Principal Engineer, R&D

Job Type

Full-time

Description

ABOUT 4C MEDICAL TECHNOLOGIES:

We are a small but mighty, well-financed team dedicated to proving the effectiveness of our innovative, life-enhancing, lifesaving therapy. 4C Medical Technologies, Inc., located in Maple Grove, MN, is pioneering the next generation of transcatheter mitral valve replacement (TMVR) technology. Our Alta Valve is currently in the clinical trial phase of FDA approval.

Joining our team presents a unique opportunity to make a significant impact on the development of life-saving medical devices as well as the opportunity to learn, grow and make significant contributions in a dynamic, collaborative, fast-paced environment. If you are passionate about innovation, teamwork, and improving patient outcomes, we invite you to apply.

JOB SUMMARY:

Specializing in Heart Valves, you will play 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. The successful candidate will drive product development, ensure regulatory compliance, and foster a culture of continuous improvement.

KEY RESPONSIBILITIES:

Team Leadership:

Lead or mentor a multidisciplinary team of engineers, including mechanical and biomedical engineers.

Foster a collaborative and innovative team culture, encouraging open communication and knowledge sharing.

Provide guidance and support to team members, promoting their professional development. Product Development:

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. Technical Expertise:

Experience with Nitinol including design, manufacturing and testing.

Maintain a deep understanding of the latest advancements in heart valve technologies, cardiovascular physiology, and relevant medical device regulations.

Provide technical leadership and guidance to the engineering team, participating in design reviews and troubleshooting technical challenges. Regulatory Compliance:

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 Project Management:

Develop and manage project plans, ensuring that milestones and deadlines are met.

Identify and mitigate risks associated with project timelines and deliverables.

Communicate progress and challenges effectively to senior management and relevant stakeholders. Quality Assurance:

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. Cross-functional Collaboration:

Work closely with marketing teams to understand customer needs and market trends, contributing to the development of product strategies.

Collaborate with Manufacturing teams to ensure seamless technology transfer and production scale-up. Requirements

Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related field; advanced degree (Master's or Ph.D.) preferred.

Proven experience (10 years) 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 Description

$100,000 to $160,000 DOQ