Director, Design Assurance

Nova Biomedical; Waltham (MA); Hybrid; USD 175,000 - 240,000; Full time

Benefits offered by this job

Hybrid work arrangements

401k match

Bonus program

Generous PTO and holidays

Office marketplace for lunch and snack

Job summary

Nova Biomedical in Massachusetts seeks a Director, Design Assurance to lead global design controls and quality systems for medical devices, ensuring compliance with FDA QMSR, ISO standards, and regulatory requirements.

The role partners with R&D, Regulatory Affairs, Manufacturing, and others to support product development, design transfer, and lifecycle management, including design reviews and governance across software-enabled devices.

Qualifications

• Bachelor's degree in a technical field required; advanced degree preferred.
• Minimum 15 years in medical device/regulated healthcare.
• Minimum 10 years of progressive leadership in quality/design assurance.
• Experience supporting FDA inspections and international audits.
• Experience with Class II medical devices and product lifecycle management.
• Strong knowledge of FDA QMSR, ISO 13485, ISO 14971, ISO 9001, IVDR, MDSAP.

Responsibilities

• Lead and continuously improve global Design Assurance for new product development and lifecycle management.
• Establish and maintain design control processes, including planning, inputs/outputs, reviews, verification, validation, and changes.
• Integrate risk management across product lifecycle per ISO 14971.
• Provide leadership to ensure compliance and meet customer quality expectations.
• Govern Design and Development Files with traceability and audit readiness.
• Oversee software lifecycle quality, cybersecurity considerations, and evidence.

Skills

Leadership

Quality systems

Regulatory affairs

Cross-functional collaboration

Risk management

Education

Bachelor's degree in Engineering/QA/Regulatory Affairs

Tools

QMS software

Document control systems

Job description

Nova Biomedical: One Global Brand. One Vision. Together under one name.

Advanced Instruments and Nova Biomedical are now united under one brand, Nova Biomedical, marking a major milestone in our journey to deliver greater value to our customers. By combining our strengths, we're accelerating innovation, supporting critical workflows, and delivering world-class service across the biopharmaceutical and clinical markets.

Job Summary:

The Director, Design Assurance provides global leadership for Design Assurance and Design Control activities across the organization. This position is responsible for ensuring compliance with the 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.

The role supports both regulated medical devices and Nova's non-medical bioprocessing portfolio, applying scalable, risk-based Quality approaches appropriate to the regulatory, customer, and business requirements applicable to each product area, including quality expectations associated with supplying customers operating in GMP-regulated environments. The Director partners closely with Research & Development, Regulatory Affairs, Manufacturing, Supply Chain, Technical Services, Commercial, and other functions to support effective product development, change management, design transfer, and lifecycle management.

Responsibilities:

Design Assurance Leadership

• Lead and continuously improve the global Design Assurance function for new product development, product changes, sustaining engineering activities, and lifecycle management.
• Establish and maintain effective and compliant design control processes, including design planning, design inputs, design outputs, design reviews, verification, validation, design transfer, and design changes.
• Ensure risk management activities are effectively 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 compliance with applicable regulations, standards, and corporate procedures and to promote development of products that meet defined customer quality, performance, and reliability expectations.
• Establish and maintain governance for Design and Development Files, including requirements for traceability, completeness, lifecycle maintenance, remediation where required, 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/change control, release readiness, and appropriate integration of cybersecurity requirements and evidence.
• Provide Quality oversight of applicable clinical, analytical, performance, verification/validation, and stability studies, ensuring appropriate study design, acceptance criteria, sampling and statistical approaches, data analysis, and conclusions.
• Partner with R&D, Regulatory Affairs, Manufacturing, Program Management, and other functions to support successful product development, commercialization, design transfer, and lifecycle management, including participation in design reviews and applicable quality governance activities.

Leadership & Organizational Development

• Lead, develop, and mentor the global Design Assurance team, establishing clear goals, capabilities, succession plans, and performance expectations.
• Manage staffing, budgets, resource allocation, and external support necessary to meet business and functional priorities.
• Build scalable organizational capabilities and drive a culture of quality, accountability, customer focus, and continuous improvement.
• Support regulatory inspections, notified body and customer audits, and related compliance activities within assigned areas of responsibility.

Experience Requirements:

• Bachelor's degree in Engineering, Life Sciences, Quality Management, Regulatory Affairs, or a related technical discipline required; Master's degree in Engineering, Business Administration, Quality, or related field preferred.
• Minimum 15 years of experience within medical device, in vitro diagnostic, biotechnology, or regulated healthcare industries.
• Minimum 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 associated with product development and commercialization of Class II medical devices and/or biotechnology analyzers.
• Demonstrated experience working 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 associated risk management practices.
• Demonstrated knowledge of product performance evaluation and study design, including appropriate application of statistical methods, sampling approaches, acceptance criteria, and analysis of verification, validation, analytical, performance, and stability data.
• Understanding of quality system expectations applicable to non-medical products operating under ISO 9001 and experience supporting customers or markets with demanding supplier-quality requirements; experience supporting suppliers to GMP-regulated industries preferred.
• 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, with demonstrated success leading cross-functional teams and complex quality improvement initiatives.
• Ability to effectively interface with executive leadership, regulatory agencies, auditors, customers, and global business partners.
• ASQ certifications (CQE, CQA, CMQ/OE) or equivalent professional certifications preferred.

Physical Requirements and Working Conditions:

• Ability to work in an office and manufacturing environment.
• Ability to sit, stand, and use computer equipment for extended periods.
• Ability to occasionally lift up to 35 pounds.

Why Work for Nova Biomedical

Competitive 401k company match

Bonus Program, Generous PTO and paid holidays

Hybrid and flexible work arrangements

Professional development, engagement and events

Company marketplace for lunch and snacks in our Norwood, MA, Billerica, MA and Westbrook, ME offices

Company subsidized cafeteria in our Waltham, MA office

Work Location: Hybrid in Waltham, MA

Targeted Salary Range: $175,000-$240,000/year

Nova Biomedical believes in transparency and integrity throughout all we do, including compensation. The provided salary range for this role represents the expected base salary or hourly rate for this opening. Actual compensation will be commensurate with the candidate’s experience and may vary based on individual factors such as location, skills, and education.

About the company

At Nova Biomedical, we’re not just building instruments, we’re powering breakthroughs that improve lives. Our smart, science-driven solutions are trusted in over 100 countries to speed drug development and enhance patient care.

Our integration brings together more than 70 years of scientific excellence with Nova’s cutting‑edge innovation, forming a powerhouse of precision, purpose, and possibility. With FDA‑registered, ISO‑certified manufacturing, more than 125 FDA approvals, and industry‑trusted diagnostics, we’re setting new standards in quality and reliability. Nova Biomedical is proud to be a global leader in osmolality testing and biotechnology and in vitro diagnostic (IVD) instrumentation, dedicated to advancing patient care and scientific discovery with a legacy that continues to shape the future of life sciences.

With headquarters in Norwood and Waltham, Massachusetts, and a global team of nearly 2,000 employees, we’re building a collaborative, empowered culture grounded in shared values: Customer Centricity, Ingenuity, Ownership & Accountability, Collaboration, and Integrity.

Working at Nova Biomedical means joining a mission‑driven organization where your contributions matter. Whether you're in engineering, science, manufacturing, or support, you’ll be part of a team that values innovation, invests in your growth, and is committed to making a real‑world impact on global health.

Nova Biomedical takes pride in being an equal opportunity employer committed to hiring a diverse and inclusive workforce. As a part of our commitment to a diverse and inclusive workforce, Nova Biomedical will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.