Careers at BiVACOR^®

MANUFACTURING QUALITY ENGINEER II – PROCESS VALIDATION

Location: Huntington Beach, CA

OVERVIEW

This position is responsible for ensuring compliance with regulatory requirements (FDA, ISO, GMP) by developing, executing, and maintaining validation protocols. This position focuses on Equipment Qualification (IQ/OQ/PQ), Process Validation, and Test Method Validation to ensure product quality, reliability, and regulatory compliance. The ideal candidate will have strong technical expertise in medical devices, leadership skills, and the ability to drive continuous improvement in validation processes.

KEY RESPONSIBILITIES

Validation Leadership

• Lead and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for manufacturing and laboratory equipment.
• Develop and manage Process Validation (PV) strategies, including PPQ (Process Performance Qualification) and ongoing monitoring.
• Conduct Test Method Validation (TMV) to ensure accuracy, precision, and reproducibility of analytical methods.

Regulatory Compliance

• Ensure compliance with FDA, ISO 13485, GMP, EU MDR, and other regulatory standards.
• Author and review validation documentation (protocols, reports, SOPs) to meet regulatory expectations.
• Support internal/external audits and regulatory inspections (FDA, Notified Bodies).

Risk Management & Continuous Improvement

• Apply risk-based validation approaches to prioritize validation activities.
• Identify and implement process improvements to enhance efficiency and compliance.
• Lead investigations into deviations, non-conformances, and CAPA.

Crossfunctional Collaboration

• Work closely with Manufacturing and Engineering to ensure validation requirements are met.
• Train and mentor junior engineers on validation best practices.

Continuous Improvement

• Support Lean and Six Sigma methodologies to enhance efficiency.
• Drive initiatives to reduce defects, improve yield, and optimize processes.
• Support strategies for cost-effective quality improvements.
• Support quality improvement models, corrective and preventive action, and overcoming barriers to quality improvement.
• Participation in external audits – develop a response to queries during and following the audit.
• Initiate action to prevent the occurrence of non-conformities relating to the product, process, and quality system, and follow through the non-conformance and failure investigation process affecting Quality, and report verbally and in writing to the executive team regarding the progress and results of projects.

Cross-Functional Collaboration

• Work closely with R&D, Regulatory Affairs, and Manufacturing teams.
• Provide technical guidance on quality-related issues.
• Train and mentor junior quality engineers.
• With the assistance of Quality and Regulatory personnel, prepare and maintain documentation suitable for regulatory submissions for IDE human clinical studies.

REQUIRED SKILLS & QUALIFICATIONS

• Education: Bachelor’s degree in Engineering.
• Experience: 4+ years in Quality/Validation Engineering within medical devices, pharmaceuticals, or biotechnology.
• Technical Expertise:
  • Strong knowledge of IQ/OQ/PQ, Process Validation, and TMV.
  • Familiarity with FDA 21 CFR Part 11, Part 820, ISO 13485, and GMP.
  • Experience with statistical tools (Minitab, JMP) and validation software.
• Soft Skills:
• • Excellent problem-solving, project management, and communication skills.
  • Ability to lead cross-functional teams and drive validation projects to completion.

Preferred Qualifications

• ASQ Certified Quality Engineer (CQE) or Certified Software Quality Engineer (CSQE).
• Software Validation experience
• Experience with automated manufacturing systems, LIMS, or ERP systems.
• Knowledge of Six Sigma/Lean Manufacturing methodologies.

SALARY: $91,900 – $99,600 annually, based on experience

To apply, please send a cover letter and resume to careers@bivacor.com

Working at BiVACOR^®

BiVACOR^® is a clinical stage medical device company developing the BiVACOR Total Artificial Heart (TAH), the first long-term therapy for patients with severe heart failure. The TAH is designed to replace the complete function of the native heart and address the global unmet need of patients with end-stage heart failure (HF) by providing a next generation life-extending solution.

Headquartered in Huntington Beach, CA and with an international office in Brisbane, Australia, BiVACOR was founded in 2008 by a team of internationally renowned biomedical engineers and cardiac surgeons, including Chief Technical Officer, Daniel Timms, PhD and Chief Medical Officer, William Cohn, MD. The original IP was developed by Daniel Timms who continues to collaborate with various researchers and institutes in Australia. Our highly driven and performing team has complementary science and business minds to focus on “Replacing Hearts and Restoring Lives.”

Today, BiVACOR has a robust collaborative network that extends nationally and internationally and boasts a team of world-class engineers, medical specialists, and business executives fervent to advance this ground-breaking technology. Core to us and our culture is collaboration, working hard and recognizing those around us.

BiVACOR is an equal opportunity employer. We are committed to creating an inclusive environment for all employees. Our employment decisions are based on individual qualifications, job requirements and business needs without regard to race, color, marital status, sex, sexual orientation, gender identity and/or expression, age, religion, disability, citizenship status, national origin, pregnancy, veteran status and or any other legally protected characteristics. We are committed to providing reasonable accommodation, if you need an accommodation to complete the application process, please email hr@bivacor.com.

Our Benefits and Perks

Health and Welfare

• Medical Benefits – Numerous HMO and PPO options, several of which have monthly premiums fully employer funded.
• Dental/Vision, Short-term & Long-term Disability also available at low employee cost.

Vacation and PTO

BiVACOR also has very generous vacation and PTO policies. Vacation policy for first year employees is 80 hours per year. Increasing yearly up to 136 hours upon 7th year of employment. In addition to vacation, we also have a PTO policy equaling an additional 80 hours of time off per year.

401(k)

BiVACOR proudly offers both Non-Elective and Elective 401(k) plans.

Our Non-Elective 401(k) is a 4% employer only contribution, made on your behalf each pay period and immediately vested upon 90-day qualification.

Our Elective 401(k)-employer match is up to 6%. That means that for every dollar you contribute to your 401 (k), you will receive a matching dollar-for-dollar contribution in your account up to 6% of your pay.

Incentives

Short-Term and Long-Term Incentives are also part of our current benefit package.