Project Manager, Manufacturing Engineer, Biomedical Engineer

Job Title:

Project Manager

Job Description

The Project Manager will lead the development of an electrode mapping catheter system from concept through clinical readiness. This role involves seamless execution across R&D, quality, regulatory, and manufacturing functions, requiring deep familiarity with catheter-based medical devices, early-phase development, design controls, and cross-functional leadership.

Responsibilities

+ Lead day-to-day execution of the electrode mapping catheter development program, covering concept, design, feasibility, verification, validation, and clinical build support.

+ Develop and maintain detailed project schedules, Gantt charts, dashboards, and milestone trackers.

+ Facilitate core-team meetings, design reviews, and phase-gate checkpoints, ensuring alignment with design control requirements.

+ Partner with R&D engineers to coordinate activities related to catheter shaft design, distal assembly, pull-wire systems, electrode mapping features, and integration of flexible circuit technologies.

+ Ensure documentation readiness, including DHF elements, test protocols, verification plans, risk analyses, and manufacturing process documentation.

+ Work closely with Quality, Regulatory, Clinical, Operations, and Manufacturing Engineering teams to ensure readiness for pre-clinical and clinical builds.

+ Coordinate design transfer activities and ensure early alignment with manufacturing strategy.

+ Maintain and update the risk register, ensuring the team identifies, mitigates, and tracks technical and programmatic risks.

+ Support regulatory milestones by ensuring project deliverables meet FDA, EU MDR, and IEC expectations.

+ Lead communication and coordination with suppliers and external partners involved in catheter components, materials, and testing.

+ Present project updates, risk status, and key decisions to leadership using clear, data-driven communication.

Essential Skills

+ 5+ years experience in medical device development as a Project Manager or Senior Engineer, ideally with catheter-based systems.

+ Demonstrated experience managing projects through early-phase R&D, feasibility builds, and design control.

+ Strong technical understanding of catheters, including electrode mapping or electrophysiology systems, multi-lumen extrusion, pull-wire mechanisms, braided shafts, flexible circuitry, and distal assembly design considerations.

+

Experience with FDA submission support, verification/validation planning, and clinical build coordination.

Additional

Skills & Qualifications

+

Experience with mapping catheters, EP catheters, or electro-anatomical systems.

+ PMP certification.

+ Proficiency in PM tools such as Smartsheet, MS Project, or Windchill PLM.

+ Engineering degree in Mechanical, Biomedical, Electrical, or related field.

Work Environment

The work environment is dynamic and collaborative, involving cross-functional interaction with various teams. Employees utilize advanced project management tools and are engaged in a detailed-oriented and regulatory-compliant setting, focusing on medical device development. The dress code is professional, reflecting the high standards of the medical device industry.

Job Type & Location

This is a Contract to Hire position based out of Minneapolis, MN.

Pay and Benefits

The pay range for this position is $57.00 - $67.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

- Medical, dental & vision - Critical Illness, Accident, and Hospital - 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available - Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability - Health Spending Account (HSA) - Transportation benefits - Employee Assistance Program - Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Minneapolis,MN.

Final date to receive applications

This position is anticipated to close on Jan 23, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a…