Manager, Combination Product Development (Medical Devices)

Location: Hybrid role based out of the Bridgewater, New Jersey office, with remote work most of the time and in-person collaboration as needed

Salary: $124,000–$161,000 annual

Company

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

What you will do

• Analyze process and product data and generate lifecycle metrics through statistical analysis.
• Lead complaint trend and manufacturing investigations involving devices and combination products.
• Manage risk assessments, risk management files, and annual UFMEA reviews.
• Assess device and process changes, update design history files, and own related change controls.
• Coordinate technical meetings with device manufacturers and represent device impact in CMC meetings.
• Review labeling, IFU, training material changes, and draft NDA amendments for major changes.

Requirements

• Bachelor’s degree and at least five years of engineering or operations experience.
• Experience with design control, risk management, CAPA lifecycle, root cause investigations, and change control.
• Working knowledge of FDA Quality System Regulation, 21 CFR Part 820, ISO 13485:2016, ISO 14971:2007, and EU Medical Device Regulation.
• Experience with GxP systems and excellent verbal and written communication skills.
• Strong organization, attention to detail, clarity, accuracy, and conciseness.
• High proficiency in Microsoft Word, Excel, PowerPoint, and Outlook.

Nice to have

• Certified Quality Engineer or similar certification.
• Statistical expertise and experience with Minitab or other statistical tools.

Culture & Benefits

• Purpose-driven environment focused on patients, scientific progress, curiosity, and meaningful contributions.
• Occasional global travel of approximately 5%–10%.
• Medical, dental, vision, mental health, wellbeing reimbursement, and Employee Assistance Program benefits.
• Paid time off, family-forming and caregiver benefits, and flexible work schedules.
• U.S. benefits include a 401(k) plan with company match, annual equity awards, ESPP, and company-paid life and disability insurance.
• Learning programs, mentorship, employee resource groups, service programs, and networking opportunities.