Ablative Solutions, Inc.
More than 1 billion people have hypertension (high blood pressure). More than half the people treated for hypertension and not able to do not achieve target (control) blood pressure of 130mmHG systolic over 80mmHg diastolic.
Ablative Solutions, Inc. (ASI) has developed propriety technology to treat uncontrolled hypertension
- The Peregrine System™ Kit includes the Peregrine System™ Infusion Catheter (Peregrine Catheter) and Ablative Solutions Inc.’s Dehydrated Alcohol (ETOH).
- The minimally invasive procedure is performed under mild/conscious sedation.
- The Peregrine Catheter is advanced through a small incision in the groin and guided up to the renal arteries using angiography (X-ray with contrast). The system will deliver a small dose of dehydrated alcohol to the region just outside the artery (perivascular space), where the nerves are located, to interrupt the over-signaling of the sympathetic nervous system, that contributes to hypertension; this form of therapy is called alcohol-mediated renal denervation.
The company raised $77 million in capital in January of 2019 to develop the clinical program to obtain the CE Mark and FDA approval for the Peregrine System Kit. The company is currently conducting clinical studies in Europe and the United States to collect data in support of regulatory submissions intended to gain the above approvals and bring this therapy to market.
Position Title: Quality Engineer (Level – Senior to Principal)
Reporting Relationship: Reports to VP, Global Quality Systems
FLSA Status: Exempt
Reporting to the VP of Global Quality Systems, the Quality Engineer is responsible for Design Assurance and Quality Engineering support for ASI medical device products. This role serves as the subject matter expert (SME) for Quality Assurance and Quality Control activities related to design, manufacturing, release and testing of medical device product in compliance with ISO 13485, ISO 14971 and MDD/MDR requirements. Leads the development and implementation of required procedures, documentation, inspections, instructions, protocols/reports in compliance with applicable requirements to ensure ASI products adhere to established specifications and industry quality standards.
- Provide Quality Engineering support in successful transition from clinical to commercial manufacturing using design and manufacturability concepts, including statistical techniques.
- Assist in the development and implementation of validation and inspection methods to analyze and assure product quality based on sound statistics.
- Manage quality engineering activities at contract manufacturing organizations from receiving to final release, including but not limited to, training, validation, and continuous monitoring of product/process performance.
- Manage and conduct root cause investigations and corrective actions for nonconformances for quality issues, product design, and manufacturing & testing processes at contract manufacturing organizations.
- Responsible for working with R&D and Operations including supplier monitoring and audits, risk management and internal controls while ensuring compliance with ISO 13485, 21CFR820 and other applicable standards and regulations pertaining to medical device products.
- Assist business partners to ensure that process development, manufacturing, scale up and project timelines are consistently met per corporate objectives.
- Contribute to the successful execution of departmental and company goals.
- Regularly update and recommend to ASI stakeholders the status of objectives, projects, and goals, particularly how they relate to cross-functional business objectives.
- Assist in technology transfer to partner or contract manufacturing organizations, as applicable.
- Promote and support a quality and continuous improvement culture.
- Other activities as assigned.
- This position may or may not have direct supervisory responsibilities, depending on the needs of the company and as determined by the CEO and reflected on the Organizational Chart.
- Bachelor’s degree in Engineering or related technical specialty.
- Quality engineering related professional certification a plus.
- 10+ years of experience in design/manufacturing quality engineering in the medical device industry (catheter experience preferred).
- Experience in product and process validations in compliance with FDA 21CFR820, MDD, MDR, ISO 13485 & 14971 and other applicable regulatory requirements.
- Experience with root cause investigations and corrective actions for nonconformances.
- Experience in the oversight and management of contract manufacturing organizations.
- Experience with writing/editing/reviewing effective procedures and technical documents.
- Well versed in best practices for Design Assurance, product/process Risk Management and Statistical techniques.
- Understanding and application of risk management and validation methodologies.
- Familiarity with one or more types of Quality System Software’s used in the industry.
- Excellent organization, communication (written and verbal), and interpersonal skills.
- Positive mindset, flexibility, and the ability to build cooperative working relationships with internal and external stakeholders in a startup environment.
- Ability to learn fast and work successfully within a team/collaborative environment, with a high level of professionalism and sense of urgency to produce high quality outputs within given timeframes.
- Critical thinking and problem-solving abilities to propose practical and achievable solutions.
- Detail orientation with the ability to detect and correct errors and/or inconsistencies in documentation.
- Proficient in MiniTab (or equivalent statistical software) and Microsoft Office applications e.g. Outlook, Word, Excel, Visio, PowerPoint, and Teams.
Physical Demands and Conditions Requirements:
- This position may be remote home-office based or company office based, depending on where the incumbent resides.
- It requires up to approximately 20-25% travel which may include, but is not limited to, supplier visits/audits, applicable conference/seminar attendance, regulatory audits/inspections, and internal meetings.
- General office equipment and some engineering specific equipment.
Interested candidates should submit their resume and cover letter to: email@example.com