Sr. Design Engineer

Applied Medical Technology, Inc. (AMT); Brecksville (OH); On-site; USD 80,000 - 100,000; Full time

Benefits offered by this job

Major medical, dental, and vision insurance

Voluntary benefits including hospital indemnity

401k with company match up to 3%

Paid Time Off (PTO) from day one

Job summary

A leading company in medical equipment manufacturing seeks a Senior Design Engineer to lead the design and development of orthopedic implants. This role involves collaboration with cross-functional teams and compliance with FDA regulations. The ideal candidate will have a strong background in biomechanics and materials science, with experience in medical device design.

Qualifications

• 5+ years of experience in medical device design, preferably in orthopedic implants.
• Strong knowledge of FDA regulations and ISO 14971 risk management.

Responsibilities

• Lead the design and development of orthopedic implants and surgical instruments.
• Collaborate with surgeons to refine designs based on clinical feedback.
• Ensure compliance with FDA regulations and ISO standards.

Skills

Biomechanics

Materials Science

Problem-Solving

Communication

Education

Bachelor’s or Master’s degree in Biomedical Engineering

Mechanical Engineering

Tools

SolidWorks

Abaqus

Job description

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

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