Principal Design Quality Engineer - Digital (Remote)

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Job Overview

The Principal Design Quality Engineer - Digital at Stryker will play a pivotal role in ensuring the quality and compliance of digital health technologies. This position requires overseeing and influencing the product development process from a quality perspective, ensuring that digital solutions adhere to both regulatory standards and company policies. The individual will collaborate with cross-functional teams, provide leadership in quality assurance practices, and drive initiatives for continuous improvement, ultimately contributing to the creation of safe and effective digital health products.

Job Responsibilities

• Lead quality assurance efforts in the design and development of digital health technologies.
• Establish and maintain quality standards in compliance with regulatory frameworks such as ISO, FDA, or equivalent.
• Evaluate risk management processes associated with digital products and ensure they meet organizational requirements.
• Collaborate with engineering and development teams to integrate quality practices into the product lifecycle.
• Conduct internal audits and process evaluations to ensure compliance and identify areas for improvement.
• Provide mentorship and guidance to junior engineers and team members on quality assurance methodologies.
• Participate in Product Development Process (PDP) milestones; review design documentation and validation activities.
• Engage in customer feedback analysis to refine and improve product offerings continuously.

Qualifications

• Bachelor's degree in Engineering, Quality, or a related field; a master's degree is preferred.
• A minimum of 5 years of experience in quality engineering within the medical device or digital health industry.
• Comprehensive knowledge of regulatory requirements and standards affecting medical devices, particularly regarding software validation.
• Proficient in risk management methodologies including ISO 14971.
• Strong analytical skills with proficiency in quality tools (e.g., Six Sigma, FMEA, Root Cause Analysis).
• Exceptional communication and leadership abilities, with experience leading cross-functional teams.
• Certification in quality engineering (e.g., CQE, CQA) is highly desirable.

Technologies & Tools

The Principal Design Quality Engineer - Digital will utilize various technologies and tools, such as statistical software for data analysis, project management tools (e.g., JIRA, Trello), and quality management systems (QMS) specific to the medical device industry. Proficiency in software validation tools and frameworks, as well as familiarity with programming languages pertinent to digital solutions, will be integral to the role.

Ideal Candidates

Ideal candidates for this position will be detail-oriented individuals with a strong commitment to quality excellence. They should demonstrate critical thinking skills, enabling them to navigate complex regulatory landscapes while effectively communicating with diverse teams. The successful candidate will possess a collaborative spirit, fostering constructive relationships and inspiring others to engage in quality assurance best practices. Their proactive approach to problem-solving and continuous improvement will contribute to the overarching goals of Stryker in delivering cutting-edge digital health products.