Senior Design Quality Engineer - NPD Advanced (Hybrid)
Company: Stryker
Location: Flower Mound
Posted on: May 26, 2023
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Job Description:
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
We are proud to be named one of the World's Best Workplaces and a
Best Workplace for Diversity by Fortune Magazine! Learn more about
our award-winning organization by visiting stryker.com
Our benefits include bonuses; commissions; healthcare; insurance
benefits; retirement programs; stock based 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.
Stryker is hiring a Senior Design Quality Engineer, NPD Advanced
(Hybrid) in the Dallas, TX , area to join our Communications
Quality Assurance team !
We are looking for a hands-on engineer passionate about innovation,
being part of new product development, and ensuring product
quality. In this role, you will focus on new product development
for our surgical light, surgical table, and boom portfolios.
Experience the future of the OR: Stryker Communications
We are passionate about driving innovation and working with our
customers to improve healthcare through high-quality product
releases! This role will have the opportunity to engage with
customers in the operating room (OR) setting to understand customer
needs and challenges so that they can effectively drive patient
safety and surgical workflow efficiency solutions to our customers
through new product releases.
Work Flexibility: Hybrid. This role requires reasonable proximity
to our Stryker facility in Flower Mound, TX. You should be
comfortable working 3-4 days onsite.
Who we want:
Curious learners. Engineers who seek out cutting-edge research and
information to expand and enhance their ability to design medical
devices .
User-focused creators. Engineers who design with the user in mind,
developing medical devices that help change patients' lives.
Collaborative partners. People who build and leverage
cross-functional relationships to bring together ideas, data, and
insights to drive continuous improvement in functions.
What you will do :
Partner with R&D and other cross-functional teams to define
design requirements and develop manufacturing processes to support
new product development projects.
Lead risk management activities for new product development
projects and to ensure the highest level of product quality.
Partner with cross-functional project teams to lead product and/or
user design and validation development activities.
Develop quality engineering documentation to support new product
development processes and regulatory submissions.
Evaluate overall residual risk for products prior to launch and
present final risk/benefit justification to executive
leadership.
Present risks associated with the product use during Design Reviews
and track the design, documentation, and manufacturing process
mitigate those issues throughout the development process.
Partner with cross-functional project teams to define design
verification and validation test requirements that ensure
appropriate objective evidence is available to support the
acceptance criteria.
Utilize standard statistical analysis and problem-solving
techniques to determine product acceptance limits, establish
process parameters, resolve quality problems, etc.
Develop, review, and approve inspection plans, routers, and product
drawings for new products.
Support product design transfers to internal and/or external
manufacturing facilities.
Provide support and direction for other Quality Engineers.
Evaluate predicate products for relevant quality issues that may
impact new product development projects.
Analyze and define critical quality attributes for product and
process through risk analysis techniques.
Participate in collection of initial market feedback on new
products and address early concerns.
Contribute to the completion of final design verification and
validation reports by providing concise conclusions with
statistical validity and graphical support.
What you need :
Required:
Bachelor's Degree in Mechanical Engineering, Electrical
Engineering, Biomedical Engineering, or a related engineering
discipline. Mechanical Engineering strongly preferred.
Minimum of 2+ years of experience within a regulated industry.
Preferred:
4+ years of Design Quality Engineering experience strongly
preferred.
Previous experience working with OEMs to launch new medical
devices, highly desired.
Technical experience should include but not limited to: New Product
Development, Product Quality, Risk Assessment, Risk Management,
Design Assurance, Design Verification and Validation, Defect
Reviews, Product Reliability and Durability.
Ability to influence and lead others without direct authority.
Demonstrated ability to effectively work cross-functionally with
other departments, including Advanced Operations, Product
Development, Regulatory Affairs, and Marketing.
Demonstrated ability to advocate for product excellence and
quality.
Preferred experience with medical device product development
lifecycle, including risk management and design/process
verification and validation.
Thorough knowledge and understanding of US and International
Medical Device Regulations preferred.
Experience in interacting with regulatory agencies (FDA, MoH, TUV,
etc.)
Experience in working in a compliance risk situation.
Strong knowledge of Quality Concepts
Must possess strong project management skills as well the ability
to manage multiple tasks simultaneously.
Strong in critical thinking and "outside the box" thinking along
with highly developed problem-solving and analytical skills.
Travel
About Stryker
Stryker is one of the world's leading medical technology companies
and, together with our customers, is driven to make healthcare
better.
The company offers innovative products and services in Medical and
Surgical, Neurotechnology, Orthopedics, and Spine that help improve
patient and healthcare outcomes. Alongside its customers around the
world, Stryker impacts more than 100 million patients annually.
More information is available at stryker.com
(http://www.stryker.com.)
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.
Keywords: Stryker, Flower Mound , Senior Design Quality Engineer - NPD Advanced (Hybrid), Engineering , Flower Mound, Texas
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