The Sr. Mechanical Engineer Disposables/Consumable Products will play a key role in the the Product Development team to design, develop & improve the disposables/consumable products utilized for the Tablo System. This person will interact with both internal resources, external design houses, suppliers, & Contract Manufactures (CMs) on efforts to develop new designs, improve product quality, increase manufacturing capacity. The Disposables / Consumables Engineer will work closely with cross functional team members to take ideas from concept to implementation. The individual is also be expected to support prototyping, testing, risk management & documentation activities.
Essential Job Functions
- Leverages experience & knowledge of mechanical engineering, & medical devices to participate in the design & development of Outsets products & intellectual property.
- Develops new concepts from initial design to market release.
- Create & translate design concepts into 3D CAD, with emphasis placed on design for low-cost, high volume manufacturing.
- Works closely with cross functional teams in developing & implementing design solutions. Ability to design with systems perspective.
- Design & work in collaboration with cross-functional teams to develop & build benchtop test fixtures.
- Perform component, module & system level testing on test fixtures, functional test beds (FTBs), prototype machines & Tablo systems & generate test data.
- Analyze data & present/report findings to the engineering organization.
- Generate & maintain relevant design documentation, including risk analyses, FMEAs, engineering drawings, theory of operations & system architecture documents.
- Contribute significantly to verification testing & validation testing, including generating test plans, protocols & reports, & overseeing test execution.
- As a key member of a cross-functional team, ensure smooth transition of new products into manufacturing environment in low-cost global regions.
- Performs troubleshooting of component & system level issues identified in R&D, manufacturing, reliability testing & field, including root cause analysis.
- Perform any other duties assigned related to product development.
- Experience with designing hardware products in an FDA or other regulated industry; comfortable with concepts of design input, design output, traceability, & risk analysis.
- Create design solutions utilizing engineering methods with good documentation processes, releasing design documentation through an ECO process.
- Interfaces with vendors and/or directs or coordinates prototype fabrication & assembly activities to ensure products & systems conform to engineering specifications; documents designs & manufacturing recommendations.
- Define HRS & SYS basing on industry needs.
- Approximately 15% travel required, including international.
- SolidWorks experience preferred. Experience with PDM and/or Agile EC a plus.
- BS. in Mechanical or Biomedical Engineering or equivalent; MS preferred
- Minimum of 5 years of relevant experience doing product design & development of disposable plastic products in the medical device industry
- High level of proficiency on 3D CAD design package, preferably Solidworks, including drafting standards & GD&T
- Extensive experience & understanding of high volume manufacturing techniques such as over-molding, encapsulation molding, RF welding, ultrasonic welding & other techniques
- Basic understanding of data analysis & statistical method
- Knowledge of Medical device design controls & project management skills
- Strong mechanical, analytical, & technical abilities
- Demonstrated knowledge of sound design principles & practices
- Demonstrated knowledge of Risk Management techniques & CAPA process
- Familiar with working within formal design control processes, writing test protocols & reports
- Excellent verbal & written communication with all levels of technical & operating management
- Experience in the Medical Device industry, specifically in high volume consumables. Extra preference given to experience in high volume consumables which physically interface with capital equipment
- Understanding & experience with blood contacting products, including hemodynamics, flow characteristics & material/geometry biocompatibility
- Understanding of elementary chemistry & biochemistry