Principal Design Quality Engineer - Digital (Remote)

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Written by AI from the job title and company, not by Stryker, so some details may not match this job. The employer's own page has the real description.

Job Overview

The Principal Design Quality Engineer - Digital at Stryker will play a pivotal role in ensuring that digital products meet stringent quality and compliance standards. This position involves leading quality assurance processes and collaborating with cross-functional teams throughout the product development lifecycle. The ideal candidate will be responsible for the design and implementation of quality-related strategies, while also ensuring that products not only meet customer expectations but also adhere to regulatory requirements within the medical technology field.

Job Responsibilities

• Lead quality engineering activities related to digital products, ensuring compliance with applicable regulations and standards.
• Develop and implement a risk management process for product design and development.
• Collaborate with design and development teams to establish quality benchmarks and ensure adherence during the development lifecycle.
• Address design quality issues, providing guidance to engineering teams on problem-solving methods.
• Conduct verification and validation activities including test planning, execution, and reporting.
• Participate in design reviews and artifact reviews to identify areas of improvement and enhance quality outcomes.
• Maintain documentation related to design quality processes and report on status to stakeholders.
• Benchmark against industry best practices, contributing to continual process improvement in quality engineering.

Qualifications

• Bachelor's degree in Engineering, Computer Science, or a related field; Master’s degree preferred.
• A minimum of 7 years of quality engineering experience, preferably within the medical device industry.
• Deep knowledge of design control, risk management, and compliance requirements (ISO 13485, FDA regulations).
• Experience in digital product development and quality assurance methodologies.
• Strong analytical skills with a proven ability to troubleshoot complex problems.
• Excellent communication and interpersonal skills to work effectively within a multidisciplinary team.
• Certification in Quality Engineering (CQE, CQA) or equivalent is a plus.

Technologies & Tools

The Principal Design Quality Engineer - Digital will utilize a variety of technologies and software tools to perform job functions effectively. Key tools include quality management systems (QMS), statistical analysis software like Minitab, design control software, and electronic laboratory notebooks (ELN). Familiarity with agile project management tools (such as JIRA or Confluence) and collaboration tools (like Microsoft Teams and Slack) is also essential to facilitate communication and project tracking across global teams.

Ideal Candidates

The ideal candidate for the Principal Design Quality Engineer - Digital position at Stryker will demonstrate outstanding leadership qualities and possess a proactive mindset that fosters collaboration and innovation. A results-oriented approach to quality engineering, coupled with exceptional organizational abilities, will enhance project outcomes. The candidate should be adaptable and capable of managing multiple priorities while maintaining focus on quality assurance principles. Strong ethical standards and a commitment to improving customer satisfaction will be integral to success in this role.