Principal Design Quality Engineer - Digital (Remote)

This job was posted over 30 days ago, so it has most likely closed. See newer jobs like it.

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 pivotal role in ensuring the quality and reliability of digital health products. This position encompasses responsibility for establishing and maintaining quality assurance processes, compliance with regulatory standards, and collaboration with cross-functional teams to drive product excellence throughout the development lifecycle. The successful candidate will leverage their expertise to enhance product design quality, mitigate risk, and ensure that Stryker's commitment to patient care and safety is upheld in every innovation.

Job Responsibilities

• Develop and implement design quality assurance strategies for digital health products.
• Conduct risk management activities including risk assessments and failure mode effects analysis (FMEA).
• Collaborate with design and engineering teams to establish design verification and validation protocols.
• Review and approve design documentation in compliance with regulatory requirements.
• Lead internal and external audits to ensure adherence to quality standards.
• Provide mentorship and training to junior quality engineers and team members.
• Engage in continuous improvement initiatives to enhance quality processes.
• Liaise with regulatory bodies to align product development with industry standards.

Qualifications

• Bachelor's degree in Engineering, Quality Assurance, or a related field; Master’s degree preferred.
• A minimum of 7 years of experience in quality engineering, with at least 3 years in a leadership role.
• Extensive knowledge of ISO 13485, FDA regulations, and other relevant standards.
• Proficiency in risk management methodologies and design control processes.
• Strong analytical skills and experience with quality management software tools.
• CISQ, ASQ, or other relevant certifications are a plus.
• Excellent communication and interpersonal skills to engage effectively with stakeholders.

Technologies & Tools

This position will utilize a diverse array of technologies and tools essential for quality engineering. Key software may include quality management systems (QMS), statistical analysis tools, and project management software. Candidates should be familiar with digital health technologies, as well as design and simulation software relevant to product development.

Ideal Candidates

The ideal candidates for this role will possess a strategic mindset, a strong commitment to quality, and a passion for improving patient care through digital solutions. They should demonstrate outstanding problem-solving capabilities, the ability to lead and inspire teams, and a collaborative spirit to work effectively across departments. An exceptional attention to detail and a proactive approach to identifying and mitigating risks will set these candidates apart in this critical position at Stryker.