Verification & validation Engineer II - BIOCOMPATABILITY
The Verification & Validation Engineer (V&V) II will play a pivotal role in leading and enhancing the organization's process validation related to the development and manufacturing of Class III Active Implantable Medical Devices (AIMD) with a focus on Biocompatibility. This position involves managing complex verification and validation plans for medical device design functions across mechanical and biomedical disciplines. The V&V Engineer II will not only develop and conduct advanced verification and validation activities but also supervise inspection and assembly processes. Working closely with internal teams from mechanical, software, and electrical engineering backgrounds, this role supports development initiatives and acts as a critical liaison between the company and external vendors/suppliers to ensure all manufacturing and testing activities robustly support product development and its transition to production.
BiVACOR is looking for highly motivated and adaptable team members who are eager to drive forward this active and dynamic project. The position demands strong organizational, time management, and technical skills, along with analytical and problem-solving capabilities in a deadline-driven environment. Offering the chance to work with minimal supervision, this role is ideal for those seeking significant career advancement in a company committed to moving its groundbreaking products from the laboratory to the clinic.
Responsibilities
- Lead the development and execution of biocompatibility verification and validation protocols in alignment with system requirements and compliance with regulatory standards including ISO, IEC, and FDA guidelines.
Supervise and conduct detailed inspection, assembly, and biocompatibility V&V testing to ensure adherence to product specifications.
Design and fabricate test fixtures; maintain and calibrate these fixtures to ensure ongoing reliability and accuracy.
- Create, analyze, and summarize documentation related to biocompatibility verification and validation protocol results for FDA approvals and quality system guidelines.
Develop design input specifications and test designs that align with project goals and biocompatibility requirements.
Engage in design reviews and provide comprehensive biocompatibility verification support to development teams, including system testing, test automation, and procedure development.
Author and critically review Standard Operating Procedures (SOPs) and Work Instructions (WIs) to ensure consistency and compliance across project phases.
- Collaborate with quality assurance teams, both internal and external, to support regulatory submissions and update risk management frameworks.
Assist in managing documentation processes suitable for regulatory submissions.
Lead risk management activities, including the update of Fault Tree Analysis (FTA), design, and process Failure Mode and Effects Analysis (FMEA).
- Manage relationships with external suppliers and vendors to maintain supply chain integrity and project timelines.
Execute and uphold quality agreements and control plans in partnership with suppliers.
Actively participate in supplier visits to ensure compliance and quality standards.
Define and implement processes and technical solutions that support current product designs, enhance manufacturing reliability, and improve overall product quality.
- Manage and lead biocompatibility verification and validation projects, acting as the team leader to coordinate efforts across different functional groups within the organization.
Serve as the primary point of contact for project timelines, deliverables, and resource allocation, ensuring projects are completed on time and within budget.
Facilitate cross-functional collaboration with other departments such as product management, technology, regulatory affairs, and clinical teams to ensure project alignment with organizational goals and regulatory compliance.
Mentor and guide team members, fostering a collaborative environment and enhancing team skills through continuous learning and development initiatives.
Requirements
Bachelor's degree or higher in Engineering (Biomedical or Mechanical), with at least 3-5 years of work experience in Class III medical device development, reflecting a deeper exposure and greater expertise.
Advanced experience in AIMD design or validation is strongly preferred, demonstrating a proven track record in high-stakes environments.
Extensive experience in the Medical Device Industry, including a thorough understanding of engineering design, test, and safety standards (IEC 60601-1, FDA Requirements, ISO 10993, ISO 14708, ISO 11135, and other applicable standards), ensuring compliance and innovative problem-solving.
Expertise in design controls under 21 CFR 820.30, encompassing a comprehensive grasp of design (customer and product) requirements, performance specifications, and verification and validation testing, is essential for this leadership role.
Exceptional technical writing skills for creating clear, concise, and effective design verification/validation documentation and reports.
Significant previous experience in a Design Assurance role, ideally covering all product development phases from conception through commercialization, highlighting a capacity for strategic oversight and detailed execution.
BiVACOR offers a competitive compensation package to include 401k with above-average employer contributions, generous amount of time off, a choice of rich healthcare plans and an array of other benefits.
About the Company
BiVACOR is a clinical-stage medical device company pioneering the development of a long-term therapy for patients with biventricular heart failure. Under the expert direction of its founder and TAH inventor, Daniel Timms, PhD, and the guidance of two luminaries in cardiovascular surgery, William E. Cohn, MD, and O.H. (Bud) Frazier, MD, the BiVACOR TAH is currently undergoing an FDA-approved first-in-human Early Feasibility Study (EFS). Headquartered in Huntington Beach, California, with clinical offices in Houston, Texas, and international offices in Gold Coast, Australia, BiVACOR is committed to addressing the global unmet need of patients with end-stage heart failure awaiting transplant by providing the next generation of life-extending solutions. 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. To learn more about us go to www.bivacor.com.
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.
BiVACOR does not accept profiles or resumes from recruiting firms without a binding written agreement. Any unsolicited submission of services and or resumes in no way creates an obligation or duty by BiVACOR, implied or otherwise.