Director, Design Assurance (Medical Devices)

Location: Hybrid in Waltham, Massachusetts, United States. The role requires working in office and manufacturing environments.

Salary: $175,000–$240,000 per year.

Company

hirify.global develops medical devices, in vitro diagnostic instrumentation, biotechnology solutions, and bioprocessing products for clinical and biopharmaceutical markets.

What you will do

• Lead and continuously improve the global Design Assurance function across new product development, product changes, sustaining engineering, and lifecycle management.
• Establish compliant design control processes covering planning, inputs, outputs, reviews, verification, validation, design transfer, and design changes.
• Integrate risk management, software lifecycle quality, cybersecurity requirements, and Design and Development File governance throughout the product lifecycle.
• Provide Quality oversight for clinical, analytical, performance, verification, validation, and stability studies, including study design, acceptance criteria, sampling, statistics, data analysis, and conclusions.
• Partner with R&D, Regulatory Affairs, Manufacturing, Program Management, Supply Chain, Technical Services, Commercial, and other functions on development, commercialization, design transfer, and lifecycle management.
• Lead and mentor the global Design Assurance team, manage staffing and budgets, build organizational capabilities, and support regulatory inspections and audits.

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 devices, in vitro diagnostics, biotechnology, or regulated healthcare, including at least 10 years of progressive leadership experience managing Quality, Design Assurance, design controls, or Document Control functions.
• Experience supporting FDA inspections, notified body audits, and international regulatory assessments.
• Experience leading quality initiatives for 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 knowledge of design controls, usability engineering, Design and Development File governance, product lifecycle management, software lifecycle quality, and medical device cybersecurity risk management.
• Knowledge of product performance evaluation and study design, including statistical methods, sampling, acceptance criteria, and analysis of verification, validation, analytical, performance, and stability data.
• Experience with electronic document management systems, controlled workflows, engineering change processes, records management, configuration systems, and product data management interfaces.
• Excellent leadership, communication, analytical, organizational, and problem-solving skills, including 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 office and manufacturing environments and occasionally lift up to 35 pounds.

Nice to have

• Master’s degree in Engineering, Business Administration, Quality, or a related field.
• Experience supporting customers or markets with demanding supplier-quality requirements and suppliers serving GMP-regulated industries.
• ASQ certification such as CQE, CQA, or CMQ/OE, or an equivalent professional certification.

Culture & Benefits

• Hybrid and flexible work arrangements.
• Medical, dental, and vision coverage, competitive 401(k) matching, bonus program, generous PTO, and paid holidays.
• Tuition reimbursement and professional development opportunities.
• Engagement and company events, with lunch and snack marketplaces at selected offices and a subsidized cafeteria in Waltham.
• Culture grounded in customer centricity, ingenuity, ownership and accountability, collaboration, and integrity.