Principal Manufacturing Engineer (Medtech)

TL;DR

Principal Manufacturing Engineer (Medtech): Driving manufacturing strategies and execution for Class III implantable drug delivery systems with an accent on scale-up, process validation, and lifecycle management. Focus on establishing manufacturing standards, managing contract manufacturers, and ensuring compliance with FDA and ISO regulatory requirements.

Location: Cambridge, MA (USA)

Salary: $159,000–$219,000

Company

hirify.global is a global biotechnology company dedicated to developing life-changing medicines through innovation and a commitment to excellence.

What you will do

• Lead end-to-end manufacturing strategy, scale-up, and lifecycle management for implantable device programs.
• Define and implement manufacturing standards, control strategies, and best practices.
• Serve as the primary technical authority for contract manufacturers, driving performance and innovation.
• Influence cross-functional decisions regarding development, quality, regulatory, and supply chain strategies.
• Drive manufacturing technology roadmaps, process innovation, and continuous improvement initiatives.
• Represent the organization externally through industry engagement and collaboration.

Requirements

• Bachelor’s degree in Biomedical, Mechanical, or Manufacturing Engineering.
• 10+ years of manufacturing engineering experience in the medical device industry.
• Proven experience with Class III implantable devices and drug delivery systems.
• Demonstrated expertise in manufacturing scale-up, process validation, and commercialization.
• Strong knowledge of FDA QSR, ISO 13485, and ISO 14971 requirements.
• Experience leading cross-functional teams and managing external partnerships.

Culture & Benefits

• Comprehensive medical, dental, vision, and life insurance plans.
• 401(k) program with company matching contributions.
• Generous paid time off including 15+ vacation days, end-of-year shutdown, and 12+ holidays.
• Paid maternity and parental leave benefits.
• Tuition reimbursement up to $10,000 per calendar year.
• Fitness and wellness programs with reimbursement options.