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.

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.