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.
Responsible for handling of cleaning validation capability at lab (cleaning validations with protein, hemoglobin, and other biochemical markers) and support in future material characterization capability.
Perform and support team for testing for cleaning validations, material characterization and related fields.
Perform qualification and validation of Bio-analytical methods and equipment(s). Manage consumables and equipment purchase required for testing and capability.
Time plan and strategy construction and work with different stakeholders for test and capability building.
Leading efforts for Chemical characterization, composition of medical devices and understanding the biocompatibility and mechanical properties.
Apply GLP, cGMP, ANSI, AAMI, ISO, FDA, EPA, and USP guidelines cleaning, disinfection, cytotoxicity, bacterial endotoxin, and biocompatibility analysis of medical devices.
Support team members to create or improve procedures, policies, processes, systems, and technology requirements.
Independently lead and timely execution of complete project deliverables. Hold self-accountable to deliver on tasks & meet business deadlines.
Mentor, influence and support team on design verification and validation test requirements that ensure appropriate objective evidence is available to support acceptance criteria. Work with team, technicians/ support staff and team on projects and capability.
Implement data analysis and statistical techniques to drive appropriate risk management activities and prioritization of issues.
Audits/ NC CAPA/ Deviations/ change control/ Procedures improvements/ risk evaluations and data/ record/ report reviews. Assess new and or required test technologies and capabilities for the organization.
Deliver high quality results with passion, energy, and drive to meet business priorities. Mentor, develop and influence across the business, intentionally building divisional relationships.
What you need:
M.Sc./ B.Tech/ M.Tech - in Analytical Chemistry, Biochemistry, Biotechnology, Bioengineering, Pharma, Microbiology with work experience: 10 -12 years
Min 7 years of experience specializing in analytical chemistry, medical devices or pharmaceutical microbiological or biological/ biochemistry testing, research, and development experience.
Strong Instrument working knowledge with results analysis on equipment/ instruments used in chemical and analytical laboratories such as TOC (Total Organic Carbon) analyzer, Spectrophotometer, HPLA, GC, GCMS, LCMS, AAS, ICP-OES/ ICPMS, DSC, TGA, FTIR, Steam sterilizer, Washer disinfector etc.
Possess an in-depth knowledge of the industry and competitive landscape, ensure effective implementation, and compliance to all applicable regulations and standards, including 21CFR820, ISO 13485, ISO 17025, ISO 14971 throughout the design and development process various test requirements.
Expert with extensive experience applying industry standards for device development and Verification/ validation testing and material characterization.
Good to have:
Worked with different regulatory bodies (USFDA, EU, PMDA, MHRA etc) in production requirements of medical devices/pharma etc.
Ability to use different standards like ISO, AAMI, USP, ANSI, EPA, EU for testing and related guidelines toward the design, manufacturing, development, and launch of initiatives in medical/ pharma.
Ability to effectively work cross-functionally with Product Development, Operations and Marketing.
Experience in medical device, pharmaceutical Quality management system and risk analysis tools and techniques.
Must be results oriented, a quick learner, team player and able to respond to the urgent needs of the team ensuring all deadlines are met.
Demonstrated ability to technically mentor associate engineers and scientists in work field.
Demonstrated ability to prioritize tasks in a deadline-driven environment and to communicate complex plans and technical information to team members
Demonstrated ability to effectively work with others in various coordinate disciplines and on multi-national teams.
Demonstrated organizational and written/verbal communication skills.
Demonstrated ability to self-motivate, effectively work with others in various coordinate disciplines and on multi-national teams.
Demonstrated knowledge about a variety of microbiological and chemistry-based concepts, practices, and procedures and competency in advanced testing technologies.
Internal Number: R455064
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