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Zenflow, Inc. · 15 hours ago

Senior Quality Engineer

South San Francisco, CA

Full-time

Onsite

Mid, Senior Level

$100K/yr - $130K/yr

5+ years exp

Zenflow, Inc. is a privately held medical device company dedicated to improving treatment for patients suffering from urinary obstruction caused by enlarged prostate. They are seeking a highly skilled and motivated Senior Quality Engineer to ensure products meet the highest standards of quality and regulatory compliance, working closely with cross-functional teams in product development, manufacturing, and quality system activities.

Health CareMedical DeviceTherapeutics

Responsibilities

Participate in new and modified product development projects

Establish product specifications and support manufacturing process validation

Develop and review new and revised test methods, validation protocols, and reports (IQ, OQ, PQ)

Conduct risk management activities, including Hazard Analysis, dFMEA, uFMEA, and pFMEA

Maintain and improve the QMS in compliance with FDA, ISO 13485, and other applicable regulatory requirements

Conduct internal and supplier audits to ensure compliance with quality standards

Support external regulatory body audits and inspections

Investigate and resolve non-conformances and product complaints

Lead root cause analysis and implement corrective and preventive actions (CAPA) as appropriate

Track and analyze quality metrics to monitor processes and identify trends and areas for improvement

Qualify new suppliers and manage supplier performance

Conduct supplier audits and supplier re-qualifications to ensure supplier compliance with quality requirements and implementation of corrective actions

Review and maintain post-market surveillance data and files

Track and report on product-related non-conformances and complaint status

Lead and champion continuous improvement

Analyze key performance indicators and drive quality improvements

Qualification

Quality Management System (QMS)FDA QSR Part 820ISO 13485Certified Quality Engineer (CQE)Risk management toolsDesign VerificationValidationStatistical process controlLean ManufacturingProject managementCommunication skillsOrganizational skills

Required

Bachelor's or Master's degree in Engineering, Science, or a related field (e.g., Mechanical, Biomedical, Quality Engineering), or equivalent experience

Minimum of 5 years of experience in quality engineering, R&D, or manufacturing within the medical device or MedTech industries, or other appropriate technical experience

In-depth knowledge of FDA QSR Part 820, ISO 13485, and EU Medical Device Regulations

Hands-on experience with Design Verification and Validation (V&V) test plan development, test method validation, execution, and report review

Proficiency in risk management tools such as FMEA and root cause analysis

Strong analytical skills and experience with statistical process control and design of experiments, and overall valid statistical analysis

Excellent communication and teamwork skills, with the ability to work effectively in a fast-paced start-up environment

Proven track record of successful project management and leadership in a quality engineering role

Ability to work independently and balance multiple priorities in a fast-paced, FDA regulated environment

Strong verbal and written communication skills

Strong organizational and planning skills, with an attention to detail

Preferred

Certified Quality Engineer (CQE) certification from the American Society for Quality (ASQ)

Experience with Lean Manufacturing tools and techniques

Experience with collecting, analyzing, and presenting quality system performance data for Management Reviews

Familiarity with international regulatory requirements (e.g., MDR, TGA, PMDA)

Experience with electronic Quality Management Systems (eQMS)

Benefits

Comprehensive benefits

Equity

Company

Zenflow, Inc.

Forty million men in the US and over 500 million worldwide suffer from urinary obstruction related to benign prostatic hyperplasia (BPH).

Founded in 2014

South San Francisco, California, USA

11-50 employees

http://zenflow.com

Funding

Current Stage

Growth Stage

Total Funding

$80.07M

Key Investors

Cook MedicalInvus OpportunitiesEight Roads Ventures

2024-11-18Series C· $24M

2021-04-15Series B· $24.37M

2018-02-07Series A· $31.4M

Leadership Team

Shreya Mehta

Chief Executive Officer

Jamey Nielsen

Vice President Research And Development

Recent News

Bizjournals.com Feed (2025-11-12 15:43:17)

'It's a rocket ship from here': Meet the woman-led company with a new way to help men with an old problem

2026-01-22

BioWorld Financial Watch

Proverum, Zenflow secure FDA nod for systems to treat BPH

2025-12-19

GlobeNewswire

FDA Approves the Zenflow Spring® Implant and Delivery System for First-Line Interventional Therapy of Patients with Benign Prostatic Hyperplasia (BPH)

2025-12-12

Company data provided by crunchbase