Impress employers and recruiters.
Choose from hundreds of resume examples.
Impress employers and recruiters.
Choose from hundreds of resume examples.
Tailor your resume to this Quality Engineering Lead role.
Rezi rewrites your resume against Echo Neurotechnologies's job description. Free.
Tailor your resume to this Quality Engineering Lead role.
Rezi rewrites your resume against Echo Neurotechnologies's job description. Free.
Don't guess if your resume is good enough.
See how it scores against the Quality Engineering Lead posting at Echo Neurotechnologies — free, in seconds.
Don't guess if your resume is good enough.
See how it scores against the Quality Engineering Lead posting at Echo Neurotechnologies — free, in seconds.
About the Role
As the Quality Engineering Lead, you will champion Design Assurance and Quality Engineering activities throughout the product development lifecycle, ensuring compliance with all applicable standards and regulations. This hands-on role involves building scalable quality systems and executing critical quality engineering tasks across hardware and software domains.
Responsibilities
- Lead and strategize the ongoing implementation of the Quality Management System (QMS) in conformance with US FDA Quality System Regulations, ISO 13485, IEC 62304, and IEC 62366-1.
- Provide quality oversight and support for design and development files (DDFs), including product requirements, software and hardware design specifications, design verification test protocols and reports, risk management files, cybersecurity risk files, biocompatibility and sterilization validation deliverables, and traceability matrices.
- Guide and lead risk management activities, including failure modes and effects analysis (FMEA) and hazards analysis, in alignment with ISO 14971.
- Engage and collaborate with vendors and participate in assessing supplier qualifications.
- Support and participate in internal and external audits, coordinating and providing documentation and evidence of compliance.
- Lead root cause analysis for nonconformances, defects, and CAPAs, issue management, management review, and quality data analysis.
- Mentor junior quality team members and provide quality leadership on projects.
- Foster a collaborative environment, champion continuous improvement initiatives, and promote a quality culture across the organization.
Requirements
- Bachelor’s or Master’s degree in Engineering (e.g., Biomedical, Mechanical, Electrical, or related field).
- 10+ years of quality engineering or medical device development experience from concept development to production release.
- Strong understanding of medical device regulations and standards (FDA, ISO 13485, IEC 62304, ISO 14971, IEC 62366-1) and experience working in a regulated environment.
- Experience with software and hardware V&V activities.
- Experience with AI/ML technology.
- Hands-on experience with risk management tools (e.g., FMEA, risk analysis) and design controls.
- Experience in establishing work relationships across multi-disciplinary teams and with partners in different time zones.
- Experience building trust and demonstrating critical thinking.
- Experience in navigating ambiguity, bringing clarity to complex situations, and thriving in a fast-paced environment.
Skills
- Proficient in working in eQMS tools with impeccable documentation skills.
- Superior written and verbal communication skills to interface with cross-functional teams and regulatory bodies.
- Strong analytical skills.
- Excellent problem-solving skills.
- Exceptional organizational skills and attention to detail.
Location
- Remote
Work Type
- Full-time
Experience Level
- 10+ years
Education Level
- Bachelor's or Master's degree in Engineering
Salary/Compensations
- $200,000—$220,000 USD
Benefits
- Competitive compensation, including stock options.
- Comprehensive benefits package.
- 401(k) program with matching contributions.
About the Company
- Echo Neurotechnologies is an exciting new startup in the Brain-Computer Interface (BCI) space, driving innovation through advanced hardware engineering and AI solutions.
- Our mission is to deliver cutting-edge technologies that restore autonomy to people living with disabilities and improve their quality of life.
- Join a small, dedicated team of knowledgeable and motivated professionals.
- Our early-stage environment offers the opportunity to take ownership of broad decisions with significant and long-lasting impact.
- We emphasize continuous learning and growth, fostering cross-functional collaboration where your contributions are vital to our success.
Equal Opportunity
- Echo Neurotechnologies is an Equal Opportunity Employer (EOE).
- We celebrate diversity and are committed to creating an inclusive environment for all employees.