Product Engineer II
This position is primarily a product engineering role, with focus on design, prototyping, development, scale-up, and transfer of new customer-owned products and support of existing products. This position serves as the primary project lead for new products and will be responsible for, or participate in, the selection (or design) and qualification of purchased components, definition and maintenance of product Bills of Materials, the execution of any needed product testing, design of prototype tools and fixtures, the appropriate documentation of all work from initial prototyping to operations transfer, and any other activities required to produce a new product and help a customer bring it to market.
ESSENTIAL JOB DUTIES & RESPONSIBILITIES
- Provide project management, technical leadership and innovation for new product development in a small company environment. Proactively work across the organization to bring new customer projects to market.
- Effectively prioritize and manage multiple concurrent design engineering projects as assigned.
- Document design activities clearly in accordance with Avalon Product Delivery Process (PDP) for new product development. Lead gate reviews and ensure checklists are completed and PDP requirements are met.in a manner that meets customer needs. Communicate articulately and with technical authority to both internal and external audiences.
- Accurately and thoroughly complete detailed product designs that meet customer requirements. Define the product structure; identify appropriate subassemblies and components, and Bill of Materials for new and existing products. Oversee the creation and maintenance of product Bill of Materials within the company resource planning system.
- Plan, execute and document any required product testing including functional testing, theoretical flow analysis (CFD), Design Verification and Validation testing, sterility validations, packaging ship testing and pouch sealing validations, and any needed component qualifications in accordance with customer requests and with Avalon and customer quality requirements.
- Generate, manage and modify all necessary drawings and 3d models. Drive improved alignment of dimensions and tolerances with manufacturing and inspection capabilities while still maintaining design intent. Help to define and implement Avalon engineering design standards and drafting protocols, and standardized drawing, detailing and tolerancing practices.
- Work with suppliers to develop and qualify new components, tooling and processes. Thoroughly understand supplier and process dimensional capabilities. Work with Supply Chain to select and develop suppliers throughout the new product development process.
- Lead prototype builds to prove feasibility
- Partner effectively with Manufacturing and Quality to drive new products from initial concept through to a successful hand-off to Operations. Design for manufacturability and work closely with Manufacturing to ensure that design intent and product function can be achieved robustly and repeatedly.
- Support Operations as needed in evaluating and executing Engineering Change Reviews and in product transfer and validation projects.
- Assist in business work flow and efficiency improvement projects.
- Follow all Quality procedures and employment policies ensuring that FDA and Quality standards are achieved in an ethical manner.
- All other duties as assigned
EDUCATION & EXPERIENCE REQUIREMENTS
- Bachelor’s degree in engineering or related technical field.
- Minimum of 3 years design engineering experience required in a highly regulated business, medical device manufacturing preferred. Possibility to hire at Sr. level (min. 5 yrs.)
- Experience in advanced engineering & statistical problem solving methods. Six Sigma Green Belt or Black Belt certification is highly valued.
- Understanding of common machine shop practices, fixture design and assembly techniques.
- Related experience within international standards (ISO 13485 / 9001), FDA and European quality systems requirements (QSR, MDD), and risk management (ISO 14971, DFMEA and PFMEA).
SKILLS & ABILITIES
- Strong medical device design engineering and manufacturing experience
- Excellent project management capabilities, establishing timelines, predicting risks and developing mitigation plans.
- Robust critical thinking skills with the capability to quickly dissect situations and solve problems.
- Proficient in statistical analyses including graphical representation of data, hypothesis testing, and the formulation, execution, and analysis of Designs of Experiments (DOE).
- Excellent verbal and written communication skills. Capable of explaining complex topics to others.
- Strong skills in planning and executing engineering studies, verification & validation protocols, final reports, etc.
- Training and practical experience in applying Design for Six Sigma is preferred.
- Must exhibit good interpersonal skills, and the ability to manage his/her own priorities and workload while working in a team environment
- Willing and able to travel to Mexico as required
- Spanish as second language highly valued
- Proficient in navigation and use of the Windows operating system in a networked environment.
- Strong understanding and ability to use Microsoft Office Tools (Outlook, Word, Excel, Project, Visio, PowerPoint, and SharePoint).
- Functional knowledge of Minitab
- Knowledge of 2D and 3D CAD software including Autodesk AutoCAD, Inventor, and Mechanical Desktop
WORKING CONDITIONS & PHYSICAL DEMANDS
Office & Manufacturing environment. 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.
Nordson Corporation provides equal employment opportunity to all applicants and employees. No person is to be discriminated against in any aspect of the employment relationship due to race, religion, color, sex, age, national origin, ancestry, disability, sexual orientation, gender identity, genetic information, citizenship status, marital status, pregnancy, veteran status or any other status protected by applicable federal, state, or local law.
All employment offers are contingent upon successful completion of our pre-employment drug screening and background/criminal check, consistent with applicable laws.
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