Find a job 
Featured Companies 
Featured Universities 
For Companies At a Glance
- Tasks: Support the Quality Engineering team in developing and maintaining innovative ocular medical devices.
- Company: Join Glaukos, a leader in ocular medical technology, dedicated to improving patient outcomes.
- Benefits: Enjoy a collaborative work environment with opportunities for professional growth and development.
- Why this job: Make a real impact in healthcare by ensuring the quality of life-changing medical devices.
- Qualifications: Bachelor's degree and 5+ years in medical device or semi-regulated industry required.
- Other info: Experience with programming languages and quality assurance processes is essential.
The predicted salary is between 48000 - 72000 £ per year.
GLAUKOS – SR. QUALITY ENGINEER (SOFTWARE/R&D QUALITY) BURLINGTON, MA
How will you make an impact?
The Senior Quality Engineer I, Software position supports the Quality Engineering (QE) team throughout the full product lifecycle of innovative ocular medical devices. Responsibilities include executing design control deliverables, risk management activities, ensuring Design History File compliance, and supporting assessment and implementation of design changes for already approved medical devices. This role involves developing new software designs and maintaining and enhancing existing products from a software perspective.
What will you do?
Under general managerial supervision, collaborates with development teams in the following areas:
Design Control and Risk Management
- Support the development of medical devices with software by working with application developers and product teams.
- Assist in the development and qualification of software development tools and services.
- Review software test cases and test runs to support design verification and validation activities.
- Review Software Design Documentation.
- Participate in risk management activities to ensure effective product development and operational compliance with ISO 14971, IEC 62304, and ANSI/AAMI SW96.
- Support changes to product designs.
Quality System
- Assist in engineering change order preparation and review.
- Help in periodic reviews of quality system procedures.
- Support QE CAPA owners with task follow-up.
- Assess and improve quality system processes through data monitoring and trend analysis.
- Participate in internal audits and conduct audits as needed.
Other Duties as Assigned
Perform additional duties and projects to support R&D, Operations, Production, Engineering, Clinical, and Regulatory goals.
How will you get here?
- Bachelor\’s degree required.
- 5+ years in medical device or a semi-regulated industry; 8+ years preferred.
- Strong knowledge of medical device manufacturing and software development.
- Familiarity with GMP, ISO 13485, ISO 14971, EU MDD/MDR, GDPR, 21 CFR Part 820, ISO 62304, and IEC 60601 software requirements.
- Expertise in medical product quality assurance, including test protocols and statistical techniques.
- Proficiency in programming languages such as C++, Java, or Python, and experience with software development tools like version control, bug tracking, and automated testing tools.
- Excellent documentation skills, attention to detail, and accuracy.
- Strong team player with good communication skills.
- Organized with the ability to coordinate activities across departments and vendors.
- Emerging leadership qualities demonstrated through performance and accomplishments.
- Strategic thinking and industry understanding in project execution.
- Proficient in data entry and typing skills.
- Experience with ERP systems is required.
#J-18808-Ljbffr
Senior Design Assurance Engineer I, Software employer: DaVita Inc.
Contact Detail:
DaVita Inc. Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Design Assurance Engineer I, Software
✨Tip Number 1
Familiarise yourself with the specific regulations and standards mentioned in the job description, such as ISO 14971 and IEC 62304. Understanding these frameworks will not only help you in interviews but also demonstrate your commitment to quality assurance in medical devices.
✨Tip Number 2
Network with professionals in the medical device industry, especially those who work in quality engineering roles. Attend relevant conferences or webinars to connect with potential colleagues and learn more about the latest trends and challenges in software quality assurance.
✨Tip Number 3
Brush up on your programming skills, particularly in languages like C++, Java, or Python. Being able to discuss your technical expertise confidently during interviews can set you apart from other candidates.
✨Tip Number 4
Prepare to discuss your experience with quality systems and how you've contributed to process improvements in previous roles. Be ready to share specific examples that highlight your problem-solving skills and attention to detail.
We think you need these skills to ace Senior Design Assurance Engineer I, Software
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in medical device software development and quality assurance. Emphasise your familiarity with ISO standards and any programming languages mentioned in the job description.
Craft a Compelling Cover Letter: Write a cover letter that specifically addresses how your skills and experiences align with the responsibilities of the Senior Quality Engineer I position. Mention your experience with design control, risk management, and collaboration with development teams.
Showcase Relevant Projects: Include specific examples of projects where you contributed to software design or quality assurance in medical devices. Highlight your role in ensuring compliance with regulations and improving quality systems.
Proofread and Edit: Before submitting your application, thoroughly proofread your documents for any spelling or grammatical errors. Ensure that all information is clear, concise, and professional to make a strong impression.
How to prepare for a job interview at DaVita Inc.
✨Showcase Your Technical Expertise
Make sure to highlight your experience with programming languages like C++, Java, or Python during the interview. Be prepared to discuss specific projects where you applied these skills, especially in the context of medical device software development.
✨Demonstrate Knowledge of Regulatory Standards
Familiarity with standards such as ISO 13485, ISO 14971, and IEC 62304 is crucial for this role. Prepare examples of how you've ensured compliance with these regulations in past projects, as this will show your understanding of quality assurance in the medical device industry.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving abilities in real-world situations. Think about challenges you've faced in design control or risk management and how you overcame them. This will demonstrate your critical thinking and strategic approach.
✨Emphasise Team Collaboration Skills
As this role involves working closely with various teams, be ready to discuss your experiences in cross-departmental collaboration. Highlight instances where your communication and organisational skills led to successful project outcomes.
