<p>At Johnson & Johnson,?we believe health is everything. Our strength in healthcare innovation empowers us to build a?world where complex diseases are prevented, treated, and cured,?where treatments are smarter and less invasive, and?solutions are personal.?Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.?Learn more at https://www.jnj.com</p> <p>Job Function:</p> <p>R&D Product Development</p> <p>Job Sub Function:</p> <p>Multi-Family R&D Product Development</p> <p>Job Category:</p> <p>People Leader</p> <p>All Job Posting Locations:</p> <p>Malvern, Pennsylvania, United States of America</p> <p>Job Description:</p> <p>About Innovative Medicine</p> <p>Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.</p> <p>Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.</p> <p>Learn more at https://www.jnj.com/innovative-medicine</p> <p>We are searching for the best talent for Director, Head of Subcutaneous Platform Device Engineering in Malvern, PA.</p> <p>Purpose: The Director, Head of Subcutaneous Platform Device Engineering, will lead the strategy, development, and lifecycle management of the company's subcutaneous (SC) delivery platform (across the JJIM portfolio, including synthetic molecules, biologics, and advanced therapies), including manual injectors, autoinjectors, novel SC delivery systems, and primary container integration. This leader will build and guide a high-performing team of engineers and cross-functional partners to enable robust, customer-centric drug-device combination products across the portfolio.</p> <p>The ideal candidate is a strategic, driven, motivated, hands-on engineering leader with deep expertise in drug delivery devices, strong understanding of formulation-device interplay, quality, regulatory and proven ability to drive platform standardization, innovation, and global regulatory readiness.</p> <p>You will be responsible for:</p> <p>Strategic Leadership:</p> <ul> <li>Define and drive the vision and roadmap for the subcutaneous platform device engineering function. Lead technical development of drug delivery devices from concept through commercialization. </li><li>Establish platform standards, modular architectures, and technology building blocks to accelerate program execution across multiple therapeutic areas. </li><li>Partner closely with formulation, primary container development, human factors, quality, regulatory, and CMC teams to ensure integrated drug-device strategies. </li><li>Oversee design, execution, and analysis of technical evaluation plans and experiments (internal and external sites). </li><li>Contribute to regulatory submissions for combination products (IND, NDA, etc.). </li><li>Manage technology transfer for combination product manufacturing to clinical and commercial sites. </li><li>Support device product quality investigations, CAPAs, and change control activities. </li><li>Communicate project goals, progress, and results effectively across functions and departments. </li><li>Foster a culture of innovation, collaboration, and continuous improvement within the team. </li></ul> <p>Technical & Program Leadership:</p> <ul> <li>Lead engineering development of SC delivery systems including autoinjectors, prefilled syringes, needle safety devices, on-body delivery systems, and novel SC injection technologies. </li><li>Oversee design control, risk management, verification/validation, DFM/DFA, and human-centric engineering principles. </li><li>Own technical decisions related to mechanical, electromechanical, and connected-device design, ensuring performance, reliability, and patient usability. </li><li>Support technical due diligence for external technologies, suppliers, and platform partnerships. </li></ul> <p>Operational Excellence:</p> <ul> <li>Build and lead a high-performing team; mentor, coach, and develop engineering talent. </li><li>Implement best-in-class process frameworks for device development, design transfer, and lifecycle management. </li><li>Ensure robust supplier and manufacturing engagement to scale device solutions globally. </li><li>Drive issue resolution, continuous improvement, and platform harmonization across programs. </li></ul> <p>Regulatory & Quality:</p> <ul> <li>Ensure compliance with global combination product and medical device regulations. </li><li>Provide engineering leadership during regulatory submissions, inspections, and authority interactions. </li><li>Champion robust risk management per ISO 14971. </li></ul> <p>Qualifications/Requirements:</p> <p>Education: Minimum of Master's Degree in Mechanical Engineering, Biomedical Engineering, Materials Science, or related field is required. PhD is preferred.</p> <p>Skills/Experience:</p> <ul> <li>Minimum of 10 years of experience in medical device or drug-device combination product development, with substantial work in SC systems is required. </li><li>Demonstrated success delivering commercial or late-stage device programs. </li><li>Strong understanding of primary container systems and formulation-device compatibility. </li><li>Proven experience in a matrixed pharma/biotech environment. </li><li>Excellent strategic thinking, communication, and leadership skills. </li><li>Experience with connected/smart devices is a strong plus. </li></ul> <p>Key Competencies</p> <ul> <li>Strategic leadership & vision </li><li>Deep device engineering expertise </li><li>Cross-functional influence </li><li>Technical rigor and problem-solving </li><li>Patient-centered design thinking </li><li>Supplier & external partnership management </li><li>Execution excellence </li></ul> <p>Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.</p> <p>Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.</p> <p>Required Skills:</p> <p>Preferred Skills:</p> <p>Creating Purpose, Developing Others, Entrepreneurship, Inclusive Leadership, Leadership, Operations Management, Process Improvements, Product Development, Product Development Lifecycle, Product Strategies, Program Management, Quality Assurance (QA), Research and Development, Research Ethics, SAP Product Lifecycle Management, Stakeholder Engagement, Technical Credibility, Versatility</p>