Project Engineer (Medical Devices)

Location: Audubon, PA, United States

Company

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

What you will do

• Lead the design and development of surgical instruments and implants using CAD software.
• Create project plans and FDA-compliant Design History Files, and manage projects through commercialization in compliance with quality and regulatory requirements.
• Perform design verification and validation, support prototyping with internal shops and external vendors, and assist with FDA and other regulatory applications.
• Engage surgeons and customers through market feedback, product introductions, customer visits, sales training, and operating-room surgical case support.
• Collaborate with marketing, product management, operations, Quality, Regulatory, Manufacturing, and Supply Chain teams on forecasts, manufacturing, purchasing, and engineering changes.
• Support product lifecycle management by addressing quality and supply-chain issues, cost improvements, documentation revisions, and customer-driven product updates.

Requirements

• Bachelor’s degree in Mechanical Engineering, Bioengineering, Biomedical Engineering, or a similar field.
• At least 3 years of mechanical design engineering experience; medical device experience is strongly preferred.
• Proficiency in CREO and/or SolidWorks for mechanical design, drafting, and documentation.
• Proficiency with CAD software, preferably CREO or SolidWorks.
• Proficiency with Microsoft Excel, PowerPoint, and Project for data analysis, presentations, and project tracking.
• Strong organization, attention to detail, teamwork, analytical thinking, problem-solving, and communication skills.
• Ability to work in deadline-driven engineering and clinical environments, including operating rooms and cadaver labs.
• Ability to meet physical requirements including sitting, climbing or balancing, stooping, kneeling, crouching, crawling, lifting up to 10 pounds regularly and up to 25 pounds occasionally, and using close, distance, color, peripheral, and depth vision.

Culture & Benefits

• Values innovation, customer focus, teamwork, and decisive, results-oriented work.
• Requires compliance with company policies, the AdvaMed Code, the MedTech Code, and applicable United States and international laws and regulations.
• Provides reasonable accommodations to enable individuals with disabilities to perform essential functions.
• Operates as an equal opportunity employer committed to an inclusive and respectful workplace.