R&D Design Engineer

4 days ago

Vista, California, United States Next Orthosurgical, Inc. Full time
Job Summary

This is a challenging and rewarding role for a skilled R&D Design Engineer to join our team at Next Orthosurgical, Inc. as a key member of our Spine Implant and Instrument Development team.

Key Responsibilities
  • Design and develop innovative Spine implant and instrument solutions using Solidworks CAD system.
  • Collaborate with cross-functional teams, including Engineering and outside suppliers, to ensure specifications meet quality and regulatory requirements.
  • Prepare and maintain Design History File (DHF) documents in accordance with ISO 13485 regulations.
  • Assist in the design and construction of test fixtures and prototypes to achieve project and testing goals.
  • Develop and execute test protocols and reports, including test objectives and data interpretation.
  • Support sustaining activities for existing product lines.
  • Maintain organized archives of design concepts and files.
  • Perform dimension and tolerance analysis on part assemblies.
  • Work independently to support production schedules and participate in decision-making processes.
  • Provide regular status updates to supervising engineers and other team members.
  • Coordinate activities with personnel in related areas to achieve desired results.
  • Participate in training and development programs to increase knowledge in medical device manufacturing and development.
Requirements
  • Bachelor's degree in Mechanical or Biomedical Engineering from a four-year college or university.
  • 1-5 years of experience in Spine implant/instrument development (or other orthopedics) preferred.
  • Master's degree or higher in Mechanical or Biomedical Engineering may be substituted for years of industry experience.
  • Proficiency with Solidworks CAD system, Excel, Word, Outlook, PowerPoint, and other relevant software.
  • Valid driver's license and acceptable motor vehicle record.
  • Solidworks training certificate recommended (or previous working experience).
  • Geometric Dimensioning and Tolerancing (GD&T) training certificate recommended (or previous working experience).
Preferred Qualifications
  • Expert-level Solidworks CAD modeling skills, including parametric modeling, design tables, linked dimensional relationships, configurations, and surfacing.
  • Expert-level understanding of geometric dimensioning and tolerancing (GD&T).
  • At least three years' experience with Solidworks CAD system.
  • Excellent understanding of mechanical theory.
  • Able to work a flexible schedule, including weekends and holidays.
  • May require some travel on an as-needed basis.
Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

While performing the duties of this job, the employee is regularly required to sit; use hands to push, handle, or touch; reach with hands and arms; lift up to 50 lbs; talk and hear. The employee is occasionally required to stand and walk.

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The noise level in the work environment is usually moderate.

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