Project Engineer - Mechanical (Medical Devices)

Location: Audubon, Pennsylvania, United States

Company

hirify.global develops medical technologies and surgical solutions designed to improve outcomes for patients with musculoskeletal disorders.

What you will do

• Develop Excelsius Cranial hardware and instrumentation from concept and prototyping through verification, validation, manufacturing, FDA approval, product introduction, and post-launch monitoring.
• Gather feedback from surgeons and customers and translate it into functional requirements, design specifications, and test documentation.
• Manage assigned engineering projects while maintaining compliance with the quality system and applicable regulations.
• Design manufacturing test fixtures, inspection procedures, and supporting documentation.
• Investigate quality issues, complaints, CAPAs, and NCMRs; identify root causes and implement corrective plans.
• Support product launches through sales training, customer calls, visits, surgeries, and laboratory activities.

Requirements

• 3–5 years of mechanical engineering experience; medical device experience is beneficial.
• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or a similar field, or four additional years of design experience in lieu of a degree.
• 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 to small teams, with strong communication, time-management, and organizational skills.
• Ability to travel up to 5% and attend surgeries and/or laboratory sessions.

Nice to have

• Advanced proficiency in Creo Parametric.
• Knowledge of Geometric Dimensioning & Tolerancing.
• Experience in the medical device industry.
• Master’s degree in Mechanical Engineering, Biomedical Engineering, or a similar field.

Culture & Benefits

• Work is guided by innovation, customer focus, teamwork, and results-driven execution.
• Collaboration with researchers, educators, surgeons, healthcare providers, manufacturing teams, and external customers.
• Professional development through workshops, publications, professional networks, and industry societies.
• Commitment to ethical conduct, regulatory compliance, inclusion, and equal employment opportunity.
• Physical activities may include occasional climbing, kneeling, crouching, crawling, and lifting up to 25 pounds.