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For Companies At a Glance
- Tasks: Join a dynamic team to ensure top-notch quality in medical device design and development.
- Company: Stryker is a leading medical technology company dedicated to improving healthcare.
- Benefits: Enjoy hybrid work options, professional growth opportunities, and a supportive work culture.
- Why this job: Be part of impactful projects that enhance patient safety and product quality.
- Qualifications: Bachelor's in Engineering and 2+ years in a regulated environment required.
- Other info: Ideal for those passionate about quality in the medical device industry.
The predicted salary is between 48000 - 72000 £ per year.
Position Summary
Senior Design Quality Engineer (Hybrid)
Stryker is hiring a Senior Design Quality Engineer in Redmond-WA, to support our Medical Business. You will work as the Design Quality Engineering partner within a cross-functional product development team to enable timely launch of the highest quality products that meets and exceeds customer and stakeholder expectations in support of a successful product lifecycle of a medical device. You will serve as a representative for the Quality Management System at all times and drive continuous process improvement.
What you will do:
- Participate in the product development process by ensuring that all the quality data streams are fully comprehended and that the voice of the customer, as heard through these data streams (complaints, non-conforming records, verified failures, etc.), is a design input and consideration.
- Lead product safety Risk Management activities, including, characterization and estimation of design risks, which includes both the appropriate control activities and proper identification in downstream design outputs. Develop Risk Management File deliverables including Product Hazard Analysis, design failure modes and effects analysis [DFMEA], Critical to Quality characteristics on specifications, Risk Assessments for issues impacting distributed product, etc.
- Develop validation strategies for projects that are consistent with design validation policies and procedures. Provide technical direction and approval of validation plans, protocols, reports.
- Provide technical direction in optimization of test plans, test methods and sampling.
- Advocate and lead the execution of initiatives & projects to improve Quality throughout the organization
- Establish appropriate field performance trending metrics using standardized reporting mechanisms, analyze results to identify emerging trends and improvement opportunities, and reporting for production and post-production monitoring of new products after launch.
- Provide Quality leadership to drive the timely resolution of quality issues impacting assigned product lines and participate in the CAPA process as task owner/contributor as appropriate and necessary. Advise on risk management investigations for HHE, PFAs, NCs and CAPAs or other post-market issues as needed.
- Participate in internal & external audits with regulatory representatives, providing effective narrative and description of topic of expertise and overview of product development within the Design Controls process.
- As a Senior level engineer, seek out learning opportunities across Stryker to advance technical skills and knowledge and develop subject matter expertise
What you will need:
- Bachelors Degree in Engineering (biomedical engineering preferred)
- 2+ years of experience working in a highly regulated environment, quality, manufacturing, or engineering.
- Strong knowledge of medical device industry policies and regulations.
- Prior experience working with electro-mechanical commodities and embedded software in a product development capacity
- Knowledge of quality tools for process capability, root cause investigation, developing sampling plans, test method validation, or other Quality tasks
- Knowledge of good design practices, specification development, industry standards, etc.
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Senior Design Quality Engineer employer: Stryker Group
Contact Detail:
Stryker Group Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Design Quality Engineer
✨Tip Number 1
Familiarise yourself with the latest regulations and standards in the medical device industry. This knowledge will not only help you during interviews but also demonstrate your commitment to quality and compliance, which is crucial for a Senior Design Quality Engineer role.
✨Tip Number 2
Network with professionals in the medical device field, especially those who work at Stryker or similar companies. Attend industry conferences or webinars to connect with potential colleagues and learn more about the company culture and expectations.
✨Tip Number 3
Prepare to discuss specific examples of how you've contributed to quality improvement initiatives in past roles. Highlight your experience with risk management and validation strategies, as these are key responsibilities for the position.
✨Tip Number 4
Stay updated on the latest trends and technologies in design quality engineering. Being knowledgeable about emerging tools and methodologies can set you apart from other candidates and show your proactive approach to continuous learning.
We think you need these skills to ace Senior Design Quality Engineer
Some tips for your application 🫡
Understand the Role: Before applying, make sure to thoroughly understand the responsibilities and requirements of the Senior Design Quality Engineer position. Tailor your application to highlight relevant experiences that align with the job description.
Highlight Relevant Experience: In your CV and cover letter, emphasise your experience in quality engineering, particularly in regulated environments. Mention specific projects where you contributed to product safety risk management or validation strategies.
Showcase Technical Skills: Detail your technical skills related to medical devices, such as knowledge of DFMEA, risk assessments, and quality tools. Use examples to demonstrate how you've applied these skills in previous roles.
Craft a Compelling Cover Letter: Write a cover letter that not only summarises your qualifications but also conveys your passion for quality engineering in the medical device industry. Discuss how you can contribute to Stryker's mission and values.
How to prepare for a job interview at Stryker Group
✨Understand the Role and Responsibilities
Make sure you thoroughly understand the job description and the key responsibilities of a Senior Design Quality Engineer. Familiarise yourself with terms like Risk Management, DFMEA, and CAPA, as these will likely come up during the interview.
✨Prepare Examples from Your Experience
Think of specific examples from your past work that demonstrate your experience in quality engineering, particularly in regulated environments. Be ready to discuss how you've handled quality issues or led improvement initiatives.
✨Showcase Your Knowledge of Regulations
Since this role involves working within a highly regulated industry, be prepared to discuss your knowledge of medical device regulations and standards. Highlight any relevant certifications or training you have completed.
✨Ask Insightful Questions
Prepare thoughtful questions to ask the interviewer about the company's quality management practices and how they approach product development. This shows your genuine interest in the role and helps you assess if it's the right fit for you.
