Director, Design Assurance

Nova Biomedical • Waltham, MA

3d • Hybrid

About The Position

The Director, Design Assurance provides global leadership for Design Assurance and Design Control activities across Nova Biomedical. The role ensures compliance with FDA Quality Management System Regulation (QMSR), ISO 13485, ISO 14971, ISO 9001, applicable international regulatory requirements, and internal quality system requirements throughout the product lifecycle. It supports regulated medical devices and the non-medical bioprocessing portfolio, applying scalable, risk-based Quality approaches that fit relevant regulatory, customer, and business requirements, including expectations for customers operating in GMP-regulated environments.

The Director partners with Research & Development, Regulatory Affairs, Manufacturing, Supply Chain, Technical Services, Commercial, and other functions to support product development, change management, design transfer, commercialization, and lifecycle management. The position leads the global Design Assurance team and function, oversees design controls, product risk management, software lifecycle quality, product studies, and Design and Development File governance, and supports inspections and audits.

The role is hybrid in Waltham, Massachusetts. The targeted base salary range is $175,000–$240,000 per year.

Requirements

• Bachelor's degree in Engineering, Life Sciences, Quality Management, Regulatory Affairs, or a related technical discipline.
• At least 15 years of experience in medical device, in vitro diagnostic, biotechnology, or regulated healthcare industries.
• At least 10 years of progressive leadership experience managing quality, Design Assurance, design controls, or Document Control functions.
• Demonstrated experience supporting FDA inspections, notified body audits, and international regulatory assessments.
• Experience leading quality initiatives for product development and commercialization of Class II medical devices and/or biotechnology analyzers.
• Experience across complex product-development lifecycles, including design controls, risk management, verification and validation, design transfer, product changes, and controlled product documentation.
• Comprehensive knowledge of FDA QMSR, ISO 13485, ISO 14971, ISO 9001, IVDR, MDSAP, and applicable global medical device quality system requirements.
• Strong understanding of design controls, risk management, usability engineering, verification and validation, design transfer, Design and Development File governance, and product lifecycle management.
• Strong understanding of software lifecycle quality requirements and experience providing Quality oversight of software-containing products.
• Knowledge of medical device cybersecurity expectations and related risk management practices.
• Knowledge of product performance evaluation and study design, including statistical methods, sampling approaches, acceptance criteria, and analysis of verification, validation, analytical, performance, and stability data.
• Understanding of quality system expectations for non-medical products operating under ISO 9001 and experience supporting customers or markets with demanding supplier-quality requirements.
• Experience with electronic document management systems and controlled workflows, engineering change processes, records management, and interfaces with engineering configuration and product data management systems.
• Excellent leadership, organizational, communication, analytical, and problem-solving skills, including demonstrated success leading cross-functional teams and complex quality improvement initiatives.
• Ability to interface effectively with executive leadership, regulatory agencies, auditors, customers, and global business partners.
• Ability to work in an office and manufacturing environment, sit and stand, and use computer equipment for extended periods; ability to occasionally lift up to 35 pounds.

Nice To Haves

• Master's degree in Engineering, Business Administration, Quality, or a related field.
• Experience supporting suppliers to GMP-regulated industries.
• ASQ certifications (CQE, CQA, CMQ/OE) or equivalent professional certifications.

Responsibilities

• Lead and continuously improve the global Design Assurance function for new product development, product changes, sustaining engineering, and lifecycle management.
• Establish and maintain compliant design control processes covering design planning, inputs, outputs, reviews, verification, validation, design transfer, and design changes.
• Ensure risk management is integrated throughout the product lifecycle in accordance with ISO 14971 and other applicable requirements.
• Provide Quality leadership and oversight for product development programs to ensure regulatory, standards, and corporate-procedure compliance and support products that meet customer quality, performance, and reliability expectations.
• Establish and maintain governance for Design and Development Files, including traceability, completeness, lifecycle maintenance, remediation, and audit/inspection readiness.
• Provide Design Assurance leadership and oversight for product software throughout the applicable software lifecycle, including software risk management, verification and validation, configuration and change control, release readiness, and cybersecurity requirements and evidence.
• Provide Quality oversight of applicable clinical, analytical, performance, verification/validation, and stability studies, including study design, acceptance criteria, sampling and statistical approaches, data analysis, and conclusions.
• Partner with R&D, Regulatory Affairs, Manufacturing, Program Management, and other functions on product development, commercialization, design transfer, and lifecycle management, including participation in design reviews and quality governance.
• Lead, develop, and mentor the global Design Assurance team; establish goals, capabilities, succession plans, and performance expectations.
• Manage staffing, budgets, resource allocation, and external support to meet business and functional priorities.
• Build scalable organizational capabilities and promote quality, accountability, customer focus, and continuous improvement.
• Support regulatory inspections, notified body and customer audits, and related compliance activities within assigned areas.

Benefits

• Flexible medical, dental, and vision coverage
• Competitive 401(k) company match
• Bonus program
• Generous PTO and paid holidays
• Tuition reimbursement
• Hybrid and flexible work arrangements
• Professional development, engagement, and events
• Company marketplace for lunch and snacks at the Norwood, Billerica, and Westbrook offices
• Company-subsidized cafeteria at the Waltham office

What This Job Offers

• Job Type: Full-time
• Career Level: Director