Senior Project Engineer - Mechanical (Medical Devices)

Location: Audubon, PA, United States

Company

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

What you will do

• Advance Excelsius Cranial hardware and instrumentation from concept through design, prototyping, testing, manufacturing, FDA approval, introduction, and post-introduction monitoring.
• Gather market feedback from surgeons and customers to define functional and design specifications.
• Manage assigned engineering projects, schedules, requirements, specifications, and test documentation.
• Perform design verification and validation, develop manufacturing test fixtures, and define incoming-part inspection procedures.
• Partner with manufacturing, testing teams, and customers to investigate quality issues, identify root causes, and implement corrective actions.
• Support product launches, customer interactions, complaints, CAPAs, and NCMRs.

Requirements

• At least 5 years of mechanical engineering experience.
• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or a similar field.
• Proficiency with CAD software such as CREO Parametric, Pro/E, or SolidWorks.
• Strong knowledge of mechanical systems, materials, and manufacturing methods.
• Ability to work independently and contribute effectively in small teams.
• Ability to travel up to 5% and attend surgeries and/or laboratory sessions.

Nice to have

• Medical device industry experience.
• CREO Parametric proficiency.
• Knowledge of Geometric Dimensioning & Tolerancing.
• Master’s degree in Mechanical Engineering, Biomedical Engineering, or a similar field.

Culture & Benefits

• Work in a fast-paced, hands-on product development environment.
• Collaborate with researchers, educators, surgeons, manufacturing teams, testing teams, and customers.
• Operate according to company, AdvaMed, and MedTech codes and applicable United States and international regulations.
• Values include innovation, customer focus, teamwork, and driven execution.
• Reasonable accommodations are available for individuals with disabilities.