Principal Manufacturing Engineer (Implantable Device)

Location: Cambridge, MA, United States

Salary: $159,000–$219,000 per year

Company

hirify.global is a mid-sized biotechnology company developing life-changing medicines and operating with a focus on scientific innovation, inclusion, and collaboration.

What you will do

• Lead end-to-end manufacturing strategy, scale-up, lifecycle management, and commercialization for Class III implantable drug delivery systems.
• Define manufacturing standards, control strategies, inspection strategies, validation plans, and compliance documentation.
• Serve as the technical authority for contract manufacturers, suppliers, tooling, assembly approaches, and supply chain optimization.
• Transfer product designs into scalable, robust manufacturing processes and resolve day-to-day manufacturing issues.
• Drive manufacturing technology roadmaps, process innovation, continuous improvement, and external industry engagement.
• Provide subject-matter expertise to development, quality, regulatory, and supply chain teams while influencing cross-functional decisions.

Requirements

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

Culture & Benefits

• Full-time employment with medical, dental, vision, and life insurance.
• Short- and long-term disability insurance, paid vacation, sick time, holidays, and parental leave.
• Short-term and long-term incentives, including cash bonus and equity opportunities.
• 401(k) plan with company matching and an employee stock purchase plan.
• Fitness and wellness programs, tuition reimbursement of up to $10,000 per year, and employee resource groups.
• Inclusive environment focused on collaboration, learning, professional growth, and employee well-being.