Job Description

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 \xe2\x80\x93 finding ways to simplify, standardize and automate.
• Data managers. People who enjoy compiling, organizing and consolidating large volumes of data and reports.
• Data translators. Highly effective communicators who can transform data findings into recommendations to compose reports and executive level presentations.
• Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations.
• Self-directed imitators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.

What you will do:

• Responsible for test performances of cleaning validation at lab (cleaning validations with protein, hemoglobin, and other biochemical markers) and support present and future capabilities.
• Perform and support team for testing for cleaning validations, material characterization and related fields like reprocessing.
• 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.
• Apply GLP, cGMP, ANSI, AAMI, ISO, FDA, EPA, and USP guidelines cleaning, disinfection, cytotoxicity, bacterial endotoxin, and biocompatibility analysis of medical devices.
• Independently lead, prioritization and timely execution of complete project deliverables. Hold self-accountable to deliver on tasks & meet business deadlines.
• 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:

• Educational Qualification of M Pharm/ MSc/ MTech - in Pharma, Analytical Chemistry, Biochemistry, Biotechnology, Bioengineering.
• Experience: 7 -9 years. Min 6 years of experience specializing in analytical chemistry, medical devices or pharmaceutical or biological/ biochemistry testing, research, and development experience.
• Knowledge of different regulatory bodies (USFDA, EU, PMDA, MHRA etc) in production requirements of medical devices/pharma etc.
• Strong Instrument working knowledge with results analysis on equipment/ instruments used in chemical and analytical laboratories such as TOC analyzer, Spectrophotometer, HPLC, GC, GCMS, LCMS, AAS, ICP-OES/ ICPMS, DSC, TGA, FTIR 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.
• Ability to use different standards like ISO, AAMI, USP, ANSI, EPA, EU for testing and related guidelines toward the design, verification, manufacturing, in medical device/ pharma.
• Demonstrated ability to prioritize tasks in a deadline-driven environment and to communicate complex plans and technical information to team members and multi-national teams.
• Demonstrated knowledge about a variety of microbiological and chemistry-based concepts, practices, and procedures and competency in advanced testing technologies.

About Stryker

Stryker is one of the world\xe2\x80\x99s 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