Senior Project Engineer, Biomaterials (Medical Devices)

Location: Audubon, Pennsylvania, United States

Company

hirify.global develops medical technologies and surgical solutions for patients with musculoskeletal disorders.

What you will do

• Lead engineering activities across the product lifecycle, from concept and prototyping through design testing, manufacturing, FDA approval, product introduction, and post-market monitoring.
• Gather feedback from surgeons and customers and translate it into product specifications and development plans.
• Design and develop biomaterials-based instruments and implants involving tissue engineering, drug delivery, hydrogels, scaffolds, coatings, and porous materials.
• Plan experiments, conduct in vivo testing, analyze data, troubleshoot protocols, document results, and communicate findings.
• Manage project plans, design history files, verification and validation activities, budgets, and regulatory submissions.
• Collaborate with surgeons, marketing, product management, operations, regulatory teams, and sales through manufacturing setup and product launch.

Requirements

• At least five years of engineering experience, preferably in medical devices.
• Master’s degree in biomedical engineering or a related life sciences field.
• Hands-on experience developing biomaterials, including hydrogels, scaffolds, coatings, porous materials, or tissue-interfacing materials.
• Experience with in vivo biomaterials testing for tissue regeneration, wound healing, implants, injectable materials, drug delivery, or regenerative medicine.
• Proven people leadership, strong self-starting skills, organization, attention to detail, multitasking, and ability to work to deadlines.
• Proficiency in report and budget preparation and Microsoft Office.

Culture & Benefits

• Work guided by innovation, customer focus, teamwork, and driven execution.
• Collaborate with researchers, educators, surgeons, healthcare providers, customers, suppliers, and regulatory agencies.
• Maintain compliance with the company quality system, FDA and other regulatory requirements, applicable laws, and industry codes.
• Reasonable accommodations are available for employees with disabilities.
• Inclusive equal employment opportunity environment with support for a diverse and respectful workforce.