through coordination with suppliers and internal team members.
Provides guidance and expertise in DFMAS (Design for Manufacturing Assembly and Service) at conceptual stage of new product design.
Works with manufacturing, service and specialists to understand customer needs for products and process improvements on existing products.
Leads design development and optimization through prototyping, modeling, simulation and analysis of existing designs.
Provides expert consultation in one or more areas of design, development, and implementation of technical products or systems.
Recommends alterations to development and design to improve quality of products and/or procedures.
Determines and develops test requirements for components, assemblies and systems as required; supports Verification and Validation testing.
Supports development of budgets and timelines for projects.
Provides consultation and collaboration with various Engineering groups in one or more areas of design/re-design, development, process improvement, implementation of technical products or systems.
Supports maintenance of design history file for assigned projects, adhering to Arthrex design control procedures.
Administer and expedite the Design Control Process, DHF management, Design Change Process, Design Verification and Validation in compliance with the QMS and in support of product releases.
Provides Regulatory department technical support for assigned projects as needed.
Supports Marketing and Product Management with technical information to be used for training and marketing of assigned products.
Reports progress and status of assigned projects on a timely basis.
Some required domestic travel to attend trade shows and visit established accounts as well as prospective accounts. International travel may be required.
Serve as the lead on exisiting supplier base to assist in design/process improvements.
Manage projects in project management tool.
The above statements describe the general nature and level of work being performed in this job. They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management.
Education and Experience:
Bachelor’s Degree in Mechanical Engineering required.
MS degree preferred.
Minimum of 7 years of experience required; preferably in a medical device company.
Knowledge and Skill Requirements/Specialized Courses and/or Training:
Demonstrable experience with product development from concept and testing to production release
Expert understanding of electro-Mechanical and electro-Optical design principals.
Expert in 3D-CAD (e.g. SolidWorks).
Expert in geometric dimensioning and tolerancing (GD&T), and analysis of tolerance stackup for complex assemblies.
Experience with design optimization and simulation.
Demonstrable experience in Design for Manufacturability Assembly and Serviceability, including manufacturing process optimization support, and Design for Cost.
Expert understanding of fabrication techniques (e.g. machining, molding, laser cutting, etc.) and associated design tradeoffs.
Technical knowledge in development methodologies, design, and project implementation.
Demonstrable experience in Design for Quality with tools.
Knowledgeable of Six Sigma and Analysis preferred.
Green Belt or Black Belt preferred.
Knowledgeable of FDA and ISO guidelines for the development of medical devices preferred.
Project management skills and training preferred.
Strong communication skills and accountability to project deliverable timing and budgets required.
Machine, Tools, and/or Equipment Skills:
Working knowledge of mechanical testing equipment, electronic testing equipment, automated test equipment, SolidWorks or other 3D modeling software required.
All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.