Product Development Engineer

Medartis Inc. - United States; Warsaw (IN); On-site; USD 85,000 - 130,000; Full time

Job summary

A leading company in the medical device industry is seeking a Product Development Engineer to design and develop new implants and instruments. This role involves direct collaboration with surgeons and cross-functional teams to ensure product compliance and manufacturability while adhering to FDA regulations. Candidates should possess a degree in engineering, strong CAD skills, and experience in medical device development.

Qualifications

• 3-5 years of experience in designing and developing mechanical products.
• Knowledge of CAD software (SolidWorks, Pro-E, etc.) preferred.
• Experience in the medical device industry desirable.

Responsibilities

• Designs and develops new implants and instrumentation.
• Works directly with surgeons for design concept development.
• Generates product models and conducts mechanical testing.

Skills

Communication

Creative Design

Problem Solving

Education

BS Biomedical Engineering

BS Mechanical Engineering

BS MET

Tools

CAD Software

Job description

Join to apply for the Product Development Engineer role at Medartis Inc. - United States

Join to apply for the Product Development Engineer role at Medartis Inc. - United States

Medartis develops, manufactures and distributes titanium screws and plates, surgical instruments and system solutions for fracture fixation. We place the highest priority on maintaining stringent quality standards, continuous further development and innovation as well as comprehensive service provision for physicians, staff and patients.

The Product Development Engineer contributes to project teams by designing and developing new implants and instrumentation. This includes communication with surgeons and sales consultants, understanding clinical issues and needs, defining design parameters, and ensuring the correct product is provided to the customer.

Your Responsibilities

• Designs and develops new implants and instrumentation and develops improvements and modifications to current products
• Interacts with surgeons, manufacturing, regulatory affairs, sales consultants, product managers, and other functional departments to define and develop product requirements and concepts
• Supports project lead and other core team members in commercialization of product.
• Works directly with surgeons for design concept development, prototype and cadaver evaluation, and clinical follow-up
• Generates product models, concept layouts, and prints using a CAD software. Apply geometric dimensioning and tolerancing accordingly
• Performs the required activities and generates the appropriate documents to ensure compliance with FDA Design Control regulations, and to support 510(k) submissions or IDE clinical studies
• Develops mechanical test protocols according to ASTM standards and coordinates the activities required to fabricate test parts and complete mechanical testing
• Works with manufacturing during the design stages to incorporate manufacturability into the product designs
• Responsible for all the designs from concept development through product launch.
• Responsible for initial patent review of designs for freedom to operate
• Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times
• Performs other special projects and functions as assigned by the department manager
• Knows basic company practices, procedures, policies and job tasks. Applies knowledge of standard concepts and principles that apply to job assignments.
• Works on a variety of problems of moderate scope and complexity. Tasks are well defined, has some latitude to determine procedures.
• Objectives and methods are predetermined. Work is closely supervised.
  
  

Your Qualifications

• 3-5 years of experience in the design and development of mechanical products
• Knowledge of CAD software (SolidWorks, Pro-E, etc.) preferred
• BS Biomedical Engineering, BS Mechanical Engineering, BS MET (or equivalent) required
• Experience in medical device industry desirable
• Strong communication and interaction skills, with the ability to interface with surgeons and sales/marketing personnel
• Demonstrated creative design ability
• Demonstrated success in developing finished design specifications
  
  

Seniority level

• Seniority level

  Entry level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Engineering and Information Technology

• Industries

  Medical Device

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