Overview
This role will lead a team of engineers focused on research, development, and implementation of new medical device designs. This role will be responsible for technical leadership 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 employee responsibilities.
Responsibilities
Lead project teams or 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 or subject matter expertise;
Drive improvement initiatives in area of expertise, which may include process ownership for department;
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;
May represent Cook in industry standards, working groups and present on Cooks behalf in industry conferences; and
Act as a mentor to other personnel in the department.
Qualifications
Bachelor's degree in engineering or related field required and 7 years' relevant experience OR;
Master's Degree and 5 years' relevant experience OR;
PhD and 4 years' relevant experience;
Experience in Product Development projects within Medical Device or regulated industry/adjacent experience
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;
This role requires fluency in Artificial Intelligence (AI) and data concepts, including the ability to critically evaluate AI outputs, improve workflows using approved tools, identify and mitigate bias or inaccuracies, and communicate AI-driven insights clearly and responsibly to peers and managers; and
Qualified candidates must be legally authorized in the United States. Cook does not intend to provide sponsorship for employment visa status' for this employment position.