Senior Director, New Product Development (Medical Devices)

Location: Fremont, California, United States; onsite role

Salary: $202,500–$337,500 per year

Company

hirify.global develops and manufactures medical devices and components, including Nitinol products, stents, catheters, biomedical textiles, and precision polymer tubing.

What you will do

• Set and execute long-term product development and technology strategies aligned with business, customer, and market objectives.
• Lead a portfolio of customer-funded and internally sponsored programs from concept through commercialization and manufacturing transfer.
• Direct a multidisciplinary organization of directors, managers, engineers, scientists, and technical personnel.
• Drive emerging technology adoption, engineering excellence, innovation, and continuous improvement.
• Partner with Commercial, Operations, Quality, Regulatory, Program Management, and Manufacturing teams on customer growth, production scale-up, and operational readiness.
• Manage budgets, capital plans, resource strategies, performance indicators, and portfolio outcomes.

Requirements

• Bachelor’s degree in engineering, biomedical engineering, materials science, mechanical engineering, chemical engineering, life sciences, or a related technical discipline.
• 18+ years of progressive engineering, product development, and technical leadership experience in the medical device industry.
• 10+ years of experience leading managers and senior technical leaders, including large multidisciplinary product development organizations.
• Extensive experience developing Class II and Class III medical devices from concept through commercialization.
• Strong expertise in Design Controls, Risk Management, Verification & Validation, Process Development, and Manufacturing Transfer.
• Employment visas are not sponsored, and candidates on time-limited visa status are not considered.

Nice to have

• Master’s degree, MBA, PhD, or another advanced degree.
• Experience in cardiovascular, structural heart, electrophysiology, neurovascular, peripheral vascular, surgical, orthopedic, robotic, or minimally invasive medical devices.
• Experience in a contract development and manufacturing organization or a multi-site global development and manufacturing environment.
• Lean Six Sigma Green Belt or Black Belt certification and/or PMP certification.

Culture & Benefits

• Collaborative, high-impact environment focused on life-saving medical solutions.
• Opportunity to influence product development, manufacturing outcomes, technology investment, and business strategy.
• Culture centered on innovation, accountability, collaboration, customer focus, quality, and continuous improvement.
• Work across diverse technologies and broad material science capabilities.