Senior Project Engineer (Medical Devices)

Location: Audubon, Pennsylvania, United States

Company

hirify.global develops medical technologies and surgical solutions for patients with musculoskeletal disorders, working with surgeons, researchers, and healthcare providers.

What you will do

• Lead engineering activities for spine product lines from concept and design through prototyping, development testing, verification, validation, manufacturing, FDA approval, introduction, and post-introduction monitoring.
• Gather market feedback from surgeons and customers and translate it into functional and design specifications.
• Create project plans and FDA-compliant Design History Files while managing schedules, tasks, quality-system compliance, and regulatory requirements.
• Design and develop instruments and implants using Creo, partnering with prototype shops and external vendors.
• Collaborate with marketing, product management, operations, suppliers, and manufacturing teams on forecasts, market plans, production setup, and product launches.
• Support regulatory applications, sales training, customer interactions, competitor research, and responses to post-launch change requests.

Requirements

• 7+ years of mechanical design engineering experience, preferably in medical devices.
• Bachelor’s degree in Mechanical Engineering or a related field.
• Required proficiency in Creo software for design and drafting.
• Proven people leadership, self-starting ability, strong organization, attention to detail, and effective multitasking.
• Ability to work in a fast-paced, deadline-driven environment and collaborate as part of a team.
• Proficiency in report and budget preparation and Microsoft Office.

Culture & Benefits

• Work is guided by the values of innovation, customer focus, teamwork, and drive.
• Emphasis on improving patient care through advanced medical technology.
• Commitment to ethical business practices, regulatory compliance, inclusion, and respectful collaboration.
• Full-time employment with equal employment opportunity.