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.
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.
Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
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 Document review, Design Output Document review, V&V protocols and reports review, Review and approval of CER.
Participate in Risk Management per ISO14971 to ensure the safety and effectiveness of product.
Responsible to ensure provisions of Design Control processes are followed and associated reviews are conducted.
Participate in design reviews during various phases of NPD.
AQE should drive coordination with different departments (such a R&D, BML, Regulatory, Clinical) to ensure the resulting part/product/process is safe, compliant, and effective.
Work with team to develop robust verification, validation & release strategies to ensure product compliance, safety, reliability & effectiveness.
Expert-level knowledge of current industry standards for New Product Development and risk management practices.
Solutions-based approach to quality engineering, wants to provide "added value" ("quality police" attitudes won't survive in our culture).
What you will need:
Education: B.Tech/M.Tech in Mechanical Engineering / Computer Science / Biomedical
10+ years' experience in new product development focused on quality engineering related activities.
Good interpersonal and communication skills
Good understanding of Quality Management Systems. (ISO 13485, 21 CRF 820)
Experience on NPD process and various phases of new product development.
Knowledge of ISO 14971, IEC 62366, 60601-1 family of standards.
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.
Establish world class risk methodologies for complex systems based upon existing corporate/divisional approaches.
Educate the organization in exceptional engineering processes & practices; including good documentation, formal design reviews and the other practices mentioned above.
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