Quality Manager (Engineer background)

Title: Quality Manager (Engineer background)

Status: Full-time, Exempt

Reports to: Director of R&D

Our team is dedicated to developing technologies that will change the medical device landscape. If you are seeking an opportunity to make a real impact on patients' lives and grow your career NuevoSono is the right place for you.

Role Summary

NuevoSono, a T45 Labs portfolio company, is seeking a highly motivated Quality Engineer to support the production of groundbreaking medical devices. The position is hands-on and requires the ability to be productive in a fast-moving environment. A successful candidate will be a team player with an entrepreneurial drive to grow within our company. The candidate is expected to have expertise in catheter manufacturing to support documentation development, process improvements, and risk assessment. This role will be responsible for creating and maintaining documents within our Quality System, including: Manufacturing Process Instructions (MPIs), work instructions, test methods, design verification (DV) protocols, and reports. The candidate will play a hands-on role in improving manufacturing workflows, developing fixtures, identifying process gaps, and optimizing testing procedures.

Responsibilities

• Lead the development and implementation of quality system policies, procedures, and documents.
• Provide expertise and guidance related to ISO 13485 and FDA 21 CFR Part 820.
• Work directly with product development and manufacturing to train and ensure QMS compliance.
• Support process validation study design and execution.
• Coordinate, review, and approve final sterile product lot release.
• Perform internal and external supplier audits/inspections.
• Support combination product regulatory filings and clinical trials (US and OUS).
• Collect and report key quality metrics to management.

Documentation & Compliance

• Develop and maintain MPIs, work instructions, test methods, protocols for DV, and reports to ensure compliance with quality and regulatory standards.
• Support the creation and revision of Standard Operating Procedures (SOPs) related to catheter manufacturing and testing.
• Ensure proper documentation control in alignment with FDA, ISO 13485, and ICH guidelines.

Manufacturing & Process Improvement

• Identify and fill gaps in manufacturing and documentation processes.
• Develop and refine workflows for manufacturing and testing, ensuring efficiency and compliance.
• Design and implement fixtures, tooling, and process improvements to enhance catheter production.
• Conduct root cause analysis and corrective actions (CAPA) to resolve quality issues.

Testing & Risk Assessment

• Develop and validate test methods for catheter components and final assemblies.
• Conduct risk assessments (FMEA, hazard analysis) to proactively identify and mitigate quality risks.
• Collaborate with R&D, Manufacturing, and Regulatory teams to ensure product quality and reliability.

Qualifications

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related field.
• Minimum of 5 years work experience in quality department of a regulated medical industry (preferably with catheters or vascular devices).
• Experience with manufacturing process, process optimization, test development, and equipment validations.
• In depth knowledge of ISO 13485, FDA, ISO medical device regulations, and GMP requirements.
• Excellent oral and written communication skills.
• Proficiency in developing MPIs, work instructions, test methods, protocols, and validation reports.
• Proficiency in risk management (ISO 14971) and process improvement methodologies.
• Ability to work cross-functionally to identify and close process gaps.

Location & Compensation

This position is required to be on-site for the first six months to support in-person collaboration and team activities, and can possibly become hybrid later on.

T45 Labs is committed to fair and equitable pay practices, and compensation may include bonuses, equity, and benefits as part of the total rewards package.

The anticipated salary range for this position is $118,000 - $160,000 annually, based on San Francisco Bay Area market data. Actual compensation will vary depending on factors such as experience, skills, and geographic location.

Equal Employment Opportunity Statement

T45 Labs and its affiliated companies are Equal Opportunity Employers. We celebrate diversity and are committed to creating an inclusive environment for all employees. Employment decisions are based on qualifications, merit, and business needs.

We do not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other legally protected status.

Third-Party Recruiter Notice

We do not accept unsolicited resumes from staffing agencies or recruiters without a signed agreement in place. Any resumes submitted without such an agreement will be considered property of T45 Labs and/or its affiliated companies, and no fees will be paid if the candidate is hired. If your agency or firm would like to officially submit candidates for any of our posted roles, please email careers@t45labs.com