We are always on the lookout for talented individuals who share our passion.

Blue Belt Technologies is a small but diverse company who draws strength from the creative and intellectual powers of our employees. We know that in order to bring innovation into standard healthcare practice we need to grow and cultivate team members who are passionate individually, and as a group, about their work. The backbone of our company is made up of individuals pushing technical boundaries in medical product design, engineering and robotics; talents who can work efficiently in the proper regulatory and quality frameworks; and customer facing gurus committed to providing a seamless experience with our technology.

We’d like to hear your story. Please share your resume and cover letter:
info@dareent.com

Title: Clinical Specialist I
Reports To: Director of Marketing and Clinical Services
Location: San Francisco, CA
Travel: Up to 75%

Position Summary:
The Clinical Specialist I will support clinical cases as well as account-support activities working with territory Clinical Account Managers. The CS will develop clinical competency in the Navio™ assisted partial knee replacement procedures. Primary responsibility will be to support the clinical case coverage workload of the Clinical Account Managers when needed across the US. Secondary responsibilities will be in supporting Blue Belt Technologies’ clinical training and pre-sales demo programs.

Primary Responsibilities:
+ Develop competence in the company’s technology, in order to assist surgeons with system function, implant placement, and precision bone preparation as needed during surgery.
+ Provide support for in-service training to nursing staff, sterile processing, and biomed departments within a Blue Belt account.
+ During case coverage, for any disposable or implantable products consumed during surgery, obtain hospital PO for company billing.
+ Provide case reports and track metrics for Product Marketing to review. Including direct and observed customer feedback, activities performed and suggestions for product, methods, or training improvement.
+ Work tirelessly for the customer to provide confident, responsive service.
+ Ability to work with biohazards, human tissue specimen and handling.

Key Skills:
+ Bachelor’s degree in biology, biomedical engineering, engineering or similar
+ Ability to learn new technology and skills quickly.
+ Ability to communicate and teach skills to end users.
+ Ability to communicate effectively with company and management.
+ Excellent and professional interpersonal skills.
+ Ability to operate basic PC functions and software including Microsoft office suite.
+ Must have a current driver’s license.
+ Must be able to travel domestic up to 75%.


Title: Safety and Reliability Design Assurance Engineer
Location: Pittsburgh, PA

Overview:
As a Safety and Reliability Design Assurance Engineer, you will be responsible for development and execution of test plans, verifying product functionality as defined in the Design and Requirements specifications and testing product to evaluate reliability. You will have a high level of interaction with development engineers, reviewing product design for safety and reliability. You will lead test activities demonstrating that product systems operate in conformance with industry safety standards and demonstrating repetitive use capabilities of system components. You will coordinate testing to applicable industry standards.

Qualifications:
+ Bachelor’s degree or higher in engineering or related field
+ Reliability testing experience for electro-mechanical systems
+ Experience testing product designs to safety standards in a regulated industry
+ Excellent analytical problem solving and organizational skills
+ Ability to communicate with systems users and present results of tests and experiments in text, tabular and graphic form.
+ Ability to write test plans and reports
+ Experience in developing and executing manual and automated test suites
+ Familiarity with QA tools and techniques, including bug tracking systems, test design and execution
+ Working knowledge of some or all of the following quality assurance methods: Highly Accelerated + Stress Testing, Highly Accelerated Life Testing, automated testing techniques for repetitive motion and component wear testing.

Optional:
+ Medical device development experience
+ Familiarity with standards for product design, development and testing such as, IEC 60601 series, + ISO/IEC 14971:2012, IEC 62366, and ASTM series for specific materials and applications.


Title: Software Development Engineer
Location: Pittsburgh, PA

Overview:
The Software Development Engineer responsibilities will include for developing software and designing and performing experimental tests toward commercialization of the next generation of devices for computer-assisted surgery.

Experience:
+ Master’s Degree or beyond, or equivalent experience
+ Experience in design and implementation of FDA-compliant medical device software systems
+ Experience/expertise in computer vision/image processing algorithms
+ Experience with user interface toolkits
+ Experience with programming for Microsoft Windows
+ Experience programming for time-critical/real-time applications
+ Expertise in applied Linear Algebra concepts
+ Experience using data-analysis tools such as Matlab.
+ Experience using and programming for position tracking systems
+ Knowledge of mechanical design and/or machine shop experience
+ Experience with 3D modeling or CAD software
+ Business development expertise either through coursework or industry experience

Background:
+ Bachelor’s degree in computer science or related field
+ Three or more years’ experience developing/working with large-scale C++ projects
+ Demonstrated programming experience with the OpenGL graphics library
+ Familiarity with Unix/Linux operating system
+ Understanding of 3D geometric concepts such as rotation matrices and coordinate transforms
+ Excellent analytical, problem solving and organizational skills
+ Ability to communicate with systems users and present results of tests and experiments in text, tabular and graphic form
+ Excellent organizational, documentation and written/verbal communication skills


Title: Sr. Software Quality Assurance Engineer
Location: Pittsburgh, PA

Overview:
As a Sr. Software Quality Assurance Engineer, you will be responsible for development and execution of software test plans, validating the functionality of software as defined in the Software Design and Requirements specifications. You will have a high level of interaction with software development engineers, reviewing requirements for testability. You will lead software validation activities including: risk assessment, usability engineering, design review, and bug tracking. Successful incumbents in this position will combine competencies from software engineering, quality assurance, and systems engineering.

Qualifications:
+ Bachelor’s degree or higher in computer science, engineering or related field
+ 10 or more years’ experience testing large-scale C++ projects
+ Familiarity with Unix/Linux operating system
+ Excellent analytical problem solving and organizational skills
+ Ability to communicate with systems users and present results of tests and experiments in text, tabular and graphic form.
+ Ability to write software quality test reports
+ Experience in developing and executing manual and automated test suites
+ Familiarity with software QA tools and techniques, including bug tracking systems, test design and execution
+ Experience working in a variety of programming languages and environments
+ Working knowledge of some or all of the following quality assurance methods: unit, integration, regression, user interface automated testing.
+ Working knowledge of FDA regulations for Medical Device Software Quality Assurance

Additional Qualifications:
+ Working knowledge of automated software testing and analysis tools
+ Knowledge of CMMI requirements
+ Understanding of 3D geometric concepts such as rotation matrices and coordinate transforms
+ Familiarity with ISO standards for software design, development and testing such as ISO/IEC 42010:2007, IEC 62304, ISO/IEC 14971:2012, and IEC 62366.
+ Programming experience with C/C++ and scripting languages


Title: Field Service Technician
Location: Plymouth, MN

Overview:
Blue Belt Technologies, Inc., a Pittsburgh-based medical device company, was formed in 2003 to commercialize novel hardware solutions for medical interventions. This position works under the supervision of the Service Manager. Consults with Manager on a daily basis to understand priorities, assignments and for technical expertise.

Responsibilities:
+ Provide service to Blue Belt product in the field and at Blue Belt facilities.
+ Coordinate service visits with Blue Belt and customer contacts.
+ Schedule travel arrangements and complete expense reports in a timely manner.
+ Provide technical and operational training as needed.
+ Complete service documentation in a timely manner.
+ Troubleshoot and resolve system issues.
+ Utilize phone skills to assist Clinical Representatives with troubleshooting to resolve system issues.
+ Create drawings, documents, and procedures to support depot and field service processes.
+ Communicate status and provide updates routinely.
+ Works within the confines of the established document control policies and procedures.
+ Provides feedback to Engineering regarding system performance issues, suggestions to improve field testing.
+ Becomes subject matter expert regarding system performance, error code interpretation, and resolution
+ Understand and be proficient with electronic and mechanical measurement devices (probes, oscilloscopes, multi-meters, soldering tools, micrometers, scales, etc.).
+ Utilize hand-tools to disassemble and assemble devices and the ability to solder.
+ Proven knowledge of troubleshooting experience of microprocessor based technology to component level.
+ Maintain the ability to work in cross functional teams with minimal supervision.
+ Works within the confines of the established document control policies and procedures to provide consistent work output.
+ Working knowledge of Microsoft Office applications, namely Word and Excel. Proficient with utilizing pc to diagnose device performance.
+ Ability to interact effectively at all levels of the organization
+ Willingness to work extended hours, evenings and weekends as needed.
+ Possess the ability to work in a fast paced environment with rapidly changing priorities while demonstrating initiative and tenacity.
+ Proven sound judgment, values driven, continuous innovation and improvement and adaptability skills.
+ Holds a valid MN driver’s license.
+ Local or National Travel – 60%
+ Field conditions represent the primary working environment.
+ Ability to lift up to 65 pounds on a daily basis
+ Extended hours may be required to complete projects within established time frames.
+ Travel to customer locations.

NOTE: The above statements are intended to describe the general nature and level of work being performed by employees assigned this job. They are not exhaustive lists of all duties, responsibilities, knowledge, skills, abilities and working conditions associated with the job. Additional functions may be required to meet company objectives.

Experience:
+ 2-Year Associate Degree – Biomedical Technology, Electronics Technology
+ 3 years or more experience servicing electrical and mechanical devices preferably in the hospital medical device support industry with an associate’s degree in a technology discipline preferred.
+ Possess analog and digital troubleshooting experience down to the component level.
+ Ability to solder and work with the components associated with surface mount and through hole PC cards.
+ Ability to read and interpret technical manuals and schematics required.
+ Technical writing and communication (Test Reports, Test Protocols, Procedures, etc.).
+ Strong mechanical aptitude.
+ Experience training clinical personnel


Title: QA Manager- MN
Location: Plymouth, MN

Overview:
Blue Belt Technologies, Inc., a Pittsburgh-based medical device company, was formed in 2003 to commercialize novel hardware solutions for medical interventions. The QA Manager’s responsibilities include managing quality system processes while ensuring compliance with customer, organizational and regulatory requirements. They also support manufacturing and other projects initiatives within a fast-paced dynamic environment.

Responsibilities:
+ Working knowledge of ISO 13485:2003, FDA’s QSR requirements, and MDD in EU.
+ CE Mark and labeling experience is a plus.
+ Experience in implementation and maintenance of QA processes and procedures in a low to medium volume electro-mechanical and/or Med Tech assembly environment.
+ Knowledge of supplier processes associated with metal fabrication, plastic, electronics assembly, and sterilization processes.
+ Experience in developing and implementing process validation and control systems.
+ Project Management & Quality Planning
+ Managing suppliers, NCM’s, Calibration, Preventive Maintenance, Environmental Controls, Inspection systems
+ Participate on safety team
+ Order processing and manufacturing operations (BOM’s, SWO’s, etc.)
+ Approving and originating Document Change Notices
+ Conducting Training
+ Working with:
Suppliers (Certification, Audits, SCAR’s, Inspection criteria, NCM’s, Risk Assessment Evaluations, Process Capability assessment, etc.)
+ Production environments building high-quality products
+ GMP and ISO 13485 quality system requirements
+ Auditing to FDA and ISO 13485 quality systems (Internal – External/Supplier)
+ Inspections: Receiving/Incoming, product final assembly, test and release
+ Document and Records Control systems
+ Process Validation (IQ, OQ, PQ)
+ Device Master Records, Device History Records, etc.
+ Creation of Metrics to drive Continuous Improvement activities
+ Must be proficient using Microsoft office including excel and word
+ Demonstrated experience with managing employees including hiring, developing, coaching, etc.
+ Strong supervisory, employee relations and employee development skills
+ Ability to interact effectively at all levels of the organization
+ Willingness to work extended hours, evenings and weekends as needed.
+ Office conditions represent the primary working environment.
+ Extended hours may be required to complete projects within established time frames.
+ Travel to customer locations.
NOTE: The above statements are intended to describe the general nature and level of work being performed by employees assigned this job. They are not exhaustive lists of all duties, responsibilities, knowledge, skills, abilities and working conditions associated with the job. Additional functions may be required to meet company objectives.

Experience:
+ BS degree in a Scientific Discipline (Engineering, Physics or Biology).
+ Minimum 5 years’ experience in a QA leadership or engineering role in a Medical Device Company.

For consideration please forward resume including position applying for and salary requirements to info@dareent.com or fax to 412.231.6101