This position provides Quality Engineering expertise and leadership in the application of Design Controls, Risk Management, and Quality System requirements throughout the product development lifecycle. The Senior Quality Engineer partners with Engineering, Product Management, Clinical, Regulatory Affairs, Project Management, and other Quality functions to support new product development, design changes to commercial products, and successful product commercialization in compliance with internal procedures and global medical device regulations. This role serves as a key Design Assurance resource, driving quality-focused decision making across cross-functional teams while ensuring design documentation is complete, compliant, and inspection-ready. The position requires the ability to work independently, adapt to changing priorities, and effectively influence cross-functional teams in a fast-paced product development environment.

Responsibility:

·         Partner with cross-functional engineering, product management, clinical, regulatory, and project management teams to support new product development and design changes to commercial products.

·         Provide Quality leadership throughout the product development lifecycle, ensuring design controls and risk management activities are effectively planned and executed.

·         Ensure compliance with applicable design control, risk management, and quality system requirements for new product development and sustaining engineering projects.

·         Lead and facilitate Design Assurance activities including design planning, design reviews, risk management, design verification and validation planning, design transfer, and design change management.

·         Review design documentation to ensure requirements, design outputs, verification, validation, and risk management activities are complete, consistent, and traceable.

·         Ensure Design History Files (DHFs), Technical Documentation, and associated design records are complete, accurate, inspection-ready, and compliant with regulatory requirements.

·         Provide Quality oversight for engineering change activities, assessing the impact of design changes on product performance, risk, regulatory submissions, and existing documentation.

·         Partner with engineering teams to ensure product risks are appropriately identified, evaluated, controlled, and monitored throughout the product lifecycle.

·         Support broader Quality Management System activities including CAPA, nonconformance investigations, supplier quality, internal and external audits, and continuous improvement initiatives as needed.

·         Drive a culture of quality by coaching cross-functional teams on Design Controls, Risk Management, and Quality System requirements.

·         Collaborate with Regulatory Affairs to support global regulatory submissions and responses related to product development activities.

·         Identify opportunities to improve product development processes and Quality System effectiveness through metrics, lessons learned, and continuous improvement initiatives.

·         Serve as the Design Assurance Subject Matter Expert (SME) during internal audits, Notified Body audits, FDA inspections, and other regulatory assessments, providing support for Design Controls, Risk Management, Technical Documentation, and Design History File compliance.

Requirements

• Bachelor's degree in Engineering, Life Sciences, or another technical discipline; advanced degree is a plus.
• Minimum 5–8 years of experience in Quality Engineering, Design Assurance, or Product Development Quality within the medical device industry.
• Demonstrated experience supporting new product development from concept through commercialization under Design Control requirements.
• Strong working knowledge of medical device Quality System Regulations and international standards, including:
• ISO 13485
• FDA 21 CFR Part 820 / QMSR
• ISO 14971
• EU MDR
• IEC 62366 (Usability Engineering)
• IEC 60601 and IEC 62304, as applicable to the product.
• Experience with design changes, sustaining engineering, and lifecycle management of commercial medical devices.
• Strong understanding of Design Controls, Design Reviews, Design Verification & Validation, Risk Management, and Design Transfer.
• Experience serving as the Design Assurance or Quality Engineering Subject Matter Expert (SME) during Notified Body audits, FDA inspections, and internal/external Quality System audits, with demonstrated success supporting Design Control and product development compliance.
• Demonstrated ability to lead cross-functional teams and influence technical decisions without direct authority.
• Strong project management, organizational, and prioritization skills with the ability to manage multiple projects simultaneously.
• Strong analytical and problem-solving skills with experience facilitating risk-based decision making.
• Excellent written and verbal communication skills.
• Proficient with Microsoft Office applications and electronic Quality Management Systems (eQMS) and Product Lifecycle Management (PLM) systems.
• Self-motivated with a collaborative, hands-on approach and the ability to thrive in a fast-paced product development environment.

Benefits

• Competitive compensation package based on experience.
• Flexible work location (hybrid work schedule) and occasional international travel as required (10% of time)