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 will be responsible for ensuring that product design and development processes meet regulatory requirements and company quality standards. This role involves collaborating with multifaceted teams to identify risks in design outputs and ensuring robust quality assurance practices throughout product lifecycles. The Principal Design Quality Engineer will spearhead initiatives aimed at improving product quality, reliability, and compliance, while also contributing to continuous improvement efforts within the organization.

Job Responsibilities

• Lead the implementation of design quality engineering principles and practices throughout product development processes.
• Conduct risk assessments and design reviews to ensure that products meet applicable regulatory standards.
• Collaborate with cross-functional teams to identify and mitigate potential quality issues early in product development.
• Develop and implement validation and verification protocols for digital products.
• Utilize statistical process control and data analysis techniques to monitor product performance and quality metrics.
• Provide mentorship and guidance to junior quality engineering staff.
• Act as a liaison with regulatory authorities, facilitating inspections and audits as necessary.
• Drive continuous improvement initiatives to enhance product quality and reduce development cycle times.

Qualifications

• Bachelor's degree in Engineering, Quality Assurance, or a related field; Master's degree preferred.
• Minimum of 5 years of experience in design quality engineering or a related role within the medical device or digital technology industry.
• Strong knowledge of regulatory requirements, including ISO 13485, FDA QSR, and applicable EU directives.
• Proficient in quality engineering methodologies, including Six Sigma and Lean principles.
• Experience with risk management tools such as ISO 14971 and FMEA.
• Excellent problem-solving skills and a data-driven mindset.
• Strong communication skills, capable of working effectively in cross-functional teams.

Technologies & Tools

The Principal Design Quality Engineer – Digital will utilize various technologies and tools, including Statistical Analysis Software (SAS), Microsoft Office Suite, Project Management Software, validation and verification tools, and Quality Management Systems (QMS). Familiarity with product lifecycle management (PLM) software and electronic quality management systems (eQMS) is also essential for ensuring efficient workflow and documentation control.

Ideal Candidates

An ideal candidate for the Principal Design Quality Engineer – Digital role will possess strong analytical skills combined with a detail-oriented mindset. They should demonstrate a proactive approach to problem-solving, allowing them to effectively identify potential risks and implement strategic solutions. The candidate should also exhibit exceptional communication skills, facilitating collaboration across diverse teams and fostering a culture of quality and compliance. A passion for driving innovation and improving product quality within the healthcare landscape is essential for success in this position.