Sr Project Engineer (Medical Devices)

Location: Audubon, Pennsylvania, United States

Company

hirify.global develops surgical instruments and implants designed to improve outcomes for patients with musculoskeletal disorders.

What you will do

• Lead the design and development of surgical instruments and implants using CAD software.
• Create project plans and maintain FDA-compliant Design History Files.
• Perform design verification and validation, coordinate prototyping, and support regulatory applications.
• Engage with surgeons and customers through product introductions, customer visits, sales training, and surgical-case support.
• Collaborate with marketing, product management, operations, manufacturing, quality, regulatory, and supply chain teams.
• Manage product sustaining activities, including quality issues, supply chain changes, cost improvements, engineering changes, and documentation updates.

Requirements

• Bachelor's degree in Mechanical Engineering, Bioengineering, Biomedical Engineering, or a similar field.
• 7+ years of mechanical design engineering experience; medical device experience is strongly preferred.
• Proficiency with CREO and/or SolidWorks for mechanical design, drafting, and documentation.
• Proficiency with Microsoft Excel, PowerPoint, and Project.
• Strong analytical, problem-solving, organizational, communication, and collaboration skills.
• Ability to work in engineering and clinical environments, including operating rooms and cadaver labs.

Culture & Benefits

• Work is guided by innovation, customer focus, teamwork, and a results-driven approach.
• Collaborative work with researchers, educators, surgeons, healthcare providers, and cross-functional teams.
• Inclusive and respectful workplace committed to equal employment opportunity.