Advanced Manufacturing Engineer - Mechanical

HistoSonics is a commercial-stage medtech company advancing the Edison® System, a novel non-invasive sonic beam therapy based on histotripsy. Since receiving FDA De Novo grant for the non-invasive destruction of liver tumors in 2023, the company has progressed beyond initial market entry into commercial expansion, reimbursement momentum, and ongoing clinical and pipeline development. In addition to its current liver tumor indication, HistoSonics is pursuing future indications across multiple applications including kidney, pancreas, prostate, neuro, women’s health, and other significant underserved human health areas, to realize the broader potential histotripsy across multiple disease states and medical specialties.

We offer an exciting work culture where cutting-edge science meets real-world application, and each team member’s contribution is important to our success in ensuring our physicians and their patients get what they need most.

Location : Madison, WI, or Plymouth, MN - (75% on site)

Travel: Approximately 25%

Position Summary

The Advanced Manufacturing Engineer is responsible for developing and improving current supply chain processes and supporting supply chain activities for new product introductions. This role is an individual contributor position, focused on driving operational excellence through process optimization, technical innovation, and cross-functional collaboration. The engineer will play a key role in supporting advanced manufacturing techniques to enhance efficiency, quality, and scalability within the organization.

• Supports efforts to analyze and improve existing manufacturing and supply chain processes, identifying opportunities for increased efficiency and cost reduction. Including research and development of production fixtures and automation
• Support new product introductions by collaborating with cross-functional teams to ensure seamless supply chain integration and readiness.
• Utilize data-driven methodologies to solve complex problems and recommend actionable improvements for manufacturing operations.
• Work closely with sourcing, quality, and production teams to develop and implement best practices and advanced manufacturing technologies.
• Ability to work cross functionally to support design and manufacturing needs and ensure
• Support the implementation of new equipment and manufacturing fixtures.
• Ensure compliance with company standards and regulatory requirements throughout all supply chain activities.
• Communicate effectively with internal stakeholders and external partners to facilitate project success and continuous improvement initiatives.
  
  

Qualifications

• Possesses a bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or a related field
• Minimum of 3 years of experience in a manufacturing engineering role, preferably within mechanical systems or components. Experience working with suppliers or manufacturing automation a plus
• Demonstrated expertise in manufacturing processes, mechanical engineering principles, and continuous improvement initiatives.
• Proficiency in CAD software for design, modeling, and documentation of mechanical parts and assemblies. Understanding of GD&T is a plus
• Strong analytical and problem-solving skills, with a data-driven approach to decision-making.
• Experience with design for manufacturing of mechanical components , ERP systems, and data analytics tools.
• Experience in medical device manufacturing and familiarity with IQ/OQ/PQ activities.
• Excellent communication and interpersonal skills, with the ability to collaborate across departments and with external partners.
• Ability to work independently and manage multiple priorities in a fast-paced environment
  
  

Benefits : We offer a comprehensive benefits package for full-time employees. This includes health, dental, and vision insurance, life, short-term and long-term disability insurance, 401(k), paid time off, and more.

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.