Senior Process Development Engineer (Medtech)

TL;DR

Senior Process Development Engineer (Medtech): Leading the development, optimization, and validation of medical device manufacturing processes with an accent on design transfer from R&D to commercial production. Focus on ensuring process robustness, regulatory compliance (FDA/ISO), and driving continuous improvement initiatives in a regulated environment.

Location: Must be based in Wayne, NJ, USA (Hybrid: 1-2 days remote per week).

Salary: $115,000–$135,000 per year.

Company

hirify.global is a global provider of innovative medical technology solutions for intensive care, cardiovascular procedures, and operating rooms, dedicated to making life-saving technology accessible.

What you will do

• Lead technical strategies for process development, characterization, and validation (IQ/OQ/PQ).
• Manage design transfer activities from R&D to manufacturing to ensure commercial readiness.
• Apply DFSS tools and statistical methods to improve process performance and robustness.
• Collaborate cross-functionally to enhance throughput, reduce scrap, and optimize manufacturing capacity.
• Conduct risk management activities including FMEA and hazard analysis.
• Mentor junior engineers and technicians while acting as a core team member.

Requirements

• Bachelor’s or Master’s degree in Mechanical, Biomedical Engineering, or a related technical field.
• 5–7 years of experience in process development and design transfer within the medical device industry.
• Six Sigma Black Belt or Green Belt certification.
• Hands-on experience with process validation, risk management, and statistical analysis.
• Proficiency in CAD tools (SolidWorks, Creo) and GD&T.
• Knowledge of regulatory standards including FDA 21 CFR Part 820 and ISO 13485.

Culture & Benefits

• Comprehensive health, dental, and vision insurance.
• 401k plan with company match.
• Paid Time Off and parental/caregiver leave.
• Tuition reimbursement program.
• Wellness initiatives and health assistance resources.
• Short and long-term disability benefits.