ENGINEERING PROJECT MANAGER - FL
A well-established orthopedic medical device manufacturer in southwest Florida is seeking an Engineering Project Manager. The ideal candidate will be a strategic thinker who pays careful attention to detail, has excellent collaboration abilities and strong written and interpersonal communication skills. The Engineering Project Manager is 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:
- Manage complete life cycle of critical projects from concept through production release and post market surveillance, utilizing lean techniques and tools
- Lead cross-functional, matrixed teams to complete project milestones on-time, on-budget, and meeting the requirements of the Quality Management System.
- Identify and manage technical, project, and timeline risks.
- Ensure transparency and enforce accountability within project teams
- Manage Design History deliverables for assigned projects, adhering to the company’s design control procedures.
- Provides Regulatory department technical support for assigned projects
- Support architects and designers of functional systems
- 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
- Some required travel: trade shows, established accounts, prospective accounts.
- International travel may be required.
EDUCATION AND EXPERIENCE:
- Bachelor’s degree in Engineering : Biomedical, Electrical or Mechanical Engineering
- 3 years of experience in product development environment in medical device.
- 5-10 years of Lean or Agile Project Management experience
KNOWLEDGE AND SKILLS:
- Understanding of electro-Mechanical design principals.
- Design for Manufacturability: manufacturing process optimization support and Design for Cost.
- Understanding of Design for Quality with tools such as FTA, FMEA, HALT/HASS.
- Familiar with orthopedic surgery principles, theories, and products
- Knowledgeable of FDA and ISO guidelines for the development of medical devices.
- Development and testing of Medical Capital Equipment
- Knowledge of surgical equipment and instrumentation, mechanical testing equipment, PC, ProEngineer or other 3D modeling software.