DivIHN (pronounced “divine”) is a CMMI ML3-certified Technology and Talent solutions firm. Driven by a unique Purpose, Culture, and Value Delivery Model, we enable meaningful connections between talented professionals and forward-thinking organizations. Since our formation in 2002, organizations across commercial and public sectors have been trusting us to help build their teams with exceptional temporary and permanent talent.

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For further inquiries regarding the following opportunity, please contact our Talent Specialist Meghna at (224) 369-4230

Title: Sr. Engineer Disposables RandD, Sustaining (Hybrid) Location: Plymouth, MN Duration: 12 Months

Workers can be remote/hybrid but must be local and able to come into the office at least three days a week

Description: Essential Duties and Responsibilities: Create new 3rd party supplier documentation including design specifications, labeling, design drawings, etc. for peritoneal dialysis disposable sets. Create, modify, and maintain design history files. Perform change control assessments. Work closely with project manager and technical lead to achieve project commitments. Adhere to design control procedures, general safety rules, company policies and procedures, FDA and international regulations and guidance.

Qualifications: Experience working with external manufacturing partners and supplier relations. Experience creating and modifying medical device design outputs including receiving and inspection criteria. Experience in medical device product support and change control management. Experience in design transfer from RandD to manufacturing. Working knowledge of FDA Design Controls and ISO 13485 Quality Management Systems. Working knowledge of ANSI/AAMI/ISO 14971 Medical Devices - Application of Risk Management to Medical Devices. Takes initiative with a high aptitude for learning, innovation, and implementing best practices and continuous improvements. Strong collaboration, verbal and written communication skills. Strong attention to detail, organized, and able to independently manage multiple priorities. Ability to read, write and comprehend English.

Experience and/or Background BS in Mechanical, Plastics, Biomedical Engineering or a related field, MS preferred. 3 - 5 years of related experience in Class II or Class III disposables medical product development. Design for Six Sigma (DFSS) training or certification preferred.

About us: DivIHN , the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.

DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.