Sr. Engineer, Production

TL;DR

Sr. Engineer, Production (Manufacturing): Lead projects in process and product improvements including cost reduction, investigate production issues and customer complaints, ensure FDA compliance, and assist in new product transfers to manufacturing with an accent on process development and validations. Focus on developing production documentation, mentoring engineers, supporting audits, and implementing corrective actions.

Wayne, NJ, US. Hybrid: 1-2 days remote per week (site-based).

$113,000 - $125,000 annually +10% bonus target

Company

hirify.global provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows in intensive care, cardiovascular procedures, operating rooms, sterile reprocessing, and life science.

What you will do

• Lead process and product improvement projects, including cost reductions.
• Investigate and respond to production issues and customer complaints.
• Mentor lower-level engineers and provide technical guidance on projects.
• Develop and execute process validations (IQ/OQ/PQ) and maintain production documentation like procedures, routers, and BOMs.
• Support complaint investigations, FDA audits, and regulatory compliance.
• Lead design changes, CAPA, and non-conformance resolutions.

Requirements

• Bachelor of Science in Mechanical, Manufacturing, or Biomedical Engineering with 5+ years in manufacturing and engineering.
• Strong technical and analytical skills.
• Experience with project management, process development, and validations.
• Proficiency in Microsoft Office and statistical analysis including DOE.
• Knowledge of Lean Manufacturing, Six Sigma, GMPs, and FDA regulations.
• Effective communication, interpersonal skills, and teamwork.

Culture & Benefits

• Comprehensive health, dental, and vision insurance.
• 401k with company match, life insurance, short/long-term disability.
• Paid Time Off, parental and caregiver leave, tuition reimbursement.
• Wellness initiatives, health assistance resources, commuter benefits.
• Health and dependent care flexible spending accounts.