Sr. Reliability Engineer

TL;DR

Sr. Reliability Engineer: Owns and maintains post-market quality and safety reporting for hirify.global Aortic products with an accent on PSURs, clinical evaluation updates, and field complaint trend analysis. Focus on root-cause investigations, CAPAs/NCMRs support, regulatory query responses, and quality review of change orders to improve post-market processes and support audits.

Location: Santa Ana, California, United States of America

Salary: $107,200.00 - $160,800.00 (USD)

Company

hirify.global is a global healthcare technology company focused on solving challenging health problems.

What you will do

• Own and maintain periodic safety update reports (PSURs) for hirify.global Aortic products in collaboration with Medical Safety, Regulatory, and Clinical teams.
• Support clinical evaluation updates for Aortic products and act as a quality reviewer on change orders for released products.
• Collaborate weekly with cross-functional teams (customer quality experience management, clinical affairs, medical safety, R&D, supplier quality, and manufacturing) to understand product complaints and assess field trends.
• Support investigations by working with customer quality experience management, Returned Goods Investigation, and manufacturing; update product codes and assist in investigations.
• Improve post-market processes and systems to increase team performance and productivity.
• Assist with root cause investigations for CAPAs and NCMRs, perform monthly complaint data trending, evaluate negative trends and risk to released products, and support regulatory query responses and audits.

Requirements

• Bachelor’s degree in engineering with minimum 4 years of work experience in Engineering/Science, or advanced degree in engineering/science/technical discipline with minimum 2 years of work experience, or PhD with 0 years relevant experience.
• For U.S. degrees earned outside the United States, a degree that satisfies 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
• U.S. work authorization requirements: unrestricted U.S. work authorization at hire and for duration of employment unless the role is Principal-level or above (H-1B/TN/J sponsorship is offered exclusively for Principal-level roles and above).

Nice to have

• Advanced degree in engineering/science or equivalent technical discipline.
• Demonstrated understanding of cardiovascular/implant procedures.
• Experience in a highly regulated industry, preferably medical devices in quality engineering.

Culture & Benefits

• Eligible for a short-term incentive called the hirify.global Incentive Plan (MIP).
• Benefits for regular employees working 20+ hours/week include health, dental, vision, HSA, healthcare FSA, life insurance, long-term disability, dependent daycare spending account, tuition assistance/reimbursement, and Simple Steps (global well-being program).
• Benefits for all regular employees include 401(k) with employer contribution and match, paid time off, paid holidays, employee stock purchase plan, and employee assistance program.
• 401(k) and other retirement-related plans available depending on eligibility (including non-qualified retirement plan supplement for eligible roles).

Hiring process

• Application review against minimum requirements shown on the resume.
• Interviews and evaluation of fit for quality engineering and regulated medical device responsibilities.