Manufacturing/QA Engineer (Medtech)

TL;DR

Manufacturing/QA Engineer (Medtech): Developing, validating, and supporting manufacturing processes and controls for electro-mechanical medical devices with an accent on Lean/Six-Sigma and regulatory compliance. Focus on optimizing process flow, ensuring high process capability (Cpk), and implementing production testing methods to improve patient outcomes.

Location: Onsite in Pittsburgh, PA

Salary: $80,000 - $100,000

Company

hirify.global provides innovative technologies and medical devices used worldwide to diagnose and treat critical cardiopulmonary and respiratory conditions.

What you will do

• Develop, validate, and support manufacturing processes and equipment to ensure electro-mechanical products meet strict specifications and regulations.
• Implement and manage value improvement projects using Lean/Six-Sigma methodologies.
• Establish robust manufacturing standards and process controls to ensure compliance with medical device legal requirements.
• Perform quality analyses, including Gage R&R and Cpk, to proactively identify and resolve potential problems.
• Design sequences of operations and facility layouts to optimize the utilization of production personnel and equipment.
• Support the launch of manufacturing and service processes globally, involving up to 10% international travel.

Requirements

• Bachelor's degree in Manufacturing, Industrial, Electrical, Mechanical Engineering or a related discipline.
• 5 to 8 years of relevant experience in electro-mechanical process development and quality assurance.
• Must be based in or work onsite in Pittsburgh, PA.
• Proven record of achievement in establishing robust processes and controls.
• Willingness and ability to travel internationally up to 10%.

Culture & Benefits

• Mission-driven environment focused on saving lives and improving patient outcomes.
• Culture that values innovation, self-motivation, and an entrepreneurial spirit.
• Comprehensive benefits plans.
• Opportunity to work within a fast-growing global company operating in over 140 countries.