Senior Design Quality Engineer

Profile

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 the #5 World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine. Learn more about our award-winning organization by visiting stryker.com

Why engineering at Stryker?

At Stryker we are dedicated to improving lives, with a passion for researching and developing new medical device products. As an engineer at Stryker, you will be proud of the work that you will be doing, using cutting-edge technologies to make healthcare better. Here, you will work in a supportive culture with other incredibly talented and intelligent people, creating industry-leading medical technology products. You will also have growth opportunities as we have a culture that supports your personal and professional development.

Need another reason to apply? Check out these 8 reasons to join Stryker's engineering team: https://www.strykercareersblog.com/post/8-reasons-to-join-strykers-engineering-team (https://www.strykercareersblog.com/post/8-reasons-to-join-strykers-engineering-team )

Who we want

Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.

Dedicated achievers. Relentless about quality, people who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.

Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.

What you will do

As a Senior Design Quality Engineer, you will be responsible for leading quality engineering efforts for post market and new product development. You will have the responsibility to drive reliability engineering, human factors engineering, risk management, and design validation & verification, while ensuring compliance to FDA Quality System Regulations and ISO 13485.

You will guide new product development teams through internal quality system requirements to launch new products.

You will lead risk management for projects, including risk analysis and development of sound mitigation strategies.

You will use quality engineering tools, statistical methods, design development methods, process development and control methods, and design verification and validation planning to build quality into new products during development.

You will lead HFE activities to develop intuitive and safe new products.

You will lead design validation and verification efforts to ensure new products meet all customer user needs.

You will support process validation for new product development to ensure long-term product quality.

You will develop and create procedures for incoming, in-process and final inspection of components and finished goods.

You will partner with post market development teams to ensure quality system requirements are being met.

You will be the voice of Quality in a cross-functional team.

You will foster strong relationships through open communication, respect and trust.

You will evaluate project tangibles for technical competence and compliance to ensure we are delivering robust products.

You will support complaint investigation and post market activities.

You may lead NC & CAPA, which require expertise in problem solving and root cause analysis.

What you need

Bachelor's Degree in Mechanical Engineering, Electrical Engineering, Biomedical Engineering or equivalent discipline is required.

A minimum of 2 years of experience in a Technical Engineering or Quality Engineering position within an R&D or manufacturing environment

A minimum of 1 year of experience as an AQE or Design Quality Engineer is highly preferred

Previous experience in a regulated environment preferred

ASQ CQE, CRE, CSSBB or equivalent course work / experience desirable

Proficient understanding of Med Device manufacturing processes highly preferred

Familiarity with ISO 13485, GDP, GMP preferred

Our benefits

Our total rewards offering varies by country but often includes bonuses; commissions; healthcare; insurance benefits; retirement programs; stock based plans; paid time off plans; family and parenting leaves; tuition reimbursement; wellness programs; onsite fitness centers and cafeterias; discount purchase programs; and service and performance awards – not to mention various social and recreational activities.

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 at https://careers.stryker.com/referrals/

Company info

Stryker.
Website : http://www.stryker.com