R&D Engineer

Company: Medline
Location: Redmond
Posted on: September 18, 2023

Job Description:

JOB SUMMARY

Under general supervision, responsible for researching, developing, designing, prototyping, testing, verifying and validating, documenting, and releasing product solutions. Provide expertise on product design and optimize design specifications.

Responsible for researching, designing, prototyping, testing, validating, documenting, and releasing test systems for manufacturing reprocessed devices and the associate product solution.

Contribute to technology development activities as part of product development and manufacturing engineering projects.

MAJOR RESPONSIBILITIES

• Product solution and manufacturing test systems tasks include:
  • investigate user needs and product requirements/specifications,
  • coordinate or perform design efforts,
  • understand and contribute to regulatory strategy and applicable standards,
  • perform verification and validation activities,
  • perform design transfer activities to production environment,
  • determine performance impacts and process change of new materials and designs
  • conduct risk assessment activities and resolve residual risk
  • Develop user and functional requirements and design inputs for technological solutions and associated test systems.
  • Assist with the creation of new designs, generate/evaluate prototypes, and produce technical drawings/specifications for product solutions and associated test systems.
  • Responsible for designing, developing, coding, testing, debugging and maintenance of embedded software for product solutions and test fixtures.
    • Generate and review the necessary documents with project teams (software requirements specification, design, architecture, develop code, risk documents, unit testing, etc.)
    • Responsible for designing, developing, and generating printed circuit boards and assemblies, testing, debugging and maintenance of product solutions and test fixtures.
      • Generate and review the necessary documents with project teams (hardware requirements specification, design, drawings, risk documents, unit testing, etc.)
      • Execute verification and validation protocols, test plans, and procedures to qualify/validate product solution system and associated test system. Author reports for regulatory audits, submissions, and requests.
      • Perform test method development activities including test fixture design, equipment acquisition, and hardware/software validation.
      • Research and recommend new equipment/methods and perform necessary qualifications.
      • Support Product Development during device validation processing, testing, and regulatory submission.
      • Investigate root causes of failure for product solution and/or test system based on production needs or customer complaints. Work with teams to implement corrective actions.
      • Participate in design reviews for electronics and software/firmware and apply design principles, best practices, and current standards.
      • Review existing products and recommend improvements based on existing complaints, risk analyses, manufacturer feedback, cost saving opportunities, etc.
        Qualifications :
        
        COVID-19 Vaccination
        
        Please be aware that Medline requires all employees starting in this position to be fully vaccinated against COVID-19. This position will require the successful candidate to provide proof that they are fully vaccinated by their start date. Medline is an equal opportunity employer, and will provide reasonable accommodations to those individuals who are unable to be vaccinated for COVID-19 consistent with federal, state, and local law.
        
        MINIMUM JOB REQUIREMENTS
        
        Education
        • Bachelor's degree in Electrical Engineering, Computer Science, Computer Engineering, Software Engineering, or related field.Work Experience
          • At least 2 years of experience engineering hardware and software solutions
          • Experience with medical device requirements, design controls, risk assessments, and the 510k process
          • Experience with Design Control (ISO 13485, 21 CFR 820) procedures and Risk Management processes (ISO 14971)PREFERRED JOB REQUIREMENTS
            
            Work Experience
            • At least 4 years of experience.
            • Experience with encryption algorithms, CRC generation and cyber security
            • Experience designing and launching class II medical devices to market.
            • Experience leading multi-disciplinary teams.
            • Experience working in an Agile software development environment
            • Experience with embedded system design & validation
            • Experience with Medical device SW - Lifecycle processes: IEC 62304
            • Familiar with GUI interface development / UI external library development
            • Familiar with Source control programs
            • Experience with C/ C++/C#, Python, and Java
            • Experience with Medical Device electrical safety testing & protocol development: IEC 60601Required
              Preferred

              Job Industries

              • Warehouse & Production

Keywords: Medline, Bend , R&D Engineer, Engineering , Redmond, Oregon