Senior Director Design Quality (MedTech)

Location: Danvers, Massachusetts, United States of America; domestic and international travel up to 25%

Base pay: $196,000.00–$342,700.00 per year

Company

Johnson & Johnson MedTech develops healthcare technologies and medical devices aimed at improving patient outcomes.

What you will do

• Provide strategic leadership for Design Quality across the Heart Recovery product portfolio.
• Lead and develop a global Design Quality organization supporting product development, sustaining engineering, and lifecycle management.
• Oversee design planning, risk management, verification, validation, design transfer, commercialization, and design change activities.
• Ensure compliance with FDA Quality System Regulation, ISO 13485, ISO 14971, IEC 62304, IEC 62366, EU MDR, MDSAP, and other global requirements.
• Partner with R&D, Regulatory Affairs, Clinical, Manufacturing, Supply Chain, Risk Management, and Commercial teams.
• Represent Design Quality in audits, regulatory inspections, design reviews, phase gates, product governance, and regulatory interactions.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, Quality, or a related technical discipline.
• At least 15 years of progressive experience in the medical device industry and 10 years of leadership experience in Quality, Design Quality, or related functions.
• Experience supporting Class II and/or Class III medical devices through product development and commercialization.
• Expert knowledge of design controls and risk management principles, with experience supporting regulatory inspections and external audits.
• Experience leading large, global, cross-functional teams in a matrix environment.
• Strong strategic thinking, executive leadership, communication, decision-making, talent management, and organizational development skills.

Nice to have

• Cardiovascular and/or heart failure device experience.
• ASQ Certified Quality Engineer, Certified Manager of Quality/Organizational Excellence, or equivalent certification.

Culture & Benefits

• Retirement pension and 401(k) savings plan participation.
• Eligibility for a long-term incentive program.
• Vacation, sick time, holiday pay, personal and family time, parental leave, bereavement leave, caregiver leave, volunteer leave, and military spouse time-off.
• Work in an inclusive environment focused on patient safety, product quality, regulatory compliance, and continuous improvement.