Product Innovation Engineer II

Value Plastics • Eagan, MN

161d

About The Position

Nordson Medical, a global leader in Interventional Solutions, Fluid Components, and Surgical Solutions, is seeking an experienced and highly motivated individual to join our team. We are committed to creating a diverse and inclusive workplace, and we are looking for candidates who share that same commitment. As a member of our team, you will have the opportunity to work in a dynamic and collaborative environment, where your ideas and contributions will be valued and respected. The Product Innovation Engineer II will be responsible for the design and development of medical devices for the delivery of biomaterials from concept to market. The desired individual will possess medical device design and development skills and experience. This position will work closely with members of the project core team (marketing, manufacturing, quality, and regulatory) as well as interface directly with customers & suppliers.

Requirements

• BS degree in Mechanical or BioMedical Engineering.
• 2-4 years of related experience.
• Experience developing and supporting low to medium volume products in a fast paced regulated environment to meet rigid quality requirements.
• Experience in the medical device industry, specifically with class II devices including research and development and manufacturing operations.
• Ability to understand and work with medical device quality processes and statistics.
• Experience with and training on SolidWorks, SolidWorks Simulation and Enterprise PDM.
• Ability to work in a team environment.
• Excellent interpersonal, communication and strong attention to detail.

Nice To Haves

• Understanding of design controls relating to medical device regulations and the principles of the EU Medical Device Directive (93/42/EEC) and Medical Device Regulation (2017/745), the FDA GMP, ISO-13485, Health Canada and their fundamental requirements.
• Experience developing terminally sterilized medical devices, with an understanding of biological evaluation and medical device sterilization.
• Experience designing injection molded parts.
• Technical project leadership experience.
• Competent in application of statistical analysis software.

Responsibilities

• Manage New Product Development projects from concept through production.
• Prepare the project plan, schedule and budgets.
• Execute the project by coordinating activities, documenting project goals and progress and recommending appropriate changes when needed.
• Demonstrates understanding of the medical device product development process.
• Participate in modeling and encouraging creativity, innovation, data driven decision making, and careful use of scientific methods.
• Compile and analyze operational, test, and research data to establish technical specifications for designing or modifying products, processes, and materials.
• Consistently generate innovative and unique solutions to meet market needs.
• Successfully complete engineering work in one or more of the following: technology development, product design and development, test of materials or products, preparation of specifications, process study and design verification/validation protocol/report preparation.
• Translate customer needs into product requirements and design specifications.
• Responsible for engineering documentation.
• Participate and lead design reviews and provide guidance to improve designs to meet usability requirements while considering design for manufacturing aspects.
• Design and coordinate engineering tests and experiments using techniques such as Design of Experiment (DOE).
• Summarize, analyze, and draw conclusions from complex test results using valid statistical techniques.
• Build Quality into all aspects of work by maintaining compliance to all quality requirements.
• Participate in the Risk Management process including Design, Process and Use Risk Assessments.
• Prepare design/engineering documentation in support of Regulatory submissions.
• Design for plastic injection molding and over-molding.
• All other duties as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Bachelor's degree