Medical Device PM/Engineer — R&D & Regulatory Lead

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, 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.