Description

Nuwellis, Inc. is a medical device company dedicated to transforming the lives of patients suffering from fluid overload with its Aquadex SmartFlow ultrafiltration therapy.

The Development Engineer II has the responsibility to execute development and sustainment activities of various complexities for medical devices utilized in Aquapheresis therapy. These devices include electro-mechanical systems and related disposable mechanical products and accessories. Individual in this role will be involved with developing new products, enhancing existing products, and implementing compliance improvements. This position partners with Marketing, Quality, Regulatory, Clinical and Operations and is critical to the success of Nuwellis' business strategy.

This is an onsite position, requiring a full-time in-person presence at Nuwellis' corporate office in Eden Prairie, MN.

Essential Duties And Responsibilities

• Technical expert on cross-functional development projects.
• Execute tasks of various complexities as assigned by the project manager throughout all development phases and in accordance with all applicable procedures, regulations, and standards.
• Contribute to completion of project milestones
• Works under general supervision of engineering manager
• Evaluate product qualification activities and risk management documentation against released standards and best practices. Close gaps as appropriate.
• Generate new product development concepts and prototypes for existing product enhancements as well as new product designs.
• Develop and execute product verification and validation activities.
• Review, initiate, and/or approve change requests associated with: design verification & validation, risk management, usability, biocompatibility, shelf life, test method validations, equipment qualifications, sterilization, packaging, and labeling.
• Partner with other functional areas in preparing test plans, data analysis, specifications, risk analysis, and change implementation.
• Capacity to interpret and contribute to electro-mechanical systems and related disposables.
• Participate in, and occasionally lead challenging team discussions resulting in robust decisions with respect to product development plans.
• Facilitate effective communications with project team, support team and management.
• Manage project execution to achieve project plan/contract. Proactively address issues to minimize their impact to project.
• Participate in project updates with management in a professional and unbiased manner.
• Occasionally take on responsibility to manage development projects involving other cross-functional members.
• Effectively engage with external suppliers as required by the project.
  
  

Requirements

MINIMUM QUALIFICATIONS

• Bachelor's degree in related field such as Mechanical, Electrical, Biomedical Engineering.
• 2 years of experience in medical device development and quality systems.
  
  

Preferred Qualifications & Competencies

• Experience in biocompatibility, human factors, electrical safety, hardware, and sterilization industry standards.
• Excellent writing and verbal communication skills.
• Ability to influence others.
• Strong analytical and problem-solving skills.
• Demonstrated decision making skills.
• Good interpersonal skills.
• Ability to handle multiple tasks/projects and manage priorities accordingly.
• Ability to manage through ambiguity.
• Ability to meet vendor credentialing requirements.