Senior Engineer

Job Summary

Join a world-class academic orthopaedic team dedicated to shaping the future of patient care through medical device innovation. You’ll collaborate with visionary clinicians, researchers, engineers, and manufacturing experts to design and translate cutting-edge technologies into real-world clinical solutions. Work in a state-of-the-art facility equipped with advanced technical resources and supported by a culture that values creativity, collaboration, and impact.

Responsibilities

• Design and develop commercial ready orthopaedic medical device systems.
  • Utilize advanced knowledge of engineering and health sciences to design orthopaedic implants, instruments, and non-surgical medical devices.
  • Conduct activities in compliance with FDA QSR’s and ISO 13485.
  • Ideate and develop concepts, develop SolidWorks CAD models and drawings, conduct engineering analyses, develop test protocols, conduct product testing, write test reports, conduct risk analyses, perform product benchmarking, develop cost of goods or cost of services, develop product packaging and container systems, develop validated product reprocessing and terminal sterilization procedures, conduct design reviews, support regulatory submissions, manage and report on projects, create design history files.
  • Oversee projects and provide part-time management of professionals.

Qualifications

• Professional Job Responsibilities:
  • Design and medical devices.
    • Utilize advanced knowledge of engineering and health sciences to design implants, surgical instruments, and other diagnostic and therapeutic devices.
    • Conduct product testing and create models and prototypes to ensure product performs as designed.
    • Determine design specifications, conduct feasibility assessments and perform failure analysis studies.
    • Create and interpret technical drawings and schematics.
    • Utilize drafting tools or computer-aided design (CAD)/drafting equipment and software in design work.
    • Manage project schedules and budgets.
    • Perform clinical and preclinical assessments.
• EQUIVALENCY STATEMENT :
  • 1 year of higher education can be substituted for 1 year of directly related work experience (Example: bachelor’s degree = 4 years of directly related work experience).
• Department may hire employee at one of the following job levels:
  • Medical Device & Equipment Engineer, III : Requires a bachelor’s (or equivalency) + 6 years or a master’s (or equivalency) + 4 years of directly related work experience.
  • Medical Device & Equipment Engineer, IV: Requires a bachelor’s (or equivalency) + 8 years or a master’s (or equivalency) + 6 years of directly related work experience.
  • Medical Device & Equipment Engineer, V: Requires a bachelor’s (or equivalency) + 10 years or a master’s (or equivalency) + 8 years of directly related work experience.

Preferences

• Multiple successes bringing biomedical devices, processes or systems from concept to actual use.
• Highly proficient in CAD model and drawing creation.
• Highly proficient in design verification and validation activities.
• Expertise in applicable anatomy and physiology.
• Expertise in multiple biomedical product / process / system areas.
• Highly proficient in applying engineering science and technology knowledge.
• Proficient use of statistical methods.
• Highly efficient in the management of resources.
• Excellent written and oral communication skills.
• Excellent project management skills.
• Effective at contributing to intellectual property portfolios.
• Depth of knowledge with applicable regulatory and quality requirements (e.g., FDA 21 CFR 820 and ISO 13485).
• Flexibility, persistence, resourcefulness, and a drive to succeed.