Senior Project Engineer, Mechatronics

Location: Audubon, Pennsylvania, United States

Company

Develops medical technologies and surgical solutions for patients with musculoskeletal disorders, working with surgeons, researchers, educators, and healthcare providers.

What you will do

• Lead engineering activities from product concept through design, prototyping, development testing, verification, validation, manufacturing, FDA approval, introduction, and post-launch monitoring.
• Gather feedback from surgeons and customers to define functional and design specifications for new products.
• Create project plans and maintain compliant Design History Files while managing schedules, tasks, budgets, and reports.
• Design and develop instruments and implants using Creo, partnering with prototype shops and external vendors.
• Coordinate with marketing, product management, operations, purchasing, and manufacturing on forecasts, market plans, production setup, and product launches.
• Support regulatory submissions, sales training, customer interactions, competitor research, and post-introduction product changes.

Requirements

• At least five years of mechanical design engineering experience, preferably in medical devices or robotics.
• Bachelor’s degree in Mechanical Engineering or a similar field.
• Proficiency in Creo software for design and drafting.
• Leadership experience, strong initiative, organization, attention to detail, and the ability to manage multiple deadline-driven tasks.
• Experience preparing reports and budgets, with proficiency in Microsoft Office.
• Ability to work with customers, investors, regulatory agencies, industry peers, suppliers, and internal teams while following applicable United States and international regulations and company policies.

Nice to have

• Manufacturing experience in the endovascular field.

Culture & Benefits

• Full-time employment focused on innovation and improving patient care.
• Values include innovation, customer focus, teamwork, and decisive execution.
• Inclusive and respectful workplace committed to equal employment opportunity.
• Role includes physical activities such as sitting, climbing or balancing, stooping, kneeling, crouching, crawling, and lifting up to 25 pounds occasionally.