Senior Engineer, Digital Quality

Why engineering at Stryker?

At Stryker we are dedicated to improving lives, with a passion for researching and developing new medical device products. As an engineer at Stryker, you will be proud of the work that you will be doing, using cutting-edge technologies to make healthcare better. Here, you will work in a supportive culture with other incredibly talented and intelligent people, creating industry-leading medical technology products. You will also have growth opportunities as we have a culture that supports your personal and professional development.

Need another reason to apply? Check out these 8 reasons to join Stryker's engineering team: https://www.strykercareersblog.com/post/8-reasons-to-join-strykers-engineering-team

Who we want:

• Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes - finding ways to simplify, standardize and automate.
• Self-directed imitators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
• Goal-oriented developers. Keeping the customer and requirements squarely in focus, people who deliver safe and robust solutions.
• Delivers results. A driven player 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:

• Primarily responsible for: Risk Management, Design Inputs review, Design History File Documents review, Design Output Document review, Test log test plans, Software verification and Validation.
• Participate in Risk Management per ISO14971 to ensure the safety and effectiveness of product.
• Responsible to ensure provisions of software life cycle processes are followed and associated reviews are conducted.
• Conduct design reviews during various phases of NPD.

• Work with team to develop robust verification, validation & release strategies to ensure product compliance, safety, reliability & effectiveness.
• Work with team to develop robust software architecture as per quality and regulatory requirements.
• Expert-level knowledge of current industry standards for software engineering and risk management practices ideally from the domain of safety critical applications
• Demonstrated ability to apply software and system quality management practices in efficient and effective ways while being compliant.
• Solutions-based approach to quality engineering, wants to provide "added value" ("quality police" attitudes won't survive in our culture).
• Good interpersonal and communication skills.
• Ability to review Defects.
• Ensure that software, mechanical, electronic, and material/implant engineering follow the same approaches, wherever possible, to ensure seamless cooperation between these diverse disciplines and their associated system responsibilities.
• Provide expertise in establishing good specifications and protocols like requirements, architecture, detailed design, verification & validation planning, etc.
• Establish world class risk methodologies for complex systems based upon existing corporate/divisional approaches.
• Conduct and moderate all kind of Design Reviews (e.g. SRS Reviews, source code reviews, etc.).
• Establish overall system test design in cooperation with test engineering.
• Educate the organization in exceptional engineering processes & practices; including good documentation, formal design reviews and the other practices mentioned above.

What you need:

4-7 years of experience in New Product Development focused on Digital Quality Engineering related activities. Strong preference given to medical device industry experience.

• Bachelor's degree in Software Engineering/ Computer Science or related discipline & 4-7 years of work experience.

Preferred Qualifications (Strongly desired):
Technical Skills:

• Experience on Medical Device Software Development Life Cycle Process (SDLC) IEC 62304
• DQA shall drive coordination with different departments (such a R&D, Testing, Regulatory, Post Market Quality) to ensure the resulting part/product/process is safe, compliant and effective
• Experience on NPD process and various phases of new product development.
• Knowledge of ISO 14971, IEC 62304, 60601-1 family of standards.
• Understanding of Quality Management Systems. (ISO 13485, 21 CRF 820, ISO 9001)
• Familiarity with basic programming language, embedded software & tools.

Software Process Skills:
• Software Development Life Cycle processes
• Regulatory and compliance standards applied to the SDLC (Software Development Life Cycle)

About Stryker

Stryker is one of the world's leading medical technology companies and, together with our customers, is driven to make healthcare better.

The company offers innovative products and services in Medical and Surgical, Neurotechnology, Orthopedics, and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 100 million patients annually.

More information is available at stryker.com