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 is responsible for ensuring the quality and compliance of digital products throughout their lifecycle. This includes leading and executing design verification and validation activities, establishing quality standards, and collaborating with cross-functional teams to drive continuous improvement in product quality. The successful candidate will possess a deep understanding of regulatory requirements, industry best practices, and emerging technologies while leveraging their expertise to contribute to innovative solutions that enhance the safety and performance of digital healthcare products.

Job Responsibilities

• Lead quality engineering initiatives for digital products, ensuring compliance with regulatory and company standards.
• Develop and implement design control processes, including risk management and design verification/validation activities.
• Collaborate with product development teams to define and document quality requirements and specifications.
• Conduct thorough reviews of design documentation to identify quality and compliance gaps.
• Facilitate root cause analysis and corrective action processes for non-conformities in digital products.
• Provide guidance and mentorship to junior quality engineers and other team members.
• Stay updated with industry trends and regulatory changes that may affect product quality.

Qualifications

• Bachelor's degree in Engineering, Quality Assurance, or a related field; Master's degree preferred.
• A minimum of 8 years experience in quality engineering or related roles within the medical device or digital health industry.
• Strong knowledge of ISO 13485, FDA QSR, and other relevant regulatory standards.
• Experience with software and system validation methodologies.
• Proficient in risk management tools and methodologies such as FMEA and ISO 14971.
• Excellent problem-solving skills and the ability to work in a fast-paced environment.
• Strong communication skills with the ability to collaborate across various teams and departments.

Technologies & Tools

The Principal Design Quality Engineer will utilize various technologies and tools essential for quality management and product development, including but not limited to quality management software systems, electronic documentation systems, risk management tools, and data analysis software. Familiarity with systems like Jira, Minitab, and other design control software is advantageous for effective workflow management and analytics.

Ideal Candidates

The ideal candidate for the Principal Design Quality Engineer - Digital at Stryker will be detail-oriented, resilient, and passionate about quality in healthcare technology. They should possess a proactive approach to problem-solving and demonstrate exceptional leadership capabilities. Successful candidates will have a collaborative mindset and the ability to influence and persuade others toward achieving quality objectives. They are expected to be continuous learners, adapting to new challenges and contributing positively to the organization's innovation efforts.