Systems Engineering Manager (Hybrid)

Your opportunity

By joining the Kardium team, you can help make a difference in the lives of millions around the world. Kardium is developing a ground breaking medical device for the minimally-invasive diagnosis and treatment of atrial fibrillation, a heart condition that can cause strokes, heart failure, and other heart-related complications.

Kardium has a fantastic technical team that has developed a product with strong, unique and customer-valued differentiators versus other solutions on the market: The Globe® Pulsed Field System. We have built connections with key opinion leaders who are already using the Globe System and are helping to tell our story.

What you’ll be doing

Your responsibilities will include:

• Management of the Systems Implementation, Usability, and Technical Publications teams, working closely with team leads and team members to ensure project schedules are met.
• Communication of high-level project milestones and regulatory submission schedules to your team, ensuring appropriate prioritization and clarity of larger systems engineering work-packages.
• Working closely with Regulatory Affairs, Clinical Engineering, Clinical Training, Risk Engineering, and Product Management, ensuring that product labeling, training, usability, product requirements, and risk management documentation is audit- and submission-ready.
• Identifying and prioritizing improvements to Design & Development documentation infrastructure in collaboration with the Application Development team.
• Ensuring that human factors and summative usability testing programs appropriately balance regulatory, risk, training, and business needs.

As a member of the Clinical and Systems Engineering Team, the Systems Engineering Manager will also perform other tasks, as needed, including:

• Defining long-term Design and Development infrastructure improvements, in collaboration with Regulatory Affairs and the Clinical and Systems Engineering Manager.
• Participation in Product Management roadmap meetings; prioritizing product improvements and underling resource management.
• Attending clinical and pre-clinical procedures, staying up to date with product usage, and ensuring that product improvement objectives align with user needs.
• Communicate experiments, analyses and results to teammates and senior leadership.

What you bring to the team

Our Kardium team is smart, creative, and passionate about creating cutting-edge medical devices to help improve people’s lives. We work within a collaborative environment based on trust and respect. And we understand that only by working together can we solve the unsolvable.

You are suited to our approach and possess these attributes:

Education and Experience

• Bachelor’s degree, preferably in a technical/science field, or equivalent combination of education and experience
• A minimum of five years experience in medical device design and development
• Experience in managing cross-functional engineering teams
• Strong working knowledge of ISO 13485 and FDA QSR or ISO 9001 in a regulated industry
• Experience with risk management, human factors engineering, clinical engineering, medical device product training, requirements management, and verification & validation testing

Skills

• Strong analytical skills and critical thinking
• Established track-record of successful team leadership; setting realistic and attainable goals, providing room for growth, and establishing a shared vision of team objectives
• Excellent written and verbal communication and technical documentation skills
• Ability to balance business needs, regulatory requirements, and project timelines
• Highly organized, detail-oriented, and conscientious
• Excellent interpersonal skills, with track-record of driving consensus with diverse stakeholders
• Willingness to travel occasionally

Why work at Kardium

A meaningful career working with a truly innovative technology and an ambitious team, combined with:

• Knowing every day that you are making a difference in people’s lives by helping treat a condition that debilitates millions worldwide
• A great working environment with opportunities to develop your skills and knowledge
• Opportunity to extend your knowledge by interacting with other team members in a multi-disciplinary environment that includes electrical and mechanical engineers, biologists, and specialists in human factors, and clinical and regulatory affairs
• An engaged leadership team who believes in mentoring and growing employees’ careers
• Supportive and fun colleagues with plenty of social events to encourage people connections
• And our employees think we are great too – check out Glassdoor to learn more!

Thanks in advance for your interest in Kardium!