Engineering Manager/Principal Engineer
New Yesterday
A growing medical device manufacturing client in Maple Grove, Minnesota is looking to hire a hands-on Engineering Manager! This will be playing a critical role in leading a dynamic team of engineers to design, develop, and innovate cardiovascular devices with a focus on heart valve technologies. This position requires a deep understanding of both the engineering principles and the medical aspects related to heart valve systems. We are looking for someone who has proven success driving product development, ensuring regulatory compliance, and fostering a culture of continuous improvement while leading by example. We are looking for someone who can not only work closely with marketing teams to understand customer needs and market trends, contributing to the development of product strategies but collaborate with Manufacturing teams to ensure seamless technology transfer and production scale-up. Duties of Role: Oversee the entire product development lifecycle for heart valves, from concept to commercialization.
Collaborate with cross-functional teams, including R&D, Quality Assurance, Regulatory Affairs, and Manufacturing, to ensure alignment with project goals and timelines.
Drive the development of novel heart valve technologies, considering both technical feasibility and clinical requirements.
Lead or mentor a multidisciplinary team of engineers, including mechanical and biomedical engineers.
Provide technical leadership and guidance to the engineering team, participating in design reviews and troubleshooting technical challenges.
Work closely with the Regulatory Affairs team to ensure all heart valve designs and developments comply with applicable regulatory standards and requirements.
Collaborate in the preparation of regulatory submissions
Collaborate with the Quality Assurance team to establish and maintain robust quality control processes for heart valve manufacturing.
Implement and oversee testing protocols to validate the performance and safety of heart valve products.
Must Haves: Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related field; advanced degree (Master's or Ph.D.) preferred.
10 + years of experience in in medical device product development, with a focus on heart valves or cardiovascular devices.
Strong leadership skills and experience managing cross-functional engineering teams.
In-depth knowledge of relevant regulatory standards (FDA, ISO, etc.) and experience with regulatory submissions.
Excellent communication skills with the ability to interact effectively with internal teams, external partners, and regulatory authorities.
Salary of $120,000 to $160,000 + bonus
- Location:
- Maple Grove
- Category:
- Engineering