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 will play a pivotal role in ensuring the quality and compliance of software and digital health products throughout their lifecycle. This position involves collaboration with cross-functional teams to design, implement, and optimize quality processes, applying engineering principles to ensure that products meet regulatory requirements and provide a reliable user experience. The successful candidate will also be responsible for risk management, product validation, and facilitating communication between engineering and quality assurance to promote high standards of quality and performance.

Job Responsibilities

• Lead quality assurance efforts for digital products, ensuring adherence to regulatory standards and internal quality protocols.
• Develop and implement quality plans, methodologies, and processes for the software development lifecycle.
• Perform thorough risk assessments and validation testing to mitigate potential product failures and ensure safety and efficacy.
• Collaborate with product design, engineering, and regulatory teams to integrate quality standards into all phases of product development.
• Conduct audits and inspections to assess compliance with established quality standards and drive continuous improvement initiatives.
• Provide training and mentorship to junior quality engineers, fostering a culture of quality across the organization.
• Utilize metrics and data analysis to identify trends, develop insights, and enhance overall product quality and performance.

Qualifications

• Bachelor’s degree in Engineering, Computer Science, or related field; Master’s degree preferred.
• Minimum of 5 years of experience in quality engineering, particularly within the digital health or medical device sectors.
• Strong knowledge of quality management systems, software validation methodologies, and regulatory requirements (e.g., FDA, ISO 13485).
• Proficient in risk management processes (e.g., ISO 14971) and statistical analysis tools.
• Excellent communication skills, with the ability to convey complex technical information to diverse audiences.
• Proven leadership abilities and experience in managing cross-functional teams.
• Certifications in quality engineering or project management (e.g., CQE, PMP) are a plus.

Technologies & Tools

The Principal Design Quality Engineer will utilize a variety of technologies and tools to support software development and quality assurance processes. Familiarity with Agile development methodologies, quality management software (such as Jira or HP ALM), continuous integration/continuous deployment (CI/CD) pipelines, and statistical analysis tools (such as Minitab) is essential. Knowledge in software programming languages may be beneficial in understanding development processes and enhancing quality assurance activities.

Ideal Candidates

The ideal candidate for the Principal Design Quality Engineer position should exhibit strong analytical and problem-solving skills, with an inherent attention to detail. They should be proactive, adaptable, and able to work effectively in a fast-paced, team-oriented environment. Exceptional interpersonal skills to foster collaboration between departments and the ability to mentor others are vital. Moreover, a passion for innovation in digital health and an unwavering commitment to quality will be pivotal for success in this role.