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 plays a critical role in ensuring that our digital medical devices meet the highest standards of quality and safety. This position entails overseeing the design quality processes throughout the product lifecycle, conducting comprehensive risk assessments, and collaborating with cross-functional teams to drive compliance with regulatory standards. The ideal candidate will be responsible for developing quality strategies, executing validation plans, and leading initiatives aimed at continuous improvement in the quality management system.

Job Responsibilities

• Develop and implement quality assurance strategies for digital products in alignment with regulatory requirements.
• Conduct risk management assessments and ensure compliance with ISO 14971 standards.
• Lead product design reviews and provide quality assurance input during all phases of the product lifecycle.
• Collaborate with engineering and product management teams to define, analyze, and document quality metrics.
• Oversee validation activities, including verification and validation (V&V) processes, ensuring effective protocols are in place.
• Drive initiatives for continuous improvement within the Quality Management System (QMS) and establish best practices.
• Prepare for and participate in audits, providing clarity on quality intelligence relative to design controls.
• Mentor and guide junior engineers and quality professionals in best practices for design quality engineering.

Qualifications

• Bachelor's degree in Engineering, Quality, or a related field; Master's degree preferred.
• A minimum of 5 years of experience in Design Quality Engineering within the medical device industry.
• Strong knowledge of ISO 13485 and FDA regulations pertaining to medical devices.
• Proven experience with risk management processes and tools, particularly ISO 14971.
• Demonstrated ability in leading cross-functional teams in a digital product development environment.
• Expertise in product validation and quality assurance methodologies.
• Strong analytical thinking and problem-solving skills.
• Excellent communication and technical writing abilities.

Technologies & Tools

The Principal Design Quality Engineer at Stryker will utilize a range of technologies and tools to facilitate quality assurance functions. Proficiency in quality management software, statistical analysis tools, risk management tools, and electronic document management systems is essential. Familiarity with simulation and modeling software, as well as experience with project management tools, will greatly enhance collaboration across teams.

Ideal Candidates

Ideal candidates for the Principal Design Quality Engineer - Digital role will possess a proactive mindset and a passion for quality in healthcare technology. They should demonstrate strong leadership capabilities and an ability to work collaboratively in a fast-paced, remote working environment. Attention to detail, adaptability, and a commitment to continuous improvement are crucial traits. A focus on customer-centric solutions and a strong ethical foundation in compliance and regulatory adherence will ensure alignment with Stryker's core values.