Product Development Engineer (Medical Devices)

Location: On-site in Greenville, Pennsylvania, United States

Salary: $75,000–$85,000 per year

Company

hirify.global designs, manufactures, and internationally markets customizable research and clinical devices for neuroscientists, neurologists, and neurosurgeons.

What you will do

• Contribute to new product development and manufacturing of research and clinical devices across all phases of design, development, and product support.
• Develop design input requirements, product specifications, novel designs, prototypes, and verification plans.
• Review design solutions for suitability and functionality.
• Initiate and contribute to engineering changes, corrective and preventive actions, and bug reports.
• Create and maintain production drawings, assembly instructions, bills of material, and production-ready processes.
• Manage production processes to maintain and improve performance and reliability.

Requirements

• Bachelor’s degree in mechanical engineering, biomedical engineering, or a closely related field; an associate’s degree may be considered with demonstrated experience.
• 3–5 years of engineering experience.
• Technical writing experience for controlled documents, including SOPs, work instructions, and protocols.
• Experience with Microsoft Office 365, CAD software, and engineering drawings.
• Understanding of ISO 13485:2016 and related regulations.
• Hands-on experience with design controls, design verification and validation, and design and development file management.

Nice to have

• Medical device industry experience.

Culture & Benefits

• Health and dental insurance options.
• 401(k) with company match and an Employee Stock Ownership Plan.
• Generous paid time off, holiday pay, and paid sick time.
• Up to $1,000 per year for approved professional development.
• Life insurance, HSA, and DCA account options.
• Collaborative, positive, and team-focused work environment.