PURPOSE AND SCOPE:
Take a key role in developing and improving NxStage’s sterile, single use disposables products. The Sr Disposables Engineer is involved in all parts of a product’s life, from feasibility evaluation for new features and products to improving the quality, performance, and cost of dialysis therapies. Close collaboration with manufacturing, quality, regulatory, and product management counterparts is key to quickly responding to issues, completing projects, and launching new products
The Sr. Disposables Engineer possesses specific product lines knowledge to be a resource and key technical expert to support related projects. The Sr. Engineer is largely unsupervised and self-motivated to lead projects. Shall be capable of being given high level tasks and working independently to organize work, from required Product Engineering Teams (PET) and to produce the final product or outcome assigned.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
- Design new or modify existing products/components to meet patient needs.
- Debug and refine designs and develop reliability improvements to existing & new products.
- Act independently with minimal supervision to conduct smaller approved projects. Expected to make suggestion on improvements based on recent technical knowledge.
- Is familiar with and follows FDA/ISO Design Control principles and regulations in product development.
- Applies Risk based procedures throughout the product development process and the product life cycle.
- Plan and execute design verification and design validations based on existing or modified specifications and standards.
- Authors testing plans, engineering test reports, and position and/or white papers using good documentation practices
- Apply state of the art methods to the creation and modification of NxStage products.
- Contribute to the planning and execution of components of the development process, which apply to product revision or enhancement or a defined piece of a larger project.
- Lead / participate in Risk Management activities including, Fault Tree Analysis, Usability Evaluation, and Failure Mode and Effects Analysis activities to ensure process shortcomings are identified and appropriately addressed.
- Manage routine small projects without assistance.
- Executes projects with clear objectives and timely deliverables. Understand the goals and contents of development and research projects.
- Investigate the feasibility of new projects, systems or approaches
- Use problem solving and corrective action projects using techniques such as DMAIC or 8-D and appropriate statistical tools to resolve design problems and address quality improvement opportunities.
- Respond rapidly and flexibly to emerging issues in production, quality, engineering, or supply chain.
- Facilitate collaboration between multiple manufacturing sites and business units.
- Recommend design improvements.
- Support plant cost reduction projects.
- Provide mentoring and assistance to Engineer II and I level staff.
- Travel (domestic and international) up to 10% is required
- Other duties as assigned.
Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions.
PHYSICAL DEMANDS AND WORKING CONDITIONS:
- The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Bachelor's Degree in related engineering or scientific discipline required; Advanced Degree desirable
EXPERIENCE AND REQUIRED SKILLS:
- 5 - 8 years' related experience;
- Master's degree with >3 years' related experience;
- PhD without experience; or equivalent directly related work experience.
EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity
Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.
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