Engineer, Post-Market Quality

Stryker Corporation Phoenix , AZ 85002

Posted 3 months ago

Job Description:

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:

Stryker's 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 andrecommend 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:

  • Bachelor's Degree in Engineering

Preferred Qualifications:

  • Experience in Mechanical, Electrical, Chemical, Material Science, or Biomedical Engineering

Work From Home: No

Travel Percentage: Up to 25%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.


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