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: Manufacturing Engineer / Senior Manufacturing Engineer

Department: R&D & Operations

Reporting Relationship: Product Development Management

FLSA Status: Exempt

Location: Ireland


Position Summary

The Manufacturing Engineer is responsible for leading Manufacturing Engineering activities within ASI including activities at contract manufacturing suppliers and distribution centers. They will ensure successful completion of projects and coordination of activities to meet company goals; ensuring compliance to applicable standards and regulations; ensuring world-class manufacturing performance; operating cost-effectively; and identifying areas & driving deliver of projects to achieve continuous improvement. Individual shall collaborate with ASI stakeholders and suppliers to plan for and execute project activity to meet production performance requirements.

Primary Responsibilities

  • Directly manage Manufacturing & Project activity at contract manufacturing organizations, including product builds, product quality issue resolution, process development, technical
  • training, validation, and continuous monitoring of manufacturing performance
  • Technical leadership of the manufacturing transfer of new products and changes to existing products, supporting the successful transition to manufacturing using design for manufacturability concepts, as applicable.
  • Develop and Implement manufacturing capabilities using LEAN principles and tools including but not limited to Value Stream Mapping, Poka-Yoke, Standard Work, Bottleneck Analysis and Line Balance
  • Responsible for working with Quality including management of NCMR’s and CAPA’s, supplier monitoring and audits, risk management and internal controls while ensuring compliance with ISO 13485 and other relevant standards and regulations pertaining to medical device and pharmaceutical products.
  • 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.
  • Support business partners by providing technical leadership for company’s long-term manufacturing and distribution channels.
  • Development and execution of commercial manufacturing timelines consistent with project and regulatory needs;
  • Financial modeling for COGS and scaling up production capacity.
  • Technology transfer to partner or contract manufacturing organizations, as applicable
  • Promote and support a continuous improvement culture and drives cost saving initiatives.
  • Create and manage annual budget for Manufacturing project activities.
  • Provide strong integrity, vision, knowledge, and overall aptitude to the organization.

Supervisory Responsibilities

  • 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.

Education Requirements

  • Bachelor’s degree in Engineering or related specialty.

Experience / Knowledge / Skill Requirements


  • A minimum of 7 years’ experience with at least 3 years in a technical leadership role in a biotechnology, pharmaceutical or medical device industry experience required.
  • Experienced in working within ISO 13485/FDA regulated quality systems.
  • A proven track record in manufacturing and process development in a regulated environment. Medical device catheter product experience a plus.
  • Ability to achieve results in a virtual organization. Experience working with cross-functional teams, project facilitation and demonstrated ability to complete projects on time Knowledge
  • Well versed in both Manufacturing and Product Development Processes, including Risk Management and KPI’s


  • This role is primarily technical in nature; thus, they seek someone who is passionate about Engineering concepts and principles - someone who gets a thrill from how and why things work
  • A seasoned professional in manufacturing & engineering development with knowledge and skills in some or all of the following: DFM, technology evaluation, driving innovative solutions to complex problems, process design and development, materials (polymers and metals), design for six sigma principles, CAD (SolidWorks preferred), statistical techniques, process validation and control.
  • Understanding and application of risk management methodology
  • Excellent analytical and decision-making skills
  • Possess a flexible, pro-active approach to problem solving, be an adept negotiator and apply risk[1]based decisions
  • Ability to develop and maintain strong collaborative relationships with all functional departments of the organization
  • Strong organizational, communication, interpersonal, managerial and leadership skills
  • Ability to effectively and efficiently manage consultants, suppliers, vendors and budgets.
  • Ability to work in a fast paced, high growth environment. Ability to handle multiple tasks with high quality and timeliness standards.

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 approximately 40% travel, which may include trips to visit vendors and suppliers, attend applicable scientific congresses or R&D/Manufacturing trade shows, and internal meetings.

Equipment Used

  • General office equipment.
  • Engineering specific equipment.

Interested candidates should submit their resume and cover letter to: hr@ablativesolutions.com