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 the quality and compliance of innovative digital products and solutions. This position encompasses a broad range of responsibilities, including risk assessment, quality assurance, and collaboration with cross-functional teams throughout the product development lifecycle. As a key member of the quality engineering team, the Principal Design Quality Engineer will leverage expertise in regulatory standards and best practices to drive product excellence and increase customer satisfaction.

Job Responsibilities

• Lead design quality assessments and risk management processes for digital medical devices.
• Develop and implement robust quality assurance strategies aligned with regulatory requirements.
• Collaborate with engineering, product management, and regulatory affairs to ensure product quality is integrated throughout the design and development processes.
• Conduct design reviews and provide feedback to engineering teams on quality-related issues.
• Establish and maintain design control documentation, ensuring compliance with ISO 13485, FDA regulations, and other applicable standards.
• Utilize data analysis to drive continuous improvement initiatives within product quality and process efficiency.
• Provide training and guidance to team members on quality-related topics and best practices.
• Participate in audits and inspections as necessary, demonstrating compliance with quality management systems.

Qualifications

• Bachelor's degree in Engineering, Computer Science, or a related field; a Master's degree is preferred.
• Minimum of 7 years of experience in quality engineering, specifically in regulated medical devices or software.
• Strong knowledge of quality management systems, regulatory requirements, and industry standards.
• Proven experience with risk management methodologies such as ISO 14971.
• Demonstrated ability to lead quality assurance efforts in a cross-functional team environment.
• Excellent analytical, problem-solving, and organizational skills.
• Effective communication and interpersonal skills.
• Certification in Quality Engineering (CQE) or equivalent is a plus.

Technologies & Tools

This role utilizes a variety of technologies and tools pertinent to design quality engineering, including risk management software, statistical analysis tools, project management applications, and electronic quality management systems (EQMS). Familiarity with Agile methodologies and design verification tools is also beneficial to support the digital product development lifecycle effectively.

Ideal Candidates

The ideal candidate for the Principal Design Quality Engineer position is analytical, detail-oriented, and has a strong commitment to quality and compliance. They should possess exceptional communication skills that allow them to articulate complex concepts clearly to both technical and non-technical stakeholders. A proactive approach to problem-solving, along with the ability to work collaboratively in a fast-paced, remote team environment, will make them successful in this dynamic role.