Job Title: Catheter Engineering Manager

Work Location: Massachusetts

Summary:

In this hands-on leadership position, the Catheter Engineering Manager will be responsible for the end-to-end lifecycle—including design, documentation, validation, and product lifecycle management—of a primary cardiac mapping device. This role requires a blend of direct technical execution and personnel management, necessitating deep collaboration with internal R&D, manufacturing, quality, and external supply chain partners.

This is a full-time, on-site role.

Responsibilities:

• Leadership & Compliance: Direct the catheter engineering unit under strict adherence to FDA Design Control protocols and serve as a champion for internal quality systems.
• External Management: Oversee and coordinate with third-party vendors and contract manufacturers to align on project milestones, technical deliverables, and delivery schedules.
• Reporting: Act as the primary technical point of contact for the executive team and project managers regarding the health and status of catheter-specific initiatives.
• Technical Documentation: Maintain full ownership of the Design History File (DHF) and Device Master Record (DMR), including the Traceability Matrix and DFMEA.
• Validation & Manufacturing: Partner with manufacturing partners to design and implement robust Verification & Validation (V&V) protocols, optimize production yields, and identify cost-reduction opportunities without sacrificing device integrity.
• Risk & Clinical Support: Collaborate with the Quality department on risk management files and provide necessary technical systems support for global clinical investigations.
• Standards Adherence: Guarantee that all hardware designs satisfy international benchmarks for safety, performance, and biocompatibility (including relevant ISO and CFR standards for sterile medical devices).
• Culture: Cultivate a transparent, high-performance environment focused on iterative improvement and patient-centric innovation.

Qualifications:

• Education: A Bachelor’s, Master’s, or Doctorate in Mechanical Engineering or a related technical field.
• Leadership: At least 2 years of experience managing technical teams within the medical device industry.
• Technical Tenure: 6+ years in medical device R&D, with a strong preference for those with specific experience in cardiac devices or Electrophysiology (EP).
• IP Strategy: Proven experience contributing to patent filings and intellectual property protection.
• Communication: Superior verbal and written skills, with the ability to convey complex technical concepts to non-technical stakeholders.
• Agility: The ability to thrive in a high-velocity startup environment while maintaining the discipline required for late-stage, process-heavy regulatory cycles.

Published Category: Manufacturing & Technical Operations