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.

Overview

The Principal Design Quality Engineer - Digital at Stryker is a pivotal role focused on ensuring that digital health products meet the highest standards of quality and compliance throughout the design lifecycle. The successful candidate will collaborate cross-functionally with product development teams to establish and uphold quality assurance processes, contribute to risk management activities, and implement continuous improvement initiatives. Responsibilities will encompass the review and approval of design documentation, leading investigations for product failures, and mentoring junior engineers to foster a culture of quality within the organization.

Job Responsibilities

• Lead the development and implementation of quality assurance strategies for digital health product designs.
• Review and approve design documentation including specifications, verification, and validation plans
• Conduct risk management activities, including FMEA and usability risk assessments, to identify and mitigate potential hazards.
• Collaborate with cross-functional teams to ensure compliance with applicable regulatory requirements.
• Drive continuous improvement initiatives aimed at enhancing product quality and engineering processes.
• Investigate product failures and facilitate root cause analysis to determine corrective actions.
• Mentor and guide junior design quality engineers in best practices and regulatory compliance.
• Stay abreast of industry trends and regulatory changes that could impact digital health products.

Qualifications

• Bachelor's degree in Engineering, Computer Science, or a related field.
• A minimum of 7 years of experience in quality engineering, with a focus on digital products preferred.
• Strong knowledge of medical device regulations including FDA, ISO 13485, and IEC 62304 compliance.
• Proven experience with quality tools and methodologies such as Six Sigma, Root Cause Analysis, and FMEA.
• Excellent analytical, problem-solving, and decision-making skills.
• Strong communication skills and the ability to collaborate effectively in a cross-functional team environment.
• Certification in Quality Engineering (CQE) or equivalent is an advantage.

Technologies & Tools

The Principal Design Quality Engineer - Digital will utilize various technologies and tools, including software for quality management systems (QMS), statistical analysis tools, risk management software, and design verification tools. Familiarity with documentation control systems, electronic lab notebooks, and collaboration tools such as Jira and Confluence is essential to facilitate effective project management and communication.

Ideal Candidates

Ideal candidates for this role will possess strong leadership qualities with a genuine passion for ensuring product quality in digital health applications. They should exhibit a proactive mindset, enabling them to identify potential quality issues early in the design process. Exceptional communication skills and a collaborative spirit are essential, allowing for productive interaction across diverse teams. Candidates should be detail-oriented, analytical thinkers with a continuous improvement approach, motivated to drive initiatives that elevate product quality standards within the organization.