Senior Project Engineer (Medical Devices)

Location: Audubon, Pennsylvania, United States; onsite

Company

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

What you will do

• Lead engineering activities across product lines from concept and design through prototyping, development testing, design verification and validation, manufacturing, FDA approval, product introduction, and post-introduction monitoring.
• Gather feedback from spine surgeons and other customers and translate it into functional and design specifications.
• Create and maintain 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, and coordinate rapid prototyping with the internal prototype shop and external vendors.
• Collaborate with marketing, product management, operations, purchasing, manufacturing, sales, and customers on forecasts, market plans, production setup, training, and product introductions.
• Support FDA and other regulatory submissions, competitor research, and post-introduction customer change requests.

Requirements

• At least five years of mechanical design engineering experience, preferably in the medical device field.
• Bachelor’s degree in Mechanical Engineering or a similar field.
• Required proficiency in Creo software for design and drafting.
• Proven ability to lead people and demonstrate strong self-starting skills.
• Ability to work in a fast-paced, deadline-driven environment and manage multiple tasks.
• Strong organization, attention to detail, and teamwork skills.
• Ability to represent the company’s philosophy to customers, investors, regulatory agencies, and industry peers.
• Proficiency in preparing reports and budgets, as well as Microsoft Office.

Culture & Benefits

• Full-time employment focused on innovation and improving patient care.
• Customer-focused, collaborative, driven, and results-oriented working environment.
• Commitment to respectful, inclusive, and diverse workplace practices.
• Expectation of compliance with company policies, the AdvaMed and MedTech Codes, and applicable United States and international laws and regulations.
• Reasonable accommodations may be provided for qualified individuals with disabilities.