Location:
Lawrence, MA
Support Research and Development activities related to New Product Development.
Introduction:
NxStage is an Equal Opportunity Employer
The following represents some of the main responsibilities of the above position. This list is not in any order of importance and should not be considered an exhaustive list of possible duties of the position. NxSTAGE Medical, Inc. maintains the right to modify this list at any time.
The incumbent will support product or process development activities related to the concept development, design, and/or manufacturing of NxStage Medical’s equipment products.
Specific Duties:
- Apply state of the art methods to the creation of new and existing mechanical designs for NxStage products
- Lead major projects (or phases of projects) to resolve advanced and complex technical problems
- Perform Risk Analysis including, Fault Tree Analysis (FTA), Operator Misuse Analysis (OMA), and Failure Mode and Effects Analysis (FMEA) activities to ensure process shortcomings are identified and appropriately addressed
- Support Risk Management activities to ensure design and process shortcomings are identified and appropriately addressed
- Debug new designs and develop reliability improvements to existing & new design
- Provide technical support for product engineering, design development, integration, test, and evaluation
- Investigate the feasibility of new projects, systems, or approaches
- Work with Quality Assurance and Research and Development to maintain an approved internal Quality System that meets the requirements of GMP’s, QSR, and ISO 9001
- Support complex automated and semi-automated assembly and test equipment
- Work collaboratively with electrical, disposables, and systems engineering
Education & Qualification:
- BS in Mechanical Engineering; MSME Strongly Preferred
Requirements:
- 5+ years experience in product design
- Proficient in SolidWorks 3D modeling, analysis tools, design detailing, and documentation
- Strong understanding of product and process development for medical devices is preferred
- Understanding of system design, electronics, mechanical, and software integration preferred
- Knowledge of design of experiments preferred
- Technical understanding of product development methodologies, design, and implementation
