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 be responsible for ensuring that the quality standards and regulatory requirements for digital medical devices are met throughout the design process. This role involves collaborating with cross-functional teams to establish and implement design controls, risk management, and verification/validation strategies. The Principal Design Quality Engineer will also play a crucial role in mentoring junior engineers and helping lead initiatives to continuously improve quality assurance processes within the organization.

Job Responsibilities

• Lead quality engineering efforts in the design and development of digital medical devices.
• Establish and maintain design control processes in accordance with regulatory standards.
• Conduct risk assessments and implement risk management strategies during the design phase.
• Collaborate with design, software, and hardware engineering teams to ensure compliance with quality standards.
• Coordinate and execute verification and validation activities for digital products.
• Review and approve technical documentation including design specifications, test plans, and reports.
• Mentor and train junior quality engineers, fostering a culture of quality throughout the organization.
• Support audit readiness and facilitate internal and external quality audits.

Qualifications

• Bachelor’s degree in Engineering, Computer Science, or a related field; Master’s degree preferred.
• A minimum of 5 years of experience in quality engineering within the medical device industry.
• Strong understanding of design controls, risk management, and regulatory compliance standards (FDA, ISO 13485, etc.).
• Proficiency in creating and reviewing engineering documentation.
• Experience with electronic/software development life cycle and methodologies.
• Excellent problem-solving abilities and attention to detail.
• Strong communication skills, both verbal and written, with the ability to influence cross-functional teams.

Technologies & Tools

The Principal Design Quality Engineer will utilize various technologies and tools to facilitate quality assurance processes. Key tools include quality management software, Statistical Process Control (SPC) software, and requirements management software. Familiarity with design tools such as CAD and simulation software, as well as knowledge of programming languages relating to digital device development, may be beneficial.

Ideal Candidates

Ideal candidates for the Principal Design Quality Engineer position will possess a combination of technical expertise and strong interpersonal skills. They should exhibit a passion for quality and a proactive approach to problem-solving. The ability to effectively communicate complex concepts to diverse audiences and collaborate within cross-functional teams is essential. A focus on continuous improvement and an unwavering commitment to regulatory compliance are also key characteristics of successful candidates in this role.