Senior Engineer- Software AQE

Work Flexibility: Hybrid

Who we want Sets direction . An innovator who defines ways to create value and deliver on Stryker s mission and strategic imperatives. Builds organizational capability . A strategic executive who continuously breaks down barriers, identifying new and more effective ways to accomplish tasks and goals. Inspires others . A genuine, relationship-focused leader who connects, collaborates and fosters an inclusive environment of enthusiasm, trust and pride. He/she makes others want to follow, building momentum for action and positively influencing outcomes. Champions talent development . A manager who focuses on maximizing the ability, potential and contributions of themselves and others. Fosters an environment where people can excel through developing, coaching and rewarding performance. Delivers results . A driven player/coach who sets high goals for personal achievement and organizational success. He/she measures success against the best internal and external benchmarks. What you will do Will work within the new product development team, with responsibilities including, but not limited to the following:

• Developing software according to SDLC with a holistic approach on planning, defining requirements, testing, and deployment.
• Co-develops application-based software solutions in an Integrated Development Environment by conducting research to understand user needs, usability, data usage, systems flow, work processes, problem areas and bug reporting, and driving good code practices.
• Provide engineering input to impact the design, coding, verification, and validation of software in various coding languages including SOUP software.
• Performs software analysis, requirements analysis, software review, identification of code metrics, system risk analysis, and software reliability analysis
• Involved in API (application programming interface) based software while ensuring HSIT (Hardware-Software Integration)
• Lead project team through Software Defect Management in all phases of development, System Testing & Manual Testing
• 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 be involved in continuous improvement projects for the organization
• Involvement in training others
• Communicates effectively with team and management to drive project efficiency and status of progress with a focus on solutions.

• Knows and applies fundamental and some advanced concepts, practices and procedures of practical field of specialization

What you need:

• Bachelors or Master s degree in Software Engineering, Computer Science, Computer Engineering, Electronics 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.
• 5-6 years experience in an equivalent position within an R&D environment is preferred
• A minimum of three years experience in software quality is a distinct advantage
• 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

Travel Percentage: None