Manager, Combination Product Development (Manufacturing)

TL;DR

Manager, Combination Product Development (Manufacturing): Supporting manufacturing operations by analyzing data and initiating investigations, deviations, and change controls to improve process robustness and product quality. Focus on device development, risk management, and ensuring compliance with GxP and regulatory standards.

Location: Hybrid role based in Bridgewater, NJ

Salary: $124,000–$161,000 Annual

Company

hirify.global is a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases.

What you will do

• Analyze process and product data to generate lifecycle metrics using statistical analysis.
• Lead manufacturing and complaint trend investigations involving devices and combination products.
• Manage change control processes and perform technical assessments for design or process changes.
• Serve as the primary point of contact for device manufacturers and organize regular technical meetings.
• Represent the team in CMC meetings to assess the impact on devices and combination products.
• Review labeling, IFU, and training material changes for technical accuracy.

Requirements

• Bachelor’s degree and 5+ years of experience in engineering or operations.
• Proven experience in Design Control, Risk Management, and CAPA lifecycle.
• Working knowledge of FDA Quality System Regulation (21 CFR Part 820), ISO 13485:2016, ISO 14971:2007, and EU Medical Device Regulation.
• Strong proficiency in Microsoft Office suite.
• Excellent verbal and written communication skills.
• Ability to work effectively within cross-functional teams.

Nice to have

• Certified Quality Engineer (CQE) or similar certification.
• Statistical expertise, particularly with Minitab or similar tools.

Culture & Benefits

• Comprehensive medical, dental, and vision coverage with mental health support.
• 401(k) plan with company match and annual equity awards.
• Generous paid time off and flexible work schedules.
• Access to the Company Learning Institute, including LinkedIn Learning and leadership programs.
• Support for family-forming benefits and caregiver assistance.