Clear Dynamic is revloutioninzing pain management through glass microsphere technology. Our proprietary, water-soluble embolic particles provide targeted treatments for paitents. Developed using advanced materials engineering, our microspheres are designed to safely dissolve in the body, providing a precise and innovative approach to pain intervention. We are a passionate team, dedicated to improving patient outcomes through groundbreaking materials science. Join us as we shape the future of interventional medicine.

About the Opportunity

As a Senior Product Quality Specialist, you will serve as a key cross-functional contributor to ClearDynamic's medical device product development efforts, supporting projects from early concept through commercialization. You will lead quality engineering initiatives throughout the development lifecycle, ensuring product safety, design robustness, and compliance with FDA Quality System Regulations, ISO 13485, and other applicable standards.

Key Responsibilities

• Provide quality and compliance input for project decisions and deliverables and ensuring product designs meet regulatory and clinical safety requirements.
• Drive implementation and continuous improvement of risk management processes; contribute to the product Hazard Analysis and overall Risk Management File.
• Collaborate with cross-functional design team to support creation and documentation of Risk Management documentation (e.g. Hazard Analysis, dFMEAs, pFMEAs, etc.).
• Develop, update, and maintain Design History File and support Design Input / Output documentation (Product Specification, Component Specifications, and Prints).
• Evaluate predicate and competitor products for prior risk events or quality issues (e.g. from MAUDE databases, internal complaint records, and relevant scientific literature), feeding learnings into design requirements and risk management.
• Participate in design review activities to ensure compliance with internal/external requirements.
• Support the planning and documentation of biocompatibility strategies per ISO 10993, including Biological Evaluation Plans and Reports, in partnership with toxicologists and testing labs.
• Review and support verification, validation, and usability planning and documentation, ensuring risk management and usability inputs are translated into verification test plans, traceability, and compliance.
• Collaborate with internal teams to validate user needs through healthcare professional (HCP) interactions and design feedback loops; contribute to early clinical evaluations and first-in-human use assessments when applicable.
• Participate in or support regulatory submissions, including preparation and quality review of design and risk documentation for notified bodies and FDA.
• Actively participate in the change process to ensure the proposed changes to the products are systemically and thoroughly analyzed and assessed.
• Interface with Manufacturing, Operations, and Suppliers for evaluation of product designs for manufacturability, reliability, and cost-effectiveness, to ensure supplier quality and support effective design transfer, component qualification, and process controls.
• Apply systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues, with guidance/collaboration of the team.
• Recommend improvements to quality systems, processes, and product risk mitigations.
• Champion communication of quality goals, initiatives, and metrics within project teams and quality leadership, ensuring alignment with site and company-wide objectives.
• Develop quality processes required to support product development activities, as needed.
• Support internal and external audits and act as a subject matter expert for design and risk files.

About You

We would love to hear from you if you have the following:

• Bachelor's degree in Engineering, Biomedical Engineering, or a related technical field, or equivalent experience.
• 3-7 years of experience in medical device product development, quality engineering, or a regulated environment.
• Experience with bioactive glass technologies, absorbable medical devices, and/or medical device manufacturing (including materials characterization) is strongly preferred.
• Prior experience supporting or participating in FDA interactions (e.g., pre-submissions, audits, or design-related reviews) is strongly preferred.
• Working knowledge of ISO 13485, 21 CFR Part 820, ISO 14971, and ISO 10993.
• Proficiency with risk management tools and methodologies (e.g., FMEA, Hazard Analysis).
• Strong verbal and written communication skills; demonstrated ability to collaborate in cross-functional, matrixed environments.
• Familiarity with verification, validation, and usability testing practices.

Work With Us!

At Clear Dynamic, you'll be part of a team that's transforming lives through innovation.

Here's what you can expect when you join us:

Co-paid Health, Dental, and Vision Insurance
We offer comprehensive coverage to support your health and well-being.

Generous Paid Time Off & Holidays
We value work-life balance and encourage time to recharge.

Professional Development Support
Whether it's a course, certification, or conference, we offer reimbursement for training and growth opportunities.

Once You've Applied

Thank you for your interest in this position. Only those applicants selected for an interview will be contacted.