COMPANY PROFILE:

Advanced Research Medical is a medical device manufacturer, most commonly associated with spine surgery, across the United States.

JOB SUMMARY:

The Medical Device Design Engineer will work directly with the Senior Engineer, surgeon, company management and internal manufacturing to develop medical device input guidelines for new surgical implant systems, develop prototypes and surgical instruments for rapid development of new ortho-spine systems.

DUTIES / RESPONSIBILITIES:

Responsible for creating solid models and manufacturing drawings, completing design control documents, quality system documents and creating the DHF for FDA review through the 510(k) process;

Design transfer and DMR maintenance;

Participate in anatomic test labs with surgeons;

Travel to surgical case sites to gather input from surgeons;

Travel to attend surgical events, trainings and meetings.

QUALIFICATIONS:

B.Sc. in Mechanical Engineering, Mechanical Engineering Technology, or similar technical discipline

At least 2-4 years relevant work experience with medical device design; ortho-spine experience preferred;

Working understanding of FDA 21 Code of Federal Regulations (CFR); Quality Management System (QMS) requirements, Good Documentation practices(GDP) and ISO 13485 (Certification for Medical Device Manufacturers);

Experience in the application of geometric dimensioning and tolerancing (GD&T) to drawings;

Proficient with SolidWorks; Microsoft Excel and Office;

Flexibility to work with conflicting inputs and determining a solution to satisfy user requirements;

Proficient in the design control process; knowledge of tracing design history file documents to product requirements, including design input / output / verification / validation;

Comprehensive knowledge of design history file (DHF), design transfer and device master record (DMR) application and maintenance;

Impeccable attention to detail; verbal and written communication and interpersonal skills;

Highly proficient level of computer technology and relevant industry-related software applications;

Highly proficient analytical and problem-solving skills;

Proficient time management skills and ability to work efficiently to deadlines;

Ability to work independently and within a team environment with very limited supervision;

Ability to lift at least 50 pounds in weight.

COMPENSATION:

$90K annual base salary for this full-time, exempt position, plus benefits.

LOCATION

Burnsville, MN