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R&D Design Engineer

2 months ago

Vista, United States Next Orthosurgical, Inc. Full time

SUMMARY:

This position is primarily responsible for generating creative designs of Spine implants and surgical instruments which are mechanically and clinically feasible, conducting tests to analyze their performance, and completing supporting FDA regulated documentation. 

 

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Core duties and responsibilities include the following. Other duties may be assigned.

·        Creates Computer Aided Design CAD models, assemblies, and drawing using Solidworks CAD system.

·        Works with Engineering team and outside supplier to ensure specifications contain proper level of detail required to provide quality product.

·        Completes Design History File (DHF) documents in accordance with ISO 13485 regulations.

·        Assists in the design and construction of test fixtures and prototypes to accomplish assigned project and testing goals.

·        Writes test protocols and reports, including test objectives and interpretation of data.

·        Support sustaining activities for existing product lines.

·        Maintains organized archive of all design concepts and files.

·        Performs dimension and tolerance analysis on part assemblies.

·        Performs in a self-directed environment to support production schedules.

·        Participates and contributes to decision-making process.

·        Provides status updates to the supervising engineer and other engineers submitting work requests.

·        Works with personnel in related areas to coordinate activities and to achieve desired results.

·        Performs projects with minimal supervision; completed work is reviewed for technical adequacy and satisfaction of requirements.

·        Participates in facilitated training and development programs designed to increase knowledge in issues related to medical device manufacturing and development, such as good manufacturing practice (GMP), Total Quality, etc., as well as their application.


EDUCATION AND/OR EXPERIENCE:

Bachelor's degree (B.S.) in Mechanical or Biomedical Engineering from four-year college or university.

1-5 years in Spine implant/ instrument development (or other orthopedics) preferred.

Master’s degree (M.S.) or higher in Mechanical or Biomedical Engineering may be substituted for years of industry experience.


COMPUTER SKILLS:

To perform this job successfully, an individual should be proficient with: Spreadsheet Software (Excel); Design Software (Solidworks); Word Processing Software (Word); Electronic Mail Software (Outlook); Presentation software (PowerPoint);

 

CERTIFICATES, LICENSES, REGISTRATIONS:

Valid driver 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).

 

OTHER QUALIFICATIONS:

Expert level Solidworks CAD modeling including: parametric modeling, design tables, linked dimensional relationships, configurations, and surfacing.

Expert level understanding of geometric dimensioning and tolerancing (GD&T).

At least three (3) years’ experience with Solidworks CAD system.

Excellent understanding of mechanical theory.

Able to work a flexible schedule to include 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.


COMPENSATION:

$90-110k annual salary

Project-based bonus incentive

Medical, Dental, Life insurance paid 100% for employee, 50% for dependents

10 days PTO/ year

5 sick days/ year