• Senior Engineer Advanced Quality Jobs in United States Of America - 25365891

  • United States Of America, Usa
  • Save Job
  • 2 - 5 Years
  • Posted : above 1 month

Job Description:

We are a great place to work Fortune, in association with Great Place to Work, named us among the Worlds Best Workplaces We ranked #8 out of the 25 companies on the list This list highlights companies that have gone above and beyond to create a great workplace for employees all over the world Fortune also named us one of the 100 Best Companies to Work For in the United States This is the ninth consecutive year we have been on the list, and we ranked #11 out of 100!

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 (eg 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

Bachelors degree in an engineering or science field
2 years experience in Mechanical, Electrical, Chemical, Material Science, and/or Biomedical Engineering - Electrical Engineering preferred
Six Sigma Green Belt or ASQ CQE preferred
R&D and/or NPD experience preferred

Why Stryker Its the people Thats the answer youll hear most often when you ask our employees why they love working here Come join our team in Arizona at Stryker!

Work From Home Not available

Travel Percentage Up to 25 PERCENT

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 contractors legal duty to furnish information

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Manufacturing/Industrial, Healthcare
Functional Area : Production/Manufacturing/Maintenance/Packaging
Role : Production/Manufacturi ng/Maintenance
Salary : As per Industry Standards
Deadline : 09th Jun 2020

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