Careers

There’s never been a more exciting time to work with the Surefire Medical team. Join us as we invent the future for cancer care.

Current Openings

  • Evaluates manufacturing processes by collecting production process data, input from operators and equipment capability to develop process improvements.
  • Identify and characterize key equipment/process inputs required to meet medical device requirements.
  • Ability to review current manufacturing production equipment/processes and integrate improvements.
  • Ability to analyze equipment technology for the purposes of integration to current production.
  • Designs and develops manufacturing processes, tooling, and fixtures to meet production schedules while enhancing productivity and product quality.
  • Identifies, develops, and implements process improvements and strives for continuous improvements and cost reductions.
  • Evaluates, selects, installs, and conducts preventative maintenance of production equipment, troubleshoots equipment issues.
  • Responsible for all aspects of equipment and process implementation (IQ, OQ, PQ) including protocol development, execution, and operator training and report writing.
  • Incorporates statistical tools such as Gage R&R, Cpk, and SPC to improve processes.
  • Utilizes lean manufacturing concepts to improve quality, labor efficiency, and throughput.
  • Strong Protocol and report writing skills with strong statistical analysis capability.
  • Works with cross functional teams including product development to support manufacturing transfer from R&D into production
  • Support product issues at incoming inspection as well as in process issues to resolve the issues within the quality system such as non-conforming materials and CAPAs.
  • Complies with established Company and departmental policies and procedures, objectives, quality assurance program, safety and environmental standards.

Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.

 

Qualifications

 

Education & Certifications:

  • B.S. in Mechanical, Manufacturing, Chemical, or Industrial Engineer

 

Work Experience:

  • 5 year minimum medical device experience.

 

Knowledge, Skills & Abilities:

  • Solidworks 2016 or higher CAD skills.
  • Geometric Tolerancing and Dimensioning knowledge preferred.
  • Design for manufacturability of fixtures and / or equipment.
  • Strong statistical analysis.
  • Experience with medical device manufacturing process qualifications (IQ, OQ, PQ).
  • Coating experience strongly preferred.

 

Physical Requirements:

  • Ability to work under a microscope.
  • Dexterity to assemble microscopic parts.
  • Must be able to lift 40 pounds.

Job Document #:  JOB-0059

  • Work with engineering team on complex projects; independently lead projects of smaller scope.
  • Create product/equipment designs and transfer them into CAD models and drawings using SolidWorks.
  • Design, build test, and documentation of functional prototypes to demonstrate proof of concept in bench testing and animal studies.
  • Manage technical requirements with outside vendors that provide components, assemblies, manufacturing processes, testing, and other services.
  • Develop and perform design verification and design validation activities. Generate test protocols and test reports.
  • Perform characterization of equipment/processes to understand design/process capability.
  • Work with Manufacturing Engineers to develop, qualify and validate new manufacturing processes, as needed.
  • Build and validate test equipment, conduct testing of product and analyze data as needed (statistics knowledge for comparison).
  • Follow approved procedures for activities conducted and update or generate new procedures as needed.
  • Ensure that product development and manufacturing activities are performed in accordance with U.S. Quality System Regulations and ISO 13485
  • Assure individual and group safety when conducting all activities.
  • Maintain effective communications with supervisor and peers in project activities.
  • Support manufacturing activities, as necessary.

 

Qualifications

 

Education & Certifications

  • Minimum of four year mechanical engineering degree.

 

Work Experience:

  • Minimum of 5 years of Medical Device experience required.

 

Knowledge, Skills & Abilities:

  • SolidWorks 2016 or higher CAD skills.
  • Geometric Tolerancing and Dimensioning knowledge preferred.
  • Design for manufacturability of plastic and extruded components preferred.
  • Design for manufacturability and assembly of process/product development.
  • Understanding of Statistical Methods.

 

Physical Requirements:

  • Ability to work under a microscope.
  • Dexterity to assemble microscopic parts.
  • Must be able to lift 40 pounds.

 

Job Document #:  JOB-0057 R01

 

 

  • Creation of early stage medical device prototypes and devices for product evaluation.
  • Support day-to-day engineering activities.
  • Evaluate prototypes utilizing test equipment such as force testers, calipers, flow models, weight scale etc.
  • Build tools, fixtures and processes utilizing experience with common shop tools.
  • Installation, troubleshooting, and maintenance of R&D and production equipment.
  • Assist safety team to ensure compliance with applicable safety standards.
  • Follow approved procedures for activities conducted, and provide feedback to update or generate new procedures as needed.
  • Ensure that product development and manufacturing activities are performed in accordance with U.S. Quality System Regulations and ISO 13485
  • Maintain effective communications with supervisor and peers in project activities.
  • Ensure lab and shop area remain clean and orderly.

 

Qualifications

 

Education & Certifications

  • Associates degree within a technical field

 

Work Experience:

  • Minimum of 2 years working in a lab or medical device environment is required.

 

Knowledge, Skills & Abilities:

  • Mechanical aptitude
  • Experience with physical and mechanical testing.  ISO and ASTM testing experience preferred.
  • Ability to read and interpret engineering drawings
  • Basic knowledge/capability of SolidWorks is preferred.

 

Physical Requirements:

  • Ability to work under a microscope.
  • Dexterity to assemble microscopic parts.
  • Must be able to lift 40 pounds.

 

Job Document #: JOB-0056 R01