Find a job 
Featured Companies 
Featured Universities 
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 competitive pay, career growth opportunities, and a collaborative work environment.
- Why this job: Make a real impact on patient safety while working with cutting-edge technology.
- Qualifications: Bachelor's in Engineering and 2+ years in a regulated environment required.
- Other info: Ideal for those passionate about quality and innovation in healthcare.
The predicted salary is between 48000 - 72000 £ per year.
Stryker is hiring a Senior Design Quality Engineer in Belfast, 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.
#J-18808-Ljbffr
Senior Design Quality Engineer employer: HIRANI
Contact Detail:
HIRANI Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Design Quality Engineer
✨Tip Number 1
Familiarise yourself with the specific quality management systems used in the medical device industry. Understanding these systems will not only help you during interviews but also demonstrate your commitment to quality and compliance.
✨Tip Number 2
Network with professionals in the medical device sector, especially those who work at Stryker or similar companies. Engaging in conversations about current trends and challenges can provide valuable insights and may even lead to referrals.
✨Tip Number 3
Stay updated on the latest regulations and standards in the medical device industry. Being knowledgeable about recent changes can set you apart as a candidate who is proactive and well-informed.
✨Tip Number 4
Prepare to discuss specific examples of how you've contributed to quality improvement initiatives in past roles. Highlighting your hands-on experience with risk management and validation strategies will resonate well with the hiring team.
We think you need these skills to ace Senior Design Quality Engineer
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities and requirements of the Senior Design Quality Engineer position at Stryker. 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've contributed to product safety risk management or quality improvement initiatives.
Showcase Technical Skills: Detail your technical skills related to medical devices, such as knowledge of DFMEA, risk assessments, and validation strategies. 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 outlines your qualifications but also conveys your passion for quality engineering in the medical device industry. Discuss how you can contribute to Stryker's mission of delivering high-quality products.
How to prepare for a job interview at HIRANI
✨Understand the Medical Device Landscape
Familiarise yourself with the latest regulations and standards in the medical device industry. Being able to discuss how these impact design quality will show your depth of knowledge and commitment to compliance.
✨Prepare for Risk Management Discussions
Be ready to talk about your experience with risk management activities, particularly in relation to DFMEA and product hazard analysis. Highlight specific examples where you've successfully identified and mitigated risks in previous projects.
✨Showcase Your Quality Improvement Initiatives
Think of instances where you've led or contributed to quality improvement initiatives. Discuss the methodologies you used and the outcomes achieved, as this demonstrates your proactive approach to enhancing product quality.
✨Engage with Cross-Functional Teams
Since the role involves working within cross-functional teams, prepare to share experiences where you've collaborated effectively with other departments. Emphasise your communication skills and ability to advocate for quality within diverse teams.
