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.
Reports To: Senior Manager, Customer Quality Engineering
What you will do
Responsible for continuous product and process quality improvements. Conducts investigations into NCs and CAPAs stemming from the products in the field. Leads root cause activities and Identifies potential failure modes and risks, and resolves customer issues appropriately. Knows and applies the fundamental concepts, practices, and procedures of the general Quality and Regulatory environment, Post-market in particular.
Gather and analyze Post Market trending data (e.g. Q, service reports, complaints, MDR/MDV) to identify opportunities for quality improvements
Ownership of activities that lead to improvement in Physio-Control Quality metric (Q)
Lead and/or support NC and CAPA process and NC and CAPA investigations
Communicate with Customers, members of Field Service and Sales organizations to gather information necessary to carry out investigations.
Provide outstanding customer support with investigation updates to internal and external customers
Work with multifunctional teams (Ex: R&D, Operations, Manufacturing Engineering, Field Service, and Sales) to drive resolution for NCs and CAPAs
May support Engineering Change Orders (ECO) and Process Change Orders (PCO)
Support and communicate with complaint handling function to ensure trending information is accurate and up to date
Champion determination of "true" root cause by utilizing appropriate problem solving tools
Document accurately and thoroughly NC and CAPA investigations
Conduct/Update risk analyses and track all findings, along with development of Risk Management portfolio, as required.
Calculate Failure/Harm occurrence rankings based on field data as required
Lead risk documentation updates based on field data.
Provide post-market input and feedback on safety, durability, craftsmanship, and reliability design input specifications for Quality report, design reviews, risk analyses, and customer research.
Develop statistical rationale for testing, when required, to address post market issues.
Develop the rationale for validation sample size, duration, and number of locations.
Support quality assurance engineering responsibilities after launch with post market monitoring and voice of customer.
Contribute to maintaining the risk management portfolio for product life.
Provide Post Market trending data (e.g. Q, service reports, complaints, MDR/MDV) to the organization
Present Post Market trending data to the business
Monitor compliance to Quality Procedures and FDA Quality System Regulations (QSR's) and update as necessary.
Support field action related activities i.e. investigations, HHEs, presentations etc.
Support internal and external audits (FDA, ISO, MDSAP etc.)
What you will need
Bachelor's Degree required, with area of study in engineering or related field required.
Working knowledge of failure investigation techniques and related tools: 8D, 6 Sigma, Root Cause Analysis, preferred.
0 - 2 years of related experience required.
Prior related experience in a regulated environment highly desired.
Prior related experience investigating, troubleshooting and root causing highly preferred Competent with Microsoft Office (Outlook, Excel, Word, etc.).
Must possess excellent oral and written communication skills.
Ability to solve problems in a high stress situation and to make effective decisions.
Ability to work in a multi-functional team environment.
Possess attention to detail.
Eagerness to assist internal and external customers.
Manage projects in a timely manner.
Ability to conduct and document technical investigation.
The following experiences/skill sets are highly desirable:
ISO 13485 and ISO 14971
Industrial statistical techniques
Development and implementation of design and process controls
May be required to move equipment up to 50 pounds, reach, push, or pull in order to accomplish job accountabilities.
Coordination of eye, hand, and/or foot movement with an ability to grasp by hand and meet cognitive demands to include visual and auditory discrimination/memory, reading ability, and memory retention ability.
Requires use of safety glasses in designated areas.
Closed-toe shoes must be worn on the production floor; safety shoes are recommended.
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