Sr. Design Engineer

Join to apply for the Sr. Design Engineer role at Applied Medical Technology, Inc. (AMT) 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. Description 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 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. Additional Sections (Language Skills, Reasoning Ability, etc.) These sections are detailed but contain relevant information about skills, certifications, and physical/mental requirements. Benefits and Perks Insurance: Major medical, dental, and vision insurance. Other Benefits: Voluntary benefits including hospital indemnity, critical illness, and long-term disability. 401k: Company match up to 3% of salary. Paid Time Off (PTO): Starting from day one, in addition to holidays. Additional Information Seniority level: Mid-Senior level Employment type: Full-time Job function: Engineering and Information Technology Industries: Medical Equipment Manufacturing Referrals can double your chances of interviewing. Sign in to set job alerts for similar roles. #J-18808-Ljbffr