Job Snapshot
-
Employee Type:
Full-Time -
Location:
Tempe, AZ -
Job Type:
-
Experience:
Not Specified -
Date Posted:
2/9/2019 -
Job ID:
R405485
Job Description
Stryker is a global leader in medical technology with a history of success and exceptional growth. We offer results-driven people a place where they can make a difference. It is our privilege to create medical technology that exceeds our customers’ expectations and improves peoples’ lives around the world.
As a Senior Engineer, Advanced Quality for Stryker you will be a key member of the new product development team ensuring the implementation of cutting edge technology for medical devices is safe, effective, and compliant with industry practices. Working closely with R&D, Marketing, Advanced Operations, and Regulatory Affairs team members, you will be in a fast paced environment with opportunities to win for yourself, the company, and patients around the world. This position is a hybrid between a traditional R&D Engineer and a traditional Quality Engineer.
What You Will Do
- Represent Quality Assurance on the New Product Development (NPD) cross-functional team (CFT). Interface among multiple departments and teams such as R&D, Regulatory Affairs, Advanced Operations, and Marketing to ensure specific product development metrics are met.
- Create and implement the Risk Management File for an NPD team.
- Lead Risk Management activities for an NPD team, including identifying hazards and harms that may be associated with the medical device.
- Lead Design Reviews for NPD teams to ensure design and process robustness and compliance to Corporate and Divisional design control procedures.
- Lead the exercise of understanding the functional inputs and outputs of the medical device.
- Plan, design, and implement difficult methods and procedures for inspecting, testing, and evaluating the precision and reliability of products and/or production and/or test equipment.
- Analyze reports and recommend corrective action.
- Plan and develop difficult process and product protocols and monitors progress.
- Utilize a broad knowledge of applicable regulations and standards (e.g. QSR, ISO 13485) and how to apply the principles, practices, and procedures
- Provide and review advanced statistical techniques for test sample size determinations.
- Use and review advanced statistical rationale to plan, analyze, and interpret engineering test data collected during new medical device testing.
- Plan, lead, monitor, and control progress of difficult projects to ensure sound application of engineering principles are used, and design intent is being achieved.
- Plan, select, analyze, design, and improve difficult manufacturing procedures and engineering systems for medical devices.
- Plan and verify that new difficult engineering devices are technically sound and in compliance with FDA and other regulatory bodies.
- Plans, performs, and reviews difficult engineering risk analyses to manage technical difficulties encountered with new medical devices.
- Provide leadership in the product development process by identifying effective test methods.
- Provide leadership and influence among multiple departments and teams such as R&D, Regulatory Affairs, Operations, and Marketing to ensure specific product development metrics are met.
- Lead and facilitate periodic design reviews during the product development process.
Supervisory Responsibilities
- May train others in quality assurance / GMP related topics.
- May direct and/or evaluate the activities of one or more Advanced Quality Engineering technicians, Associate Advanced Quality Engineers, or Advanced Quality Engineers.
What You Need
- 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
Education and/or Experience
- Bachelor's degree in an engineering or science field.
- Minimum of 2-3 years’ experience in Mechanical, Electrical, Chemical, Material Science, and/or Biomedical Engineering.
- Six Sigma Green Belt or ASQ CQE preferred..
- R&D and/or NPD experience preferred.