Job Description

About Stryker

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 one of the World's Best Workplaces and a Best Workplace for Diversity by Fortune Magazine. Learn more about our award-winning organization by visiting stryker.com

Who we want
Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
Goal-oriented developers. Keeping the customer and system requirements squarely in focus, people who deliver safe and robust solutions.
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.

User-focused creators. People who imagine with the user in mind, developing technology that helps change patients lives.

Site Overview:

Strykers Sustainability Solutions (SSS) is the leading provider of reprocessing and re-manufacturing services for single-use medical devices.

Reprocessing of single-use medical devices (SUDs) is the practice of inspecting, cleaning, function testing, sterilizing and packaging so that they can be clinically and safely used again. We are looking for a Post-Market Quality Engineer to support these efforts!

What you will do:

As a Post-Market Quality Engineer, you will develop and implement methods and procedures for process control, process improvement, testing and inspection to ensure that the products are free of flaws and function as designed. Design and install sophisticated testing equipment and perform product testing and analysis to maintain quality levels and minimize defects and failure rates. Analyze reports and defective products to determine trends and recommend corrective actions. Collaborate with supplier representatives on quality problems, ensure that effective corrective actions are implemented and contribute to supplier quality improvement programs.

Responsibilities:

* You will design and/or implement standard methods and procedures for inspecting, testing, and evaluating the precision and reliability of post-market products.
* You will support post-market investigations through quality systems such as PMHRA, NC/CAPA, and PFA
* You will analyze, report and recommend corrective actions.
* You will develop and execute standard processes and product protocols.
* You will bring fundamental knowledge of applicable regulations and standards (e.g. QSR, ISO 13485)
* You will provide sound statistical rationale for test sample size determinations.
* You will use sound statistical rationale to analyze and interpret engineering test data collected during post-market device testing.
* You will analyze, design, and/or improve standard manufacturing procedures and engineering systems for post-market medical devices.
* You will perform standard post-market engineering risk analyses to manage technical difficulties.
* You will participate and aid in the post-market product development process by identifying standard test methods.
* You will interface with multiple departments and teams such as R&D, Regulatory Affairs, Operations, and Marketing to ensure specific post-market quality metrics are met.
* You will improve and/or support existing processes.
* You will support team initiatives
* You may interact with customers to solve product quality issues and /or answer general product questions.
* You may be asked to train others in quality assurance / GMP related topics.

What you need:

Basic Qualifications:

* Bachelors Degree in Engineering

Preferred Qualifications:

* Experience in Mechanical, Electrical, Chemical, Material Science, or Biomedical Engineering
* Strong verbal and written communication skills; ability to present issues, plans and objectives
* Excellent organizational, problem solving, and analytical skills
* Ability to manage priorities and workflow
* Versatility, flexibility, and a willingness to work within constantly changing priorities
* Ability to handle multiple projects and meet deadlines
* Good judgment with the ability to make timely and sound decisions.
* Working knowledge of data collection, data analysis, and evaluation, and scientific method
* Ability to observe and note minute inconsistencies
* Ability to generate, follow, and explain detailed instructions and inspection procedures
* Ability to complete detailed documentation accurately
* Ability to analyze and resolve routine issues using independent judgment

Know someone at Stryker?

Be sure to have them submit you as a referral prior to applying for this position. Learn more about our employee referral program.