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Design Engineer - Innovative Medical Device Solutions

Atec SpineCarlsbad, California, United States
On-site Full-time $75K/yr - $90K/yr

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Experience Level

Experience

Qualifications

The following qualifications represent the knowledge, skills, and abilities necessary to succeed in this role. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. Proficient in 3D CAD software, particularly SolidWorks. Excellent verbal and written communication skills; confident in presenting to senior management. Familiarity with geometric dimensioning and tolerancing is preferred. Prior experience in a manufacturing environment, with a focus on metals and plastics, is advantageous.

About the job

Join our dynamic sustaining team as a Design Engineer, where you will play a pivotal role in enhancing existing products. Your expertise in 3D CAD software will be critical as you create innovative concepts and detailed modeling and drafting designs. Your responsibilities will encompass drafting design history file documents, developing comprehensive test plans to evaluate designs, and collaborating across teams to ensure seamless Manufacturing, Quality Control, Regulatory, and Planning processes for your projects.

Key Responsibilities

  • Utilize SolidWorks to design and develop cutting-edge implants and instruments.
  • Contribute to new product development and manufacturing process improvements as an integral member of the development team.
  • Assist in the creation of working models for design evaluation purposes.
  • Develop protocols for testing and analyzing both new and existing products.
  • Prepare design assurance documentation for the project’s Design History File (DHF).
  • Collaborate on the development of inspection methodologies.
  • Propose design changes to optimize manufacturability while preserving essential features for both in-house and vendor manufacturing.
  • Engage with cross-functional product development teams to guide new product development from conception through to launch.
  • Support Project Engineers in providing technical insights for marketing collateral development.
  • Assist Project Engineers in conveying design functions to Marketing and Sales teams.
  • Provide technical expertise to Regulatory Affairs to assist with FDA 510(k) submissions and international registrations.
  • Generate and process Change Orders (COs).
  • Perform other duties as assigned.

About Atec Spine

Atec Spine is a leader in the development of innovative spinal surgical solutions. Our dedication to advancing medical technology is matched only by our commitment to improving patient outcomes. We foster a collaborative and dynamic work environment where every team member is valued and empowered to contribute to our mission of enhancing spinal health.

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