Project Manager/Engineer

CardioFocus, Inc.; Marlborough (MA); On-site; USD 110,000 - 160,000; Full time

Job summary

CardioFocus, Inc. in Marlborough, MA is seeking a full-time Project Manager/Engineer to support the R&D team and external vendors.

You will ensure medical device and software development aligns with budget, schedule and regulatory requirements. The role emphasizes leading cross-functional teams, maintaining development plans from concept to commercialization, and coordinating with QA, regulatory, and manufacturing partners to meet device standards.

Qualifications

• Bachelor’s degree in an Engineering or Scientific related field (Master’s preferred).
• 5+ years of experience in the medical device industry.
• Experience managing hardware and software development projects, including requirements gathering, design, development, testing, and integration.
• Intimate knowledge of medical device regulations (FDA, ISO 13485, IEC 62304, MDR) and design control processes.
• Strong understanding of critical chain project management principles, including buffer management.
• Experience creating and managing project plans with critical chain project management tools, preferred.
• Experience managing 2-3 programs concurrently, preferred.

Responsibilities

• 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.
• Support preclinical studies including planning, preparation, and execution.
• Work with Quality, Clinical and Regulatory personnel to support regulatory submissions.
• Ensure all design and development activities adhere to regulatory requirements (FDA, ISO 13485, IEC 62304, MDR).
• Maintain detailed, accurate documentation throughout the product lifecycle.

Skills

Communication

Team management

Regulatory documentation

Cross-functional collaboration

Leadership

Urgency and prioritization

Regulatory knowledge

Education

Bachelor’s degree in Engineering or Science

Master’s degree preferred

Tools

Critical chain PM tools

Job description

CardioFocus, based in Marlborough, MA, is a medical device innovator dedicated to advancing ablation treatments for cardiac disorders like atrial fibrillation. Our CE Marked CENTAURI System has treated over 5,000 patients globally, setting a new standard in AFib ablation by integrating Pulsed Field Ablation with the most widely used electrophysiology platforms.

CardioFocus is seeking a full-time 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.

KEY RESPONSIBILITIES

• 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.
• Support preclinical studies including planning, preparation, and execution.
• Work with Quality, Clinical and Regulatory personnel to support regulatory submissions.
• Ensure all design and development activities adhere to regulatory requirements (e.g., FDA, ISO 13485, IEC 62304, MDR).
• Maintain detailed, accurate documentation throughout the product lifecycle.

Minimum Qualifications

• Bachelor’s degree in an Engineering or Scientific related field (Master’s preferred).
• 5+ years of experience in the medical device industry required.
• Experience required managing hardware and software development projects, including requirements gathering, design, development, testing, and integration.
• Intimate knowledge of medical device regulations (e.g., FDA, ISO 13485, IEC 62304, MDR) and design control processes.
• Strong understanding of critical chain project management principles, including buffer management.
• Experience creating and managing project plans with critical chain project management tools, preferred.
• Experience managing 2-3 programs concurrently, preferred.

SKILLS

• 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.

We do not accept unsolicited resumes from recruiters or employment agencies. Any unsolicited resumes received will be considered the property of CardioFocus, Inc., and we will not be obligated to pay any referral fee unless a prior written agreement is in place.