Job ID 19000LQA
Available Openings 1
Position Specific Information NxStage Medical, a Fresenius Company is on a mission to transform renal care. To do that, we continually seek the best-of-the-best to expand and improve our team of dedicated, innovative professionals. If you share our mission and are committed to improving the lives of renal patients, then we invite you to explore our career opportunities.
PURPOSE AND SCOPE:
The incumbent will support product or process development activities related to the development, design or manufacturing of NxStage Medical's equipment products.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
Apply state of the art methods to the creation of new and existing circuit card design 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
Lead Risk Management activities to ensure design and process shortcomings are identified and appropriately addressed
Lead the product development team in the adoption and use of best practices and design methodologies
Debugging new designs and developing 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
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.
BS in Electrical Engineering, MSEE Strongly Preferred
EXPERIENCE AND REQUIRED SKILLS:
· 10+ years experience in electrical product engineering and development
· Experience with CPLD's
· Analog experience
· Proven knowledge of Agile development methods
· Power System Design
· Designing for EM/RFI Regulatory compliance for medical devices experience
· Able to run major circuit card development projects from concept to manufacturing
· Reliability design experience
· Proven advanced technical knowledge in product development methodologies, design and implementation
· - Proven knowledge of entire development process, including specification, documentation and quality assurance.
· - Has functioned in a product sustaining role to support electrical component obsolescence and, driving and managing replacement strategy through assessment, design, test and release.
· - Project engineering and management with the ability to assess small and large-scale tasks, identify resource needs, deliverables and generate accurate timelines/schedules.
· - Direct knowledge of 60601-1-2 EMC 4th Edition and proven ability bringing medical products through the requisite test plan generation and execution process and to test agency approval.
· - Interaction with internal Supply Chain and, manufacturer sales representatives, component distributors and, contract manufacturers.
· - Exemplary communication, organization and documentation skills.
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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