Quality Engineer

Quality Engineer

Status: Full-time, Exempt

Reports to: Sr. Director of R&D

About the Role

VahatiCor, a T45 Labs portfolio company, is seeking a highly motivated Quality Engineer with direct catheter device experience and proven ISO 13485 expertise to support the production of groundbreaking medical devices. This is a hands-on role focused on catheter manufacturing, documentation development, process improvement, testing, and risk assessment.

Key Responsibilities

- Develop and maintain Quality System documentation including MPIs, SOPs, work instructions, test methods, protocols (DV), and validation reports.
- Ensure compliance with FDA 21 CFR Part 820, ISO 13485, GMP, and ICH guidelines.
- Support combination product regulatory filings and clinical trials (US and OUS).
- Assist in sterile product lot release documentation.
- Participate in internal and external audits, inspections, and supplier quality assessments.
- Partner with R&D, engineering, and manufacturing to integrate quality standards across the product lifecycle.
- Identify and help close gaps in manufacturing and documentation processes.
- Support development and refinement of workflows for manufacturing and testing.
- Assist in the design and implementation of fixtures, tooling, and process improvements to enhance catheter production.
- Conduct root cause analysis and support CAPA implementation to resolve quality issues.
- Contribute to the development and validation of test methods for catheter components and final assemblies.
- Perform 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.
- Verify that all product releases meet defined quality criteria before market launch.

Qualifications

- Bachelor’s degree in Mechanical, Biomedical, or related Engineering discipline; or equivalent technical background.
- 5+ years of Quality experience in the regulated medical device industry, with direct hands-on catheter manufacturing and testing experience.
- Proven, practical expertise in ISO 13485 implementation and compliance, plus strong knowledge of FDA 21 CFR Part 820, GMP, and ISO 14971 risk management.
- Experience in process optimization, test method development, equipment validation, and regulatory compliance.
- Proficiency in developing MPIs, work instructions, test methods, protocols, and validation reports.
- Strong organizational and communication skills, with the ability to manage multiple priorities in a dynamic environment.
- Hands-on, startup mentality with a proactive approach to problem-solving and continuous improvement.
- Ability to work cross-functionally to identify and close process gaps.

Eligibility

Candidates must be legally authorized to work in the United States without the need for current or future visa sponsorship. We are currently unable to sponsor H-1B visas.

Location & Compensation

This is an onsite role based in Santa Clara, CA, and is open to candidates living within a reasonable commuting distance of our office.

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 of this position is $132,000 - $178,000 annually, based on San Francisco Bay Area market data. Actual compensation will vary depending on factors such as years of experience and skills.

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 [email protected].