Project Engineer (Medical Devices)

Location: Audubon, Pennsylvania, United States; full-time, onsite role involving work in operating rooms and cadaver labs.

Company

Medical device company developing surgical instruments and implants to improve outcomes for patients with musculoskeletal disorders.

What you will do

• Lead the design and development of surgical instruments and implants using CREO or other CAD tools.
• Manage projects from concept through commercialization, including plans, design history files, prototyping, and regulatory documentation.
• Perform design verification and validation activities and support FDA and other regulatory submissions.
• Gather feedback from surgeons and customers through product introductions, customer visits, and operating-room support.
• Collaborate with Marketing, Product Management, Operations, Quality, Regulatory, Manufacturing, and Supply Chain teams.
• Support commercialized products through lifecycle management, quality improvements, supply chain changes, and engineering updates.

Requirements

• Bachelor’s degree in Mechanical Engineering, Bioengineering, Biomedical Engineering, or a related field.
• At least 3 years of mechanical design engineering experience; medical device experience is strongly preferred.
• Proficiency with CREO and/or SolidWorks and mechanical design documentation.
• Proficiency with Microsoft Excel, PowerPoint, and Project.
• Strong analytical, problem-solving, communication, organizational, and collaboration skills.
• Ability to work in engineering and clinical environments, including operating rooms and cadaver labs.

Culture & Benefits

• Culture centered on innovation, customer focus, teamwork, and drive.
• Inclusive and respectful work environment with equal employment opportunity.
• Work includes collaboration with researchers, educators, surgeons, healthcare providers, vendors, and internal teams.
• Compliance with company, medical technology, and governmental regulations is required.