Senior Quality Engineer - Product Development

• Bachelor's degree in Engineering, Life Sciences, or another technical discipline; advanced degree is a plus
• 5+ years of experience in Quality Engineering, Design Assurance, or Product Development Quality within the medical device industry, including new product development from concept through commercialization under Design Control requirements
• Strong working knowledge of medical device Quality System regulations and international standards: ISO 13485, FDA 21 CFR Part 820/QMSR, ISO 14971, EU MDR, IEC 62366, and IEC 60601/62304 as applicable to the product
• Solid experience with Design Controls, Design Reviews, Design Verification & Validation, Risk Management, Design Transfer, and sustaining engineering/lifecycle management of commercial medical devices
• Demonstrated experience serving as Design Assurance or Quality Engineering SME during Notified Body audits, FDA inspections, and internal/external Quality System audits
• Proven ability to lead and influence cross-functional teams without direct authority, with strong project management, organizational, analytical, and risk-based decision-making skills
• Excellent written and verbal communication skills; proficient with Microsoft Office, eQMS, and PLM systems; self-motivated and collaborative in a fast-paced environment

This role provides Quality Engineering leadership across Design Controls, Risk Management, and Quality System requirements throughout the product development lifecycle, partnering with Engineering, Product Management, Clinical, Regulatory Affairs, and Project Management to bring new products and design changes to commercial products in compliance with global medical device regulations. As a key Design Assurance resource, the Senior Quality Engineer works independently in a fast-paced environment to ensure design documentation is complete, compliant, and inspection-ready.

• Partner with cross-functional teams (Engineering, Product Management, Clinical, Regulatory Affairs, Project Management) to support new product development and design changes to commercial products
• Provide Quality leadership and ensure compliance with Design Controls, Risk Management, and Quality System requirements throughout new product development and sustaining engineering projects
• Lead and facilitate Design Assurance activities: design planning, design reviews, verification & validation planning, design transfer, and design change management
• Review design documentation and Design History Files (DHFs)/Technical Documentation to ensure requirements, outputs, verification, validation, and risk management activities are complete, traceable, and inspection-ready
• Assess the impact of engineering changes on product performance, risk, regulatory submissions, and documentation, and ensure product risks are identified, evaluated, and controlled throughout the lifecycle
• Support broader Quality Management System activities (CAPA, nonconformance investigations, supplier quality, audits) and drive a culture of quality by coaching cross-functional teams; collaborate with Regulatory Affairs on global submissions
• Serve as Design Assurance SME during internal, Notified Body, and FDA audits/inspections, and identify opportunities to improve product development processes and Quality System effectiveness

• Quality is integrated early into Design Controls, resolving compliance and product risks before they cause delays - and cross-functional teams see Quality as a proactive partner that enables efficient development, not a bottleneck
• Audits and inspections show strong Design Control and Risk Management execution, with minimal findings and timely resolution of any gaps
• Quality and product development processes continuously improve, reducing documentation gaps, late-stage remediation, and Quality-related delays to commercialization

At Hilo by Aktiia, our values guide everything we do:

• Move the Needle - You focus on what truly drives impact for our customers and company. - You use data and clarity to guide your decisions and prioritise what matters most. - Content here is accountable, measured in awareness, recall, and share of voice, not vibes.
• Move Fast, Learn, Refine - You work with urgency and purpose, balancing speed with high quality. - You treat mistakes as learning opportunities, experiment thoughtfully, and iterate quickly. - You ship the brief and the campaign rather than wait for the perfect deck.
• Team First - You put the team above individual interests, building trust through openness and respect. - You encourage healthy debate, challenge directly while caring personally, and stand behind team decisions. - You own the content outcome while working through a freelance PR lead, your agency partners, and a close partnership with the Head of Design and Paid.