<p>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.</p> <p>Summary of the role</p> <p>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.</p> <p>Job Summary</p> <p>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. Applies knowledge and expertise acquired through progressive experience to resolve crucial design issues and/or unique conditions. Keeps informed of new methods and developments affecting their products. 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. He/She independently, or as a member of a team, develops, directs, and executes plans for complex projects.</p> <p>Essential Job Duties and Responsibilities</p> <ul> <li>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. </li><li>Demonstrates understanding of the medical device product development process. </li><li>Participate in modeling and encouraging creativity, innovation, data driven decision making, and careful use of scientific methods. </li><li>Compile and analyze operational, test, and research data to establish technical specifications for designing or modifying products, processes, and materials. </li><li>Consistently generate innovative and unique solutions to meet market needs. Work is expected to result in the development of new or refined products, processes or equipment. </li><li>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. </li><li>Translate customer needs into product requirements and design specifications. Responsible for engineering documentation. </li><li>Participate and lead design reviews and provide guidance to improve designs to meet usability requirements while considering design for manufacaturing aspects. </li><li>Design and coordinate engineering tests and experiments using techniques such as Design of Experiment (DOE). </li><li>Summarize, analyze, and draws conclusions from complex test results using valid statistical techniques. </li><li>Build Quality into all aspects of work by maintaining compliance to all quality requirements. </li><li>Participate in the Risk Management process including Design, Process and Use Risk Assessments.. </li><li>Prepare design /engineering documentation in support of Regulatory submissions. </li><li>Design for plastic injection molding and over-molding. </li><li>All other duties as assigned. </li></ul> <p>Education and Experience Requirements</p> <p>Detail-oriented, energetic self-starter with strong communication and organizational skills. The successful candidate will have a proven ability to multi-task and work collaboratively as well as independently in a dynamic and entrepreneurial environment. Additional qualifications are as follows:</p> <ul> <li>BS degree in Mechanical or BioMedical Engineering. </li><li>2-4 years of related experience. </li><li>Experience developing and supporting low to medium volume products in a fast paced regulated environment to meet rigid quality requirements. </li><li>Experience in the medical device industry, specifically with class II devices including research and development and manufacturing operations. </li><li>Ability to understand and work with medical device quality processes and statistics. </li><li>Experience with and training on SolidWorks, SolidWorks Simulation and Enterprise PDM. </li><li>Ability to be able to work in a team environment. </li><li>Excellent interpersonal, communication and strong attention to detail. </li></ul> <p>Preferred Skills and Abilities</p> <ul> <li>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. </li><li>Experience developing terminally sterilized medical devices, with an understanding of biological evaluation and medical device sterilization. </li><li>Experience designing injection molded parts. </li><li>Technical project leadership experience. </li><li>Competent in application of statistical analysis software. </li></ul> <p>Working Conditions and Physical Demands</p> <p>Office/Lab environment. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.</p> <p>#LI-NS1</p> <p>Interested?</p> <p>If you are interested in being a part of a team and creating an inclusive and diverse workplace, please apply online with your CV.</p> <p>About Nordson Medical</p> <p>At Nordson MEDICAL, you don't have to be a doctor to help save lives. We are the global expert in the design, development, and manufacturing of complex medical devices and component technologies. By joining our team today, you will help us bring innovative ideas to life. Nordson MEDICAL is a global team that works to create components for life-saving medical devices. We offer a supportive culture in a growing and dynamic work environment. Whether you're just beginning your career or you're a seasoned professional, there's a place for you to belong at Nordson MEDICAL. We offer hourly and salary positions in production, maintenance, customer service, quality, engineering, and more. We actively invest in our teams to help you build your skillsets and advance your career.</p>