Sr. Design Engineer

Description

Position Summary:

The Senior Design Engineer is responsible for leading the design, development, and optimization of medical devices that improve patient mobility and recovery. This role involves collaborating with cross-functional teams, including surgeons, regulatory experts, and manufacturing specialists, to ensure that implants meet clinical, biomechanical, and regulatory standards. The engineer will oversee product lifecycle management, from concept development to market launch, ensuring compliance with FDA regulations and ISO standards.

This role is considered ‘on-site’ from corporate headquarters in Brecksville, OH. 

Travel may be required to gather clinical feedback and support promotion of product line. Travel expected at 25% or more to meet the needs of the position.  

Duties and Responsibilities: 

This list is not comprehensive but meant to represent the most common or important duties of the position. Other duties are required and/or assigned:

• Lead the design and development of orthopedic implants, prosthetics, and surgical instruments.
• Conduct biomechanical research to ensure implants meet patient needs and medical standards.
• Collaborate with surgeons and medical professionals to refine designs based on clinical feedback.
• Oversee product verification and validation activities to ensure safety and effectiveness.
• Ensure compliance with FDA regulations, ISO 13485, and other medical device standards.
• Work with manufacturers and suppliers to optimize production processes.
• Investigate device failures and implement design improvements.
• Maintain design history files and documentation for regulatory submissions.

Requirements

Preferred Requirements:

• Strong knowledge of biomechanics, materials science, and CAD software, preferably SolidWorks. 
• Familiarity with FEA, experience with Abaqus software specifically a plus. 
• Experience with FDA regulations, ISO 14971 risk management, and quality assurance.
• Excellent problem-solving and communication skills.
• 5+ years of experience in medical device design, preferably in orthopedic implants.

Minimum Qualifications: 

• Bachelor’s or Master’s degree in Biomedical Engineering, Mechanical Engineering, or a related field.

Language Skills:

Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public. 

Reasoning Ability: 

Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.  Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Ability to define problems, collect data, establish facts, and draw valid conclusions.  Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. 

Certificates, Licenses, Registrations: Maintains a valid Driver’s License.  

Essential Job Functions: Critical features of this job are described below. They may be subject to change at any time due to reasonable accommodation or other reasons.   

Mental: Must be able to effectively communicate with others; complete and understand complex analysis of numbers; read, analyze and interpret written materials; develop team to meet and exceed company standards; ensure compliance with company policies; respond appropriately to feedback to make improvements; maintain positive working relationships; troubleshoot and solve problems.  

Physical: Must be able to hear and verbally communicate for hours at a time, use computer equipment. Moderate noise level and limited exposure to physical risk.  

Knowledge, Skills, and Abilities Required: Knowledge of modern business communication, office procedures and methods. Skill to use a personal computer and various software packages such as Microsoft Office Suite.  Ability to establish priorities, work independently with minimal supervision, and facilitate teamwork. Any other duties as assigned by Auxano Medical.   

Equipment Used: telephones, computer, other office equipment as needed.   

Special/ Additional Requirements: Persons in this position may be required to pass a drug, alcohol, credit, and/or criminal background check.