Project Manager (Medical Devices) at Qapel Medical LLC – Fremont, California

Position Title: Project Manager Job Location: 4245 Technology Drive, Fremont, CA (Onsite)

Department: Project Management Worker Category: Full-Time/Exempt

Industry: Neurovsacular Medical Devices

About Q’Apel:

At Q’Apel, we’re redefining neurovascular access with breakthrough technology that meets clinicians in their most critical moments, when seconds count. We develop and deliver cutting-edge Neurovascular Intervention Devices that solve real-world challenges in vascular intervention. Our fast-paced, high-growth environment thrives on innovation, collaboration, and bold thinking. Every team member here plays a vital role in transforming patient care and shaping the future of neurovascular treatment.

If you’re passionate about technology that saves lives, and want your work to make a real difference, this is your team.

Who We Want:

We're looking for a Project Manager to drive implementation and completion of New Product Introduction (NPI), Product Line Extensions, Product Lifecycle Management (PLM) and Manufacturing Improvement activities.

You’ll be a key technical leader, working at the intersection of R&D, Quality, Regulatory and Production to ensure key initiatives are efficiently executed.

This is more than just a job; it's a chance to build something meaningful. You’ll bring products from concept to commercial scale, helping accelerate time-to-market while upholding world-class quality standards.

What You’ll Work On:

• Leads projects and project teams; Creates project plans with team members; Supervises team members to meet project goals and deadlines.
• Ensures product documentation is in accordance with Quality Management System.
• Provides engineering testing and documentation that complies with regulatory requirements.
• Updates product specifications, risk management files, test protocols and reports, trace matrices and design history file in accordance with the Quality Management System.
• Coordinates and manages design control activities with external suppliers.
• Works cross functionally with department heads to formulate strategies or project proposals.
• Spearheads design transfer activities, ensuring seamless handoff from R&D to production.
• Develops and executes protocols for design verification/validation, and process qualification.
• Troubleshoots complex manufacturing issues and implements data-driven solutions using Six Sigma and root cause analysis tools.
• Authors and maintains documentation that meets FDA and global regulatory requirements.

What You Bring:

Education & Background

• Bachelor’s degree in engineering (master’s degree preferred) or related field (or equivalent technical experience).
• 10+ years of experience in Program Management as well as medical device design, development and/or manufacturing engineering, ideally in neurovascular or catheter-based technologies.

Technical Skills

• Expertise in design controls, Design Verification/Validation, Risk Management, process development, and documentation within a regulated environment.
• Familiarity with EtO Sterilization and ISO 10993-1, Biological Evaluation of Medical Devices.
• Deep understanding of FDA regulations, ISO 13485, MDD/MDR, and global QMS standards.
• Skilled in CAD software (SolidWorks preferred), statistical process control, DOE, and Six Sigma tools.

Leadership & Execution

• Track record of leading cross-functional projects from concept through commercialization
• Strong verbal/written communicator with the ability to influence across all levels
• Agile problem-solver who thrives under pressure in dynamic environments
• Willingness to travel periodically to suppliers, partners, and contract manufacturers

Our salary ranges are calculated by role and level. Your position within that range will be determined by your job-related knowledge, skills, experience, relevant education, and training/certifications. In addition to those factors, we also examine internal equity as well as consider the current market rate, and the title may be assessed one level lower or higher accordingly. After you join the company, your performance, contributions, and results along with business and organizational needs, will affect your base salary. The base salary range for this full-time position is between $150,000 to $200,000 + equity + benefits.

This document contains confidential, proprietary information of Q’Apel Medical, Inc. It may not be copied or reproduced without prior written permission from Q’Apel Medical, Inc