S
Surgentec

Quality Engineer

We have an immediate opening for a Quality Engineer at our Boca Raton, Florida facility.

SurGenTec is an innovative medical device company based out of Boca Raton, FL with a team of driven individuals on a mission to improve healthcare. Our diverse array of products offer benefits to patients, hospital staff and surgeons across many fields of medicine. We are growing quickly and are looking for a driven quality engineer to join our team. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status. Surgentec is an EO employer – M/F/Veteran/Disability.

Local candidates only- South Florida (Relocation fees will not be covered)

Job Summary

The Quality Engineer uses their personal experience and judgment applying learned engineering methodologies and other analytics to initiate, implement, and manage the master validation plan within the facility. This position will also be heavily involved in the design and development of medical devices, device accessories and processes that complement our current product lines. The hire will be working closely with our mechanical engineer to develop and maintain the design history file of our products. The hire will have responsibility for improving the product development process, operational effectiveness and existing procedures or business processes. The Quality Engineer will be a key resource for new product and equipment validations providing subject matter expertise. This position may also involve training engineers, sales representatives, vendors, manufacturers, customers, etc., to processes and principles associated with the technology, as well as providing ongoing technical support.

Job Description

  • Creates, manages, and improves the Master Validation Plan; designs protocols that utilize proper sampling techniques, strong design of experiments and tests and will provide statistical rationale.
  • Aid in the development and maintenance of design history files.
  • Conducts validation or qualification tests on new or existing equipment, processes, or software in accordance with internal protocols or external standards.
  • Works with contract testing facilities to plan and execute validations in accordance with internal protocols and external standards. These validations include sterilization, aging studies, biocompatibility, mechanical testing and packaging.
  • Aid in engineering activities for design, development, and manufacturing of orthopedic instruments to ensure a high level of process and product quality.
  • Participate in the development and improvement of manufacturing, distribution and/or other processes for existing and new products.
  • Assist in the development and upkeep of our quality management system, design history file and design history record.
  • Assist in day to day operational tasks such as receiving inspections and creating shipping documentation.
  • Review and improve product drawings.
  • Sourcing materials, instruments, packaging, etc.
  • The Engineer will have responsibility for coordination of all technical activities on assigned projects. Regular communication will be expected with cross functional team members, and manufacturers.
  • Use established procedures to improve existing medical devices and accessories. Continually optimize manufacturing procedures to produce less expensive, higher quality medical devices.
  • Assist in the resolution, documentation, customer responses of product complaints.
  • Coordinate and assist in corrective and preventative action activities and solutions
  • Comply with appropriate regulatory agencies (i.e. GMP, ISO, FDA, etc.) and associated quality systems described in PMT’s documentation.
  • Communicate with strategic vendors and suppliers.

Minimum Qualifications

· 4yr degree in applicable field of study, preferably engineering (ME, BioMedE)

· 2+ Years experience in medical device industry

· Working knowledge of 3D CAD software, in particular SolidWorks.

· United States Work Authorization

· Understanding of general manufacturing principles, machining techniques and molding processes.

· Demonstrate problem-solving and troubleshooting skills

· Demonstrate interpersonal and communication skills.

· Demonstrate a driven and positive approach to work.

· Demonstrate an ability to multi-task and learn quickly.

· Demonstrated ability to respond to the urgent needs of the team, with proven track record of meeting deadlines.

Additional Information

· Full Time

· Benefits: Health Insurance & Paid Time Off

· Schedule: Monday-Friday 9AM-5:30PM (8 hour shift)

· Location: Headquarters, Boca Raton. No remote work.

Job Type: Full-time

Pay: $65,000.00 - $80,000.00 per year

Benefits:

  • Health Insurance
  • Paid Time Off

Schedule:

  • Monday to Friday

Experience:

  • Quality Engineer: 2 years (Required)
  • Medical Devices: 2 years (Required)

Education:

  • Bachelor's (Required)

This Company Describes Its Culture as:

  • Detail-oriented -- quality and precision-focused
  • Innovative -- innovative and risk-taking
  • Outcome-oriented -- results-focused with strong performance culture
  • People-oriented -- supportive and fairness-focused
  • Team-oriented -- cooperative and collaborative

Company's website:

  • www.surgentec.com

Work Remotely:

  • No

Please mention that you come from TestForThem when applying for this job.

Posted 2 months ago

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