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Manufacturing Engineer Technical Lead

Location: Eden Prairie, MN

CHF Solutions is an early stage company focused on commercializing the Aquadex FlexFlow® system. Our objective is to improve the quality of life for patients with heart failure and related conditions, such as fluid overload. We are seeking a Manufacturing Engineer Technical Lead for our Eden Prairie, MN location.

Individual in this role will drive critical manufacturing initiatives to completion.  These initiatives may include sustaining of existing production as well as support of new product introductions.  Principal manufacturing engineer will have technical knowledge to support both capital equipment and disposables product lines. Responsibilities include production support, process development (supplier and in-house), CAD support, design of manufacturing & testing equipment, tooling, and fixtures, and design verification & validation activities.

POSITION RESPONSIBILITIES

  • Support and lead manufacturing initiatives to ensure robust product flow
  • Take on leadership responsibilities for the cross-functional team efforts on high visibility production projects
  • Participate on NPI projects as a core team member
  • Lead in-house and supplier process development and validation activities
  • Develop detailed specifications and drawings for mechanical sub-systems and electromechanical test equipment
  • Identify and liaise with suitable component and service providers
  • Ensure that all products comply with relevant standards
  • Understand clinical requirements and ensure that products meet the expectations
  • Design electromechanical manufacturing & testing equipment, tooling, and fixtures
  • Manage, plan and conduct verification & validation activities
  • Optimize manufacturing process and procedures
  • Participate in CAPA and NCMR processes
  • Provide CAD design skills to the product development team

QUALIFICATIONS

  • Minimum 10+ years of experience in medical device development and manufacturing.  Experience with both capital equipment and disposable products would be preferred
  • Bachelor’s degree in Engineering
  • Knowledge of medical device development and manufacturing procedures and regulatory requirements
  • Strong analytical and problem solving skills.
  • Ability to lead complex cross-functional efforts in support of manufacturing.
  • Working knowledge of CAD tools would be advantageous

OTHER SKILLS

  • Strong focus on meeting deliverables
  • Ability to work in a small team and a fast paced “start-up” environment with strong time management skills
  • Strong analytical skills
  • Strong communication skills
  • Knowledge of Design for Manufacturability would be advantageous

How to Apply: If you are interested in applying for this position, email your cover letter and resume to hr@chf-solutions.com. Please indicate the position that you are applying for and the Requisition ID.

Requisition ID: 18-045

CHF Solutions, Inc. is an equal opportunity employer.

The above statements reflect the principal function and most significant duties of the job necessary for its evaluation in relation to other jobs in the organization, and shall not be construed as a detailed description of all the work requirements that may be inherent in the job.

CHF Solutions