Senior Director, Device Development - Product Delivery Solutions (Medical Devices)

TL;DR

Senior Director, Device Development - Product Delivery Solutions (Medical Devices): Leading the selection, technical development, and lifecycle management of drug-device combination platforms with an accent on subcutaneous delivery systems, autoinjectors, and prefilled syringes. Focus on advancing novel technologies from concept to commercialization and ensuring operational rigor within global regulatory frameworks.

Location: Hybrid Cambridge, MA

Salary: $225,000 - $310,000

Company

hirify.global is a global mid-sized biotechnology company dedicated to delivering life-changing medicines through a pioneering spirit and a culture of inclusion.

What you will do

• Define and execute the end-to-end strategy for drug-device combination product development from concept through commercialization.
• Translate early molecule needs into device roadmaps, specifically emphasizing subcutaneous delivery strategies.
• Lead technical execution of the design control process, overseeing prototyping, verification, and validation activities.
• Direct root cause investigations, deviations, and CAPAs to ensure device reliability and manufacturability.
• Lead multidisciplinary engineering teams and manage device development laboratories to accelerate risk reduction.
• Cultivate strategic relationships with external partners and represent the company in global industry forums.

Requirements

• Bachelor’s degree in Engineering with 15+ years of experience, or MS + 12 years, or PhD + 8 years.
• Extensive experience in drug-device combination product development within the pharmaceutical or medical device industry.
• Must be based in or able to work hybrid in Cambridge, MA.
• Deep expertise in design controls, human factors, and regulatory requirements.
• Proven track record of managing complex technical projects and developing strategic device solutions.
• Experience with model-informed development practices and digital twin simulation.

Culture & Benefits

• Comprehensive medical, dental, vision, and life insurance.
• 401(k) program with company matched contributions.
• Minimum 15 days of paid vacation plus an end-of-year company shutdown.
• Paid maternity and parental leave benefits.
• Tuition reimbursement up to $10,000 per calendar year.
• Fitness reimbursement and wellness programs.