Manufacturing Engineer (All Levels), New Product Development

Location: Gainesville, Florida, United States; Workplace type: Onsite

Company

hirify.global develops orthopedic implants and instruments focused on improving surgical outcomes and mobility.

What you will do

• Represent Manufacturing Engineering on new product development and sustaining project teams.
• Lead Design for Manufacturability and Design for Assembly activities throughout the product lifecycle.
• Define manufacturing processes, equipment requirements, tooling, fixtures, and work instructions.
• Support process validation activities, including IQ, OQ, and PQ, with Quality Engineering.
• Support pilot builds, first-article builds, production ramp-up, supplier readiness, and product transfer.
• Identify manufacturing risks and contribute to design reviews, PFMEA, change management, and continuous improvement.

Requirements

• Bachelor’s degree in Manufacturing, Mechanical, Biomedical, Industrial, or related Engineering.
• 1–5 years of manufacturing engineering experience in a regulated environment such as medical devices, aerospace, or automotive.
• Experience supporting new product development and transfer to manufacturing.
• Demonstrated application of DFM and DFA principles to product designs.
• Knowledge of manufacturing processes, tooling, fixtures, production equipment, quality systems, validation requirements, FDA, and ISO standards.
• Ability to interpret engineering drawings, specifications, and GD&T, while managing multiple deliverables and deadlines.

Nice to have

• Experience with risk management tools such as PFMEA.
• Proficiency with CAD viewers, ERP/MRP systems, and document control tools.

Culture & Benefits

• Work in an onsite Manufacturing Engineering environment.
• Collaborate with R&D, Quality, Supply Chain, and Operations.
• Contribute to orthopedic product innovation and improvements in surgical outcomes.

Hiring process

• Initial interview.
• Hiring manager and team interviews.
• Final selection followed by an offer.