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 vital role in leading quality engineering initiatives for digital products. This position is responsible for ensuring compliance with regulatory requirements and quality standards throughout the product development lifecycle. The ideal candidate will collaborate cross-functionally to establish and implement quality systems, protocols, and best practices, driving the innovation and excellence of Stryker's digital solutions while contributing to patient safety and satisfaction.

Job Responsibilities

• Lead quality engineering activities related to digital health products, ensuring alignment with corporate quality standards and regulatory requirements.
• Develop, implement, and maintain design control processes, including risk management, verification and validation, and design reviews.
• Collaborate with cross-functional teams to define and document quality requirements for digital products and services.
• Conduct audits and assessments of product development processes to identify areas for improvement and ensure compliance.
• Provide leadership and mentorship to junior quality engineers, fostering a culture of quality and continuous improvement.
• Utilize statistical methodologies for data analysis to inform design decisions and validate product performance.
• Stay abreast of industry trends, regulatory changes, and technological advancements to enhance product quality and performance.

Qualifications

• Bachelor’s degree in Engineering, Quality Assurance, or a related field; a Master's degree is preferred.
• Minimum of 7 years of experience in quality engineering within the medical device or digital health industry.
• Strong knowledge of ISO 13485, FDA regulations, and other relevant quality standards.
• Proficiency in risk management methodologies, such as FMEA, fault tree analysis, and hazard analysis.
• Exceptional analytical and problem-solving skills, with the ability to interpret complex data and drive actionable insights.
• Experience in digital technologies and software development methodologies, such as Agile or DevOps.
• Effective communication and leadership abilities to interact with diverse teams and stakeholders.

Technologies & Tools

This position utilizes various technologies and tools designed for product development and quality assurance. The candidate will work with software for risk management, data analysis, and quality documentation, including tools such as MATLAB, Minitab, and project management software. Familiarity with electronic quality management systems (eQMS) will also be essential for maintaining compliance and efficient workflow processes.

Ideal Candidates

The ideal candidates for the Principal Design Quality Engineer - Digital role are proactive, detail-oriented individuals with a passion for improving product quality and patient safety. They should demonstrate a strong ability to lead projects, mentor team members, and implement innovative solutions in a fast-paced environment. Strong interpersonal skills and the capability to engage effectively with cross-functional teams are critical to success in this position, along with a strategic mindset and the ability to anticipate challenges and opportunities in the quality engineering landscape.