Associate Project Engineer - Mechanical (Medical Devices)

Location: Audubon, Pennsylvania, United States

Company

hirify.global develops medical technologies and products that improve surgical techniques and outcomes for patients with musculoskeletal disorders.

What you will do

• Support Excelsius Cranial hardware and instrumentation throughout the product lifecycle, from concept and prototyping through manufacturing, FDA approval, product introduction, and post-introduction monitoring.
• Gather market feedback from surgeons and customers and translate clinical needs into functional and design specifications.
• Manage assigned engineering projects and support product requirements, specifications, test documents, manufacturing fixtures, and inspection procedures.
• Perform design verification and validation activities to confirm that products meet specifications.
• Partner with manufacturing, internal testing, and external customers to investigate quality issues, identify root causes, and implement corrective plans.
• Support product launches, sales training, customer interactions, complaints, CAPAs, and NCMRs.

Requirements

• 0–2 years of mechanical engineering experience; medical device experience is beneficial.
• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or a similar program; four additional years of design experience may substitute for the degree.
• Proficiency with CAD software such as Creo Parametric, Pro/E, or SolidWorks; Creo Parametric is preferred.
• Strong understanding of mechanical systems, materials, and manufacturing methods, with familiarity with geometric dimensioning and tolerancing preferred.
• Ability to work independently and contribute effectively in small teams, with strong communication, time-management, and organizational skills.
• Ability to travel up to 5% and attend surgeries and/or laboratory sessions.

Culture & Benefits

• Work in a fast-paced, collaborative environment focused on innovation, customer needs, teamwork, and results.
• Partner with surgeons, researchers, educators, manufacturing teams, and other company functions.
• Maintain technical knowledge through educational workshops, professional publications, networks, and professional societies.
• Complete training and follow company, industry, and governmental compliance requirements in the United States and internationally.