Senior Software Quality Engineer

Staff Software Quality Engineer

Work Flexibility: Hybrid

What will you do:

• Developing software according to SDLC with primary points of focus on  planning, defining requirements, testing, and deployment.

• Co-develops software solutions by conducting research to understand user needs, data usage, systems flow, work processes, problem areas and bug reporting, and driving good code practices.

• Provide engineering input to impact the design, coding and debugging of software in various coding languages including SOUP software.

• Performs software analysis, code analysis, requirements analysis, software review, identification of code metrics, system risk analysis, and software reliability analysis

• Performs Software build, Maintenance, and change control. Maintains software configuration management in Perforce.

• Lead project team through Software Defect Management in all phases of development. 

• Collaboration with other engineering disciplines, such as electrical, mechanical and industrial design, to ensure that embedded software will accomplish design goals for a particular product or system.

• Help guide New Product Development teams through our quality system to ensure software is developed in compliance to internal procedures as well as the requirements of the FDA, ISO, and other regulatory bodies, which may include: FDA, ISO 13485, ISO14971, FDA 21 CFR Part 11, FDA 21 CFR 820.30 and Sub-clause 4.4 of ISO 9001, ANSI AAMI IEC 62304:2006 (formerly AAMI SW68), AAMI TIR32, AAMI TIR36, AAMI SW87, AAMI TIR45, IEC 80001-1, BS EN 60601-1-2: 2007, CEI IEC 60812, IEC TR 80002-1, DS DS/EN 61508-6, ISO 60601-3rd Edition and FDA General Principles of Software Validation GPSV requirements

• Review and evaluate project documentation for compliance as well as sound technical competence to ensure we are delivering robust products.

• Perform software risk analysis and develop risk control measures and test strategies to ensure safe and reliable products are launched to Stryker’s high quality standards.

• May have involvement in continuous improvement projects for the organization

• Experience with Product Security at development stage

What you will need:

Basic Qualifications:

• Bachelor's or Master’s degree in Software Engineering, Computer Science, Computer Engineering, Electrical Engineering, or related field or equivalent discipline is required.

• Regulated industry experience such as Medical, Aerospace, Defense, Communication, and/or automotive embedded software control experience is a plus.

• 7+ years experience in an equivalent position in software test or quality within an R&D environment is preferred

• ISTQB or ASQ CSQE or equivalent experience and certification is desirable

• Excellent communication skills and attention to detail

• Has a strong understanding of engineering and quality practices & methods

• High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel, PowerPoint and One Note.

Preferred Qualification:

• Self-starter with demonstrated efficient work methods, analytical & problem solving skills and ability to handle multiple tasks in a fast paced environment.

• Highly developed problem solving and strong analytical skills

• Builds strong relationships by fostering open communications, respect and trust. Strong team player and acts with a customer service/stakeholder focused approach

• Is diplomatic, tactful and leverages excellent interpersonal skills to help achieve outcomes.

• Manages change well and adopts a continuous improvement orientation to the role

• Ability to be the voice of Quality when dealing cross functionally. Will take the lead in discussions / meetings to ensure the correct outcome.

• Excellent English (both oral and written)

Travel Percentage: 10%

Experience Level

Senior Level