Sr. Design Engineer

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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.

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.

• 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.

• Strong knowledge of biomechanics, materials science, and CAD software, preferably Solid Works.
• 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.

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

These sections are detailed but contain relevant information about skills, certifications, and physical/mental requirements.

• 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.

• Seniority level:
  Mid-Senior level
• Employment type:
  
  Full-time
• Job function:
  Engineering and Information Technology
• Industries:
  Medical Equipment Manufacturing

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