Senior Design Quality Engineer (P-4576)

The Senior Design Quality Engineer at 10x Genomics will take on several vital responsibilities, including developing quality frameworks that meet ISO 13485 standards, managing design control activities for new product development, and collaborating with cross-functional teams. A significant part of this role includes providing quality engineering support for reagent and assay development projects, conducting design reviews, and identifying potential quality risks throughout the product lifecycle.

To qualify for the Senior Design Quality Engineer role at 10x Genomics, candidates should possess a Bachelor's or Master's degree in a relevant discipline such as Biology or Biomedical Engineering. Additionally, a minimum of 7 years of experience in quality engineering with a focus on design control in the life sciences sector is essential. Proficiency in ISO 9001 and ISO 13485 standards and proven leadership in managing quality processes are also key requirements.

The Senior Design Quality Engineer at 10x Genomics contributes significantly to product development by ensuring compliance with established quality standards and facilitating robust design control processes. This role is crucial in the risk management, design verification, and validation activities for innovative products, thereby ensuring that they not only meet regulatory requirements but also align with customer needs.

To succeed as a Senior Design Quality Engineer at 10x Genomics, candidates should possess excellent problem-solving skills alongside a strong understanding of risk management principles. Effective communication and interpersonal abilities are also critical, enabling collaboration with diverse teams and influencing stakeholders at all levels. Creativity and flexibility in approach are highly valued in tackling challenges encountered during product development.

Working as a Senior Design Quality Engineer at 10x Genomics presents numerous opportunities for professional growth. The role allows for continuous learning through engagement with industry best practices and upcoming trends. Moreover, the chance to participate in audits and collaborate with various departments not only sharpens technical skills but also enhances leadership abilities, paving the way for potential career advancement within the organization.

When discussing your experience with ISO 13485 standards, focus on specific projects where you applied these standards to ensure product quality in the life sciences. Highlight your participation in design control activities, any audits you’ve been involved in, and how you've contributed to achieving compliance during product development cycles.

In your response, share examples of projects where you developed or improved design control processes. Discuss the steps you took, the challenges faced, and the outcomes achieved. Emphasize your collaborative efforts with cross-functional teams and how your contributions ensured project success.

Discuss the various risk management tools you've utilized, such as FMEA or fault tree analysis, and how you incorporated them into your design processes. Provide specific instances where your risk management strategies effectively mitigated potential issues, demonstrating your proactive approach to quality engineering.

Explain your strategy for ensuring quality during the transition phase. Mention your approach to communication with manufacturing teams, the importance of quality documentation, and any specific tools or practices you’ve employed to oversee compliance and smooth transitions in product lifecycle management.

Use a behavioral response format to share a specific example, detailing the issue, the steps you took to analyze and resolve it, and the outcome. Showcase your problem-solving and analytical skills, emphasizing collaborative efforts with team members to successfully address the quality challenge.

Describe your methodology for conducting design reviews, including the criteria used to evaluate design outputs against inputs. Highlight how you encourage team participation, foster open discussions, and ensure that all stakeholders are aligned with product goals, ensuring that designs meet customer and regulatory expectations.

Discuss your commitment to continuous learning, such as attending industry conferences, participating in relevant training, and reading up-to-date literature. Share how you integrate this knowledge back into your work at 10x Genomics, enhancing quality systems and practices within your team.

Articulate your experience in managing DHFs, detailing the key components you ensure are included, how you maintain file integrity, and defend compliance during audits. Provide examples of how a well-organized DHF has played a critical role in supporting a project’s regulatory submissions.

Talk about your belief that effective teamwork is vital in quality engineering, especially in cross-functional projects. Illustrate how collaboration with R&D, Manufacturing, and other stakeholders enhances product reliability and quality, using specific examples from your experience to demonstrate the impact of collaboration.

Emphasize your balance between adhering to quality standards while encouraging innovation. Provide insights into how you help teams think creatively while meeting regulatory compliance, sharing specific instances where this balance has led to successful product development outcomes.