Engineering Project Manager
INC- Naples, FL
Responsible for full life cycle development of Class I and II medical devices, which includes initiation, design, development, execution, verification/validation, release, and product maintenance.
ESSENTIAL DUTIES AND RESPONSIBILITIES: Using lean techniques and tools, manage complete life cycle of critical projects from concept through production release and post market surveillance. Lead cross-functional, matrixed teams to complete project milestones on-time, on-budget, and meeting the requirements of the Arthrex Quality Management System. Drive work in a lean environment, smartly handle inter-dependencies between teams, and identify and manage technical, project, and timeline risks. Ensure transparency, enforce accountability and strive to achieve predictability within project teams and to executive management. Manage Design History deliverables for assigned projects, adhering to Arthrex design control procedures. Provides Regulatory department technical support for assigned projects as needed Support architects and designers of functional systems as required. Collaborate with Product Managers to clarify product success and the “definition of done”. Recommend alterations to development and design to improve quality of products and/or procedures. Ensure alignment of internal and external customers. Supports surgeon and distributor customers by training and/or educating on technical aspects of assigned products as needed. Some required travel to attend trade shows and visit established accounts as well as prospective accounts. International travel may be required.
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 Engineering required. Preferably in Biomedical, Electrical or Mechanical Engineering.3 years experience in product development environment required, preferably in medical device.
Knowledge and Skill Requirements/Specialized Courses and/or Training:
- Expert project management skills; experience with lean product development preferred.
- Demonstrable experience with medical device product development from concept and testing to production release
- Strong strategic thinker, excellent collaboration and communication skills, careful attention to detail
- Ability to balance business and technical risks while remaining compliant with internal systems.
- Working knowledge of medical device regulations and associated quality systems, particularly design controls and risk management.
- Understanding of electro-Mechanical design principals.
- Understanding of Design for Manufacturability, including manufacturing process optimization support, and Design for Cost.
- Understanding of Design for Quality with tools such as FTA, FMEA, HALT/HASS.
- Manufacturing process knowledge preferred.
- Awareness orthopedic surgery principles, theories, and products preferred
- Knowledgeable of FDA and ISO guidelines for the development of medical devices required.
- Strong communication skills and accountability to project deliverable timing and budgets required.
- Ability to confidently lead complex, cross functional teams independently
- Demonstrable bias for action
- Strong desire and proven ability to learn quickly
- Continuously seeking ways to improve complex systems of people and process, while eliminating waste
Machine, Tools, and/or Equipment Skills:
Experience with Medical Capital Equipment development and testing. Understanding of electrical design standards.
Knowledge of surgical equipment and instrumentation, mechanical testing equipment, PC, ProEngineer or other 3D modeling software.
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.
Location/Region: Naples, FL (US)