Senior Mechanical Engineer (MedTech)

Location: Audubon, Pennsylvania, United States

Company

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

What you will do

• Lead mechanical design and development for new product introduction and sustaining projects.
• Develop advanced designs using CAD, SolidWorks, and rapid prototyping equipment for traditional, novel, and additive manufacturing.
• Coordinate with suppliers, Supply Chain, Manufacturing, Regulatory, and Quality to manage development, production, commercialization, timelines, and cost optimization.
• Create and maintain design control documentation, requirements, specifications, risk management files, FMEAs, and design history file materials.
• Work with surgeons and operating-room staff to understand user needs and support cadaver labs, surgeon evaluations, and education events.
• Participate in feasibility studies, project planning, phase reviews, audits, and manufacturing partner oversight.

Requirements

• 5–7 years of related experience.
• Bachelor’s or advanced degree in Mechanical Engineering, Biomedical Engineering, or a related technical discipline.
• Proficiency with CAD and SolidWorks, with experience in technical and business report writing.
• Strong knowledge of manufacturing processes, design for manufacturing, geometric tolerances, and tolerance analysis.
• Experience applying FDA and state regulations and standards including ISO 13585 and IEC 60601.
• Previous medical device experience; spine or orthopedics experience is preferred.

Culture & Benefits

• Work is guided by innovation, customer focus, teamwork, and results-oriented execution.
• Commitment to improving patient care through advanced medical technology.
• Inclusive and respectful workplace with equal employment opportunity.
• Role includes physical activities such as sitting, climbing, balancing, kneeling, crouching, crawling, and lifting up to 25 pounds occasionally.