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Principal Design Quality Engineer
Location
United States
Posted
10 days ago
Salary
Not specified
No structured requirement data.
Job Description
Role Description
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.
- 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.
Qualifications
- Bachelorโs 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.
Job Requirements
- Bachelorโs 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.
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