Overview

This role will be responsible for leading a team of engineers focused on research, development, and implementation in the Interventional Therapies new product development pipeline. Responsible for technical leadership and contribution within the project team which could include signing off on deliverables and supporting the training and delegation of work responsibilities to other engineers on the team. This role will not have direct HR employee responsibilities. Project areas of focus may include development of Drainage Catheters, Sheaths, Needles as well as other vascular projects.

Responsibilities

• Lead project teams and provide technical leadership for medium to largescale R&D projects, collaborate to provide technical leadership across the department and/or multiple projects in a specific area.
• Responsible for approval of work product or work for project teams.
• Manage the activities of the project team and drive project tasks to ensure timely completion of project milestones and business metrics are achieved in collaboration with project manager (when one is assigned).
• Work closely to build effective relationships with cross functional groups to achieve project and company goals.
• As part of project/technical leadership, responsible for:
  • Leading technical development of projects.
  • Leading all key design decisions to ensure quality of design selection to meet customer needs.
  • Retrospective project reviews to understand lessons learned.
  • Managing device evaluations and compliance with Quality, Regulatory and company policies and systems.
  • Project budget tracking and management
• May attend industry specific working groups and industry conferences.
• Must have launched multiple 510K products.
• Act as a mentor to other personnel in the department

Qualifications

• Bachelor's degree in Engineering or a related field required and 15 years' of relevant experience OR• Master's degree and 12 years' relevant experience OR• PhD and 10 years' relevant experience

Qualification Requirements:

• Expereinced in Product Development projects within the Medical Device industry
• Proven project/technical leadership
• Project management methodology and skills
• Proven experience working closely with project managers
• Knowledge of medical device quality standards ISO13485/FDA practices, EUMDR, GMP and similar regulated industry standards

Physical Requirements:

• Works under general office environmental conditions.
• Sitting for extended periods, utilizes close visual acuity for working with computers, etc.
• Personal protective equipment including safety glasses, lab coat and gloves required in many areas associated with this position