Project Engineer, Development (Medical Devices)

Location: Audubon, Pennsylvania, United States

Company

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

What you will do

• Gather feedback from surgeons and customers to define functional and design specifications for new products.
• Create and maintain project plans and FDA-compliant Design History Files for assigned development projects.
• Design and develop surgical instruments and implants using Creo Parametric or similar CAD software.
• Coordinate rapid prototyping and evaluation with the internal prototype shop and external vendors.
• Perform design verification and validation activities and support regulatory applications to the FDA and other bodies.
• Partner with marketing, operations, purchasing, and sales on forecasts, manufacturing setup, product launches, and post-launch improvements.

Requirements

• Two to seven years of mechanical design engineering experience, preferably in medical devices.
• Bachelor’s degree in Mechanical Engineering or a similar field.
• Proficiency in Creo Parametric or similar CAD software for design and drafting.
• Proven leadership of people, strong initiative, organization, attention to detail, and ability to manage multiple deadlines.
• Proficiency in Microsoft Office and preparation of reports and budgets.
• Ability to travel up to 5% and attend surgeries or labs.

Culture & Benefits

• Work is guided by innovation, customer focus, teamwork, and a results-oriented approach.
• Regular compliance training and adherence to applicable United States and international regulations are required.
• The role involves occasional travel, surgeries, and laboratory attendance.
• The position includes occasional lifting and other physical activities required to perform essential duties.
• hirify.global supports an inclusive and respectful workplace and is an equal opportunity employer.