Program Manager Contract

2 days ago

Santa Clara, United States Stealth Health Tech startup Full time

Job Overview

We are seeking a highly organized and detail-oriented Project Engineer to join our team in developing advanced catheter-based medical devices that integrate with energy-based therapeutic systems. This role combines engineering knowledge with basic project management tasks, ensuring all technical documentation, testing, and regulatory compliance activities are completed on time and meet industry standards. The ideal candidate will have relevant experience in the medical device industry, with a strong understanding of FDA and EU regulations, and proficiency in project scheduling and documentation management.


This role involves managing documentation, creating and maintaining project schedules, coordinating cross-functional activities, and ensuring compliance with regulatory requirements.


Key Responsibilities

Project Management

  • Develop, manage, and update detailed project schedules to track milestones, deliverables, and timelines using tools like Microsoft Project or similar software.
  • Coordinate and communicate with cross-functional teams (e.g., regulatory, quality, engineering) to ensure project timelines are met.
  • Assist the Senior Program Manager in reporting project progress and risks to senior management and other key stakeholders.
  • Facilitate team meetings and document meeting minutes.
  • Track project progress and ensure milestones are met.

Project Coordination

  • Assist in planning and designing project workflows.
  • Coordinate with internal teams (e.g., R&D, quality, and manufacturing) and external stakeholders on open action items and deliverables.

Documentation & Compliance

  • Author and update key project documents, including Design History Files (DHFs), requirements documents, protocols, risk assessments, and technical reports.
  • Ensure all documentation complies with FDA, ISO 13485, and EU Medical Device Regulations (MDR).
  • Maintain and manage Design Inputs and Outputs, Design Verification and Validation protocols, reports, and traceability matrices.
  • Maintain accurate project documentation, including timelines, budgets, and reports.
  • Support the preparation of regulatory submissions and audits.

Regulatory Support

  • Assist in the preparation of technical documentation for FDA 510(k) submissions and EU CE Mark filings.
  • Ensure all project activities adhere to regulatory requirements and internal quality system processes.

Communication & Reporting

  • Act as a liaison between project teams and senior management.
  • Prepare and present project status updates to stakeholders.

Risk and Change Management

  • Identify potential project risks and propose mitigation strategies.
  • Assist in managing changes to project scope, schedule, and resources.


Qualifications

Education

  • Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, or a related field.
  • Bachelor’s degree in business, engineering, life sciences, or a related field is also acceptable.

Experience

  • Minimum 3 years of experience in a medical device engineering or project planning role.
  • 1-3 years in project management, preferably in the medical device or healthcare industry.
  • Familiarity with regulatory requirements for medical devices (FDA 21 CFR 820, ISO 13485, EU MDR) and Design Control principles.
  • Experience managing and maintaining project schedules and technical documentation in a regulated industry.
  • Experience in coordinating activities with a cross-functional team

Skills and Competencies

  • Strong proficiency with Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).
  • Experience using Microsoft Project (or equivalent project management tools) for scheduling and timeline management.
  • Familiarity with document management systems (e.g., MasterControl, Grand Avenue Software, Windchill, Agile, etc.) for handling design history files and other regulated documentation.
  • Familiarity with medical device regulations (e.g., FDA, ISO 13485).
  • Excellent written and verbal communication skills, with the ability to write clear and concise technical documents, protocols, and reports.
  • Strong organizational skills and attention to detail, with the ability to manage multiple priorities in a fast-paced environment.
  • Strong problem-solving abilities and a proactive approach to addressing challenges and meeting deadlines.

Preferred Qualifications

  • Previous experience working with catheter-based medical devices or similar minimally invasive technologies.
  • Associate in Project Management (CAPM) or Project Management Professional (PMP) experience is a plus.


Why Join Us?

  • Be a key contributor to the development of life-saving medical technologies.
  • Collaborate with a talented, multidisciplinary team in a highly innovative and regulated environment.

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