Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes.
We are proud to be named the #5 World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine. Learn more about our award-winning organization by visiting stryker.com
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.
This position is primarily responsible for the remediation of embedded firmware and hardware for medical imaging devices and robotic assisted interventions. This is a critical position within the R&D team providing embedded software documentation support in the design, development, and continuous.
The Remediation Engineer will help ensure that software/firmware project and process control documentation are compliant with established procedures and will be responsible for performing various software verification and validation activities whose main purpose is to facilitate continuous improvement for both existing products and processes, and to support new product/process development activities.
These activities include design verification and validation, design control & documentation, and hands-on software/firmware testing by performing the following duties.
Who we need
Qualifications & experience:
Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
Dedicated achievers. Relentless about quality, people who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
Collaborative partners - People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.
Self-directed imitators - People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
Effective communicators. People who regularly share relevant status updates and effectively articulate issues and recommendations to stakeholders and senior management.
What you will do
Essential duties & responsibilities:
Lead all design, test, safety. and compliance documentation in embedded firmware related projects
Enhance current design and verification processes and procedures to ensure a streamlined process and a timely agency approval
Conduct software/firmware compatibility tests with programs, hardware, operating systems, or network environments.
Develop accurate reports and documenting test results for various stakeholders and for inclusion in the Design History File.
Review product requirements for traceability, risk remediation and testability.
Review verification and validation deliverables for compliance with regulatory requirements
Review software/firmware documentation to ensure technical accuracy, compliance, or completeness, or to mitigate risks.
Provides feedback and recommendations on specific features and designs to developers on software/firmware usability and functionality and participate in formal and informal reviews to determine quality.
Provide alignment with development team and may assist SW Test technicians in their daily activities
Workload permitting, support image quality testing, and other functions in need of test support for Sustaining Engineering and Development programs
What you need
Education & special trainings:
Bachelor's degree (B.A. or B.S.) in Engineering, Computer Science, Physics, Math or a related field from a four-year college or university; or equivalent
2+ years of firmware / system design, test, or quality experience.
Working knowledge of appropriate global medical device regulations, requirements, and standards, such as 21 CFR Part 820, ISO13485, ISO14971, European Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282), Japanese MHLW Ordinance 169, and ISO 9001 is highly preferred.
Experience within the medical device / FDA regulated industries
Knowledge of Product design and development, FMEA, PFMEA, Risk management, CAPA Process, Verification and Validation experience, Measurement system analysis experience.
Ability to effectively manage multiple conflicting priorities in fast-paced environment.
Ability to learn and absorb product knowledge quickly and efficiently
Ability to communicate effectively via phone and email.
Stryker is one of the world's leading medical technology companies and, together with our customers, we are driven to make healthcare better. The Company offers a diverse array of innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. Stryker is active in over 100 countries around the world.
Together with our customers, we are driven to make healthcare better.
At Stryker, quality is first in everything we do. We are driven to make healthcare better for our customers by
providing innovative products and services that meet regulatory requirements through our effective quality system.
The Company was founded in 1941 by Dr. Homer Stryker and incorporated in 1946 as the Orthopedic Frame Company. In 1964, the Company’s name was changed to Stryker Corporation.
• $13.6 billion in annual sales in 2018; annual revenue has grown for 39 straight years
• 17.1% CAGR (compound annual growth rate) in sales over 39 years
• ~36,000 employees globally in 2018
• 43 manufacturing and research & development locat...ions worldwide
• Included in the Standard & Poor’s 500 Index
• Ranked # 233 on Fortune Magazine’s “FORTUNE 500” list for 2019
• Ranked # 3 on Fortune Magazine’s “World’s Most Admired Companies” list for the “Medical Equipment” industry for 2019
• Ranked # 11 on Fortune Magazine’s “100 Best Companies to Work For” list (U.S.) for 2019
• Spent $862 million on R&D in 2018
• 7,784 patents owned globally in 2018
• Initial public offering of stock was in 1979
• Listed on the New York Stock Exchange under ticker SYK