Sr. Test Engineer

Medtronic•Boxborough, MA

1d•Hybrid

About The Position

Sr. Test Engineer for Medtronic, Inc., located in Boxborough, MA. Responsible for providing software R&D and software test engineering support to ensure the successful development of Medtronic Neurovascular devices, design transfers, scale-up and ongoing operational support. Evaluate requirements for quality and completeness to ensure they meet the user’s needs. Test advanced image reconstruction and processing algorithms. Generate test protocols based on product requirements and project needs. Ensure software applications and systems software meet technical and functional requirements. Perform workflow analysis, document test results and recommend quality improvements. Responsible for medical device product verification, developing test protocols, planning, and tracking project team progress. Coordinate New Product Design (NPD) including reviewing requirements, design, usability, risk assessment and defects. Leverage various Software Development Life Cycle (SDLC) methodologies for software and hardware verification, troubleshooting, and identification and cataloging of software defects. Navigate the complexities of various medical device regulations and requirements to include FDA 21 CFR Part 11, ISO 14971, ISO 13485 and IEC 62304. Review test automation frameworks, tools, techniques, and methodologies, and utilizing automation tools including Azure DevOps, LabVIEW, and Test-Complete. Utilize Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP). Work with high voltage, small form factor X-Ray generators and sources including SEDECAL generators, cone-beam X-Ray, X-Ray detector panels for medical imaging, including Varex flat detector panels. Ensure compliance with Industry standard medical imaging tools for 2D and 3D image evaluation and analysis with ImageJ software application, including Catphan Phantom, Modulation Transfer Function (MTF) Phantom Disk Stack, ACR Computed Tomography (CT) Phantom, Corgi Cone-Beam Computed Tomography (CBCT) Phantom, Fluoroscopic Resolution Test Tool, Spatial resolution tool and Contrast-Resolution Tool, and 45-cm acrylic radiopaque rulers. Leverage X-Ray dose measurement and evaluation tools including RTI-Piranha, RTI-barracuda, RTI-Ocean software, Dose Area Product (DAP) meter and pencil probe ion chambers and 16cm Computed Tomography Dose Indicator (CTDI) Dose Phantom and 32cm CTDI Dose Phantom. The position allows a hybrid work model and requires the employee to be onsite at the Boxborough, MA location 4 days per week. Relocation assistance not available. #LI-DNI. NOTICE: Pursuant to 20 C.F.R. § 656.10, you are hereby notified that an Application for Permanent Employment Certification will be filed for the job opportunity below. Any individual may provide documentary evidence bearing on this application, with information on available workers and information on wages and working conditions, to the Certifying Officer at the U.S. Department of Labor as follows: Certifying Officer U.S. Department of Labor Employment and Training Administration Office of Foreign Labor Certification 200 Constitution Avenue NW, Room N-5311 Washington, DC 20210

Requirements

Master’s degree in Electrical, Mechanical, or Biomedical Engineering or Computer Science or related engineering or technical field
two (2) years of experience as an R&D engineer, software engineer, or test engineer
two (2) years of experience with medical device product verification
test engineering for new product design
SDLC methodologies for software and hardware verification, troubleshooting, and identification and cataloging of software defects
FDA 21 CFR Part 11, ISO 14971, ISO 13485, and IEC 62304
reviewing test automation frameworks, tools, techniques, and methodologies, utilizing Azure DevOps, LabVIEW, and Test-Complete
GMP and GDP
high voltage, small form factor X-Ray generators and sources including SEDECAL generators, cone-beam X-Ray, X-Ray detector panels for medical imaging, including Varex flat detector panels
ImageJ software application
Catphan Phantom, MTF Phantom Disk Stack, ACR CT Phantom, Corgi CBCT Phantom, Fluoroscopic Resolution Test Tool, Spatial resolution tool and Contrast-Resolution Tool, and 45-cm acrylic radiopaque rulers
RTI-Piranha, RTI-barracuda, RTI-Ocean software, DAP meter and pencil probe ion chambers, 16cm CTDI Dose Phantom, and 32cm CTDI Dose Phantom

Responsibilities

providing software R&D and software test engineering support
Evaluate requirements for quality and completeness
Test advanced image reconstruction and processing algorithms
Generate test protocols based on product requirements and project needs
Ensure software applications and systems software meet technical and functional requirements
Perform workflow analysis, document test results and recommend quality improvements
medical device product verification, developing test protocols, planning, and tracking project team progress
Coordinate New Product Design (NPD) including reviewing requirements, design, usability, risk assessment and defects
Leverage various Software Development Life Cycle (SDLC) methodologies for software and hardware verification, troubleshooting, and identification and cataloging of software defects
Navigate the complexities of various medical device regulations and requirements to include FDA 21 CFR Part 11, ISO 14971, ISO 13485 and IEC 62304
Review test automation frameworks, tools, techniques, and methodologies, and utilizing automation tools including Azure DevOps, LabVIEW, and Test-Complete
Utilize Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP)
Work with high voltage, small form factor X-Ray generators and sources including SEDECAL generators, cone-beam X-Ray, X-Ray detector panels for medical imaging, including Varex flat detector panels
Ensure compliance with Industry standard medical imaging tools for 2D and 3D image evaluation and analysis with ImageJ software application, including Catphan Phantom, Modulation Transfer Function (MTF) Phantom Disk Stack, ACR Computed Tomography (CT) Phantom, Corgi Cone-Beam Computed Tomography (CBCT) Phantom, Fluoroscopic Resolution Test Tool, Spatial resolution tool and Contrast-Resolution Tool, and 45-cm acrylic radiopaque rulers
Leverage X-Ray dose measurement and evaluation tools including RTI-Piranha, RTI-barracuda, RTI-Ocean software, Dose Area Product (DAP) meter and pencil probe ion chambers and 16cm Computed Tomography Dose Indicator (CTDI) Dose Phantom and 32cm CTDI Dose Phantom

Benefits

Health, Dental and vision insurance
Health Savings Account
Healthcare Flexible Spending Account
Life insurance
Long-term disability leave
Dependent daycare spending account
Tuition assistance/reimbursement
Simple Steps (global well-being program)
Incentive plans
401(k) plan plus employer contribution and match
Short-term disability
Paid time off
Paid holidays
Employee Stock Purchase Plan
Employee Assistance Program
Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)