Principal Design Quality Engineer at Jobgether – United States
Jobgether
United States, United States
Posted on
NewJob Function:Engineering
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About This Position
Principal Design Quality Engineer
This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Principal Design Quality Engineer in United States.
This role is a senior-level position responsible for ensuring the safety, efficacy, and regulatory compliance of software medical device products. You will serve as the design quality engineering lead across product development teams, overseeing all aspects of design control, risk management, and software verification & validation. This position requires collaboration with cross-functional engineering teams to integrate quality into the software development lifecycle, while maintaining alignment with ISO 13485, IEC 62304, FDA 21 CFR Part 820, and other global standards. You will also lead documentation efforts, maintain the Design History File, and provide guidance on compliance and process improvements. The role offers a highly collaborative, remote-friendly environment, with opportunities to influence quality strategy and mentor other team members. Occasional travel is required for on-site team meetings and cross-functional projects.
Accountabilities:- Lead design quality engineering activities for software medical device projects, ensuring compliance with applicable regulatory standards and internal Quality Management System (QMS).
- Review and approve design documentation including user needs, requirements specifications, architecture, and verification & validation plans and reports.
- Facilitate and maintain risk management activities throughout the product lifecycle in alignment with ISO 14971.
- Provide oversight of software development lifecycle (SDLC) processes, ensuring quality is integrated into agile workflows.
- Participate in design reviews, technical meetings, and software issue triage to assess risks and drive prioritization.
- Maintain accurate Design History Files (DHF) and ensure readiness for audits and regulatory inspections.
- Lead training initiatives to strengthen quality practices across teams and support corrective and preventive actions (CAPA) as needed.
Requirements:
- Bachelors degree in engineering, computer science, or related discipline.
- 12+ years of experience in Design Quality or Quality Engineering within the medical device industry, with a focus on software as a medical device (SaMD).
- In-depth knowledge and practical experience with ISO 13485, IEC 62304, ISO 14971, and FDA 21 CFR Part 820.
- Hands-on experience with modern software development and testing tools such as GitHub, TestRail, and CI/CD pipelines.
- Strong analytical, problem-solving, and attention to detail skills.
- Excellent written and verbal communication skills for effective collaboration in cross-functional, remote teams.
- ASQ certification (CSQE or CQE) is a plus.
- Willingness to travel approximately twice per year to office locations.
Benefits:
- Competitive base salary ($145,000 - $160,000) with 15% target annual bonus, resulting in total target compensation of $166,000 - $184,000.
- Remote-friendly work environment with access to company offices.
- Professional development opportunities and mentorship responsibilities.
- Comprehensive benefits including medical, dental, and vision coverage.
- Paid time off and flexible work arrangements.
- Opportunity to shape quality processes in a rapidly growing, innovative healthcare technology organization.
Why Apply Through Jobgether?
We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
We appreciate your interest and wish you the best!
Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.
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Job Location
United States, United States
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