Associate Manager, Combination Products (Sustaining)

Location: Onsite in East Greenbush, New York, United States; Monday–Friday, 8:00am–4:30pm

Salary: $92,200–$176,000 annually

Company

hirify.global is a biotechnology company that develops and commercializes medicines for serious diseases.

What you will do

• Lead and mentor sustaining engineers supporting commercial combination products throughout their lifecycle.
• Own design changes from concept through launch to improve product quality, reliability, and customer experience.
• Lead customer complaint investigations, identify root causes, and implement corrective and preventive actions.
• Use post-market feedback to support new product development and risk management.
• Facilitate design transfer of existing products to new manufacturing sites and support contract manufacturing changes.
• Coordinate cross-functional teams and external partners while balancing technical constraints and business objectives.

Requirements

• Bachelor’s degree in Engineering; Biomedical, Mechanical, or Industrial Engineering is preferred.
• At least 6 years of sustaining engineering experience for the Associate Manager level; 7+ years may qualify for the Manager level.
• Previous supervisory or people leadership experience.
• Experience manufacturing medical devices and/or combination products.
• Strong understanding of FDA regulations for combination products, including 21 CFR Part 3 and design controls under 21 CFR 820.30.
• Hands-on experience with Design History Files, analytical problem-solving, technical writing, and oral communication.

Culture & Benefits

• Inclusive workplace with equal employment opportunity practices.
• Comprehensive total rewards package may include annual bonuses, equity awards, retirement benefits, 401(k) matching, insurance, paid time off, and family support benefits.
• Onsite collaboration is emphasized for many roles.

Hiring process

• Background checks may verify identity, right to work, and educational qualifications where permitted by law.
• Reasonable accommodations are available during recruitment for applicants with qualifying disabilities or chronic illnesses.