Lead Research & Development Engineer, Vascular

Cook Medical; West Lafayette (IN); On-site; USD 90,000 - 120,000; Full time

Job summary

Cook Medical in West Lafayette, IN is seeking an experienced leader to oversee a team of engineers in developing new medical device designs. The role focuses on project leadership and technical guidance, ensuring collaboration across various departments while managing project milestones successfully.

The ideal candidate will possess a relevant degree and significant experience in the medical device industry, demonstrating strong leadership skills and fluency in AI concepts. This opportunity involves mentorship and compliance within regulatory standards.

Qualifications

• 7 years relevant experience with a Bachelor’s degree, 5 years with a Master’s, or 4 years with a PhD.
• Experience in Product Development projects in the Medical Device industry.
• Proven ability to mentor and lead project teams.

Responsibilities

• Lead project teams for medium to large-scale R&D projects.
• Drive improvement initiatives and manage project tasks.
• Represent Cook in industry standards and conferences.

Skills

Project management methodology and skills

Proven technical leadership

Knowledge of medical device quality standards

Fluency in Artificial Intelligence (AI)

Education

Bachelor’s degree in engineering or related field

Master’s degree

PhD

Job description

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 large-scale 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 Cook's behalf in industry conferences.
• 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.
• 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.
• 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.