Manufacturing Engineer (Medtech)

TL;DR

Manufacturing Engineer (Medtech): Representing Manufacturing Engineering throughout the product development lifecycle with an accent on ensuring product designs are manufacturable, scalable, and compliant. Focus on defining manufacturing processes, equipment requirements, and supporting process validation activities.

Location: Onsite in Gainesville, FL

Company

hirify.global focuses on innovation in orthopedic implants and instruments to optimize the surgical experience and improve patient outcomes.

What you will do

• Act as the manufacturing engineering representative on new product development and sustaining project teams.
• Lead and influence Design for Manufacturability (DFM) and Design for Assembly (DFA) activities.
• Define and document manufacturing processes, equipment requirements, tooling, fixtures, and work instructions for new products.
• Support process validation activities (IQ/OQ/PQ) in collaboration with Quality Engineering.
• Provide technical support during design reviews, risk assessments (e.g., PFMEA), and change management activities.
• Contribute to continuous improvement initiatives related to manufacturing efficiency, quality, and cost.

Requirements

• Bachelor’s degree in Engineering (Manufacturing, Mechanical, Biomedical, Industrial, or related field) required.
• Minimum 1-5 years experience in manufacturing engineering within a regulated environment (medical device, aerospace, automotive, or similar).
• Experience supporting new product development and product transfer to manufacturing.
• Demonstrated experience applying DFM/DFA principles to product designs.
• Working knowledge of quality systems, validation requirements, and regulatory standards (e.g., FDA, ISO).
• Ability to interpret engineering drawings, specifications, and GD&T.

Nice to have

• Experience with risk management tools such as PFMEA preferred.
• Proficiency with standard engineering and documentation tools (e.g., CAD viewers, ERP/MRP, document control systems).

Culture & Benefits

• Focused on innovation in orthopedic implants and instruments.