Sr Project Manager/Engineer
Job description
CardioFocus is seeking a full-time Sr Project Manager/Engineer to join our team in Marlborough, MA.
In this role, you will support the research and development team, consultants, and contract
design/manufacturing companies to ensure our medical devices and equipment software are designed and developed on time, within budget and according to company procedures.
Lead weekly project tactical meetings to ensure weekly tasks are planned and coordinated.
Work with project teams to create and maintain development plans for projects from conception through commercialization.
Collaborate with the project team to define project objectives, requirements, and assumptions necessary to structure a project or activity.
Coordinate and track external development, testing, and production vendor timelines.
Work with Quality, Clinical and Regulatory personnel to support regulatory submissions.
Ensure all design and development activities adhere to regulatory requirements (e.g., FDA, CE, MDR).
Maintain detailed, accurate documentation throughout the product lifecycle.
Qualifications
Excellent communication and team management skills, capable of driving cross-functional, global teams.
Ability to effectively manage scope changes and perform impact assessments.
Strong organizational skills with attention to detail, especially for regulatory compliance documentation.
Effective leadership, interpersonal and communication skills.
Ability to work and contribute effectively in a team environment helping the team identify dependencies and resolve constraints.
Ability to adapt quickly in a fast-paced, evolving company and operate with a high sense of urgency
Additional Information
Business travel of up to 15% may be required.
CardioFocus is an Affirmative Action and Equal Opportunity Employer. We value diversity and are committed to creating an inclusive environment for all employees.
Please submit your resume and cover letter to: careers@cardiofocus.com