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System engineer must be able to understand a full electro-mechanical system and manage the technical issues and solutions of manufacturing these complex systems. Must have a proven track record of working in manufacturing engineering groups of Medical device companies.Systems Engineer, Console OperationsDir. Operations, Console
DepartmentOperations, ConsoleThe System Engineer will be a key contributor on the Technical team, developing a therapeutic medical device. You will be part of the leadership that makes the main design decisions. You will define requirements, develop measurement methods, perform characterizations of performance, establish pass criteria for tests and design concepts that we will implement together with R&D as a team. Under limited supervision, and in accordance with all applicable federal, state, and local laws and regulations and procedures and guidelines, the responsibilities of the position include performing the following activities:Project/Sub-system technical lead: Understand Design requirements, technical specifications and write Manufacturing test and build procedures to assure compliance with system and sub system specifications. Support the hardware and software teams in their design and verify manufacturability. Lead traceability efforts documenting the that design requirements and Specification are covered with manufacturing testing and documentation where appropriate.Lead failure investigations and conduct Root cause analysis, implementing solutions in manufacturing process with Validation and/or Verification as required.Lead the effort to document pFMEA and maintain during the life cycle of product with every change.Perform measurements, create engineering designs, develop plans and keeping laboratory notebooks on all work.function as Operations technical member or, at times, or at time as Operation’s technical leader of cross functional teams.Solve engineering problems from the component through system level.Conduct testing (Bench, V&V, in vivo) developing and utilizing test protocols and generating written reports.Manage sub-projects, identifying the resources required, and working with Bolt’s leadership to plan milestones in the development and get the right set of features implemented for each one, in order to eliminate project risks early, and maximize the value to the patients, physicians and other stake holders. Write and define software and hardware interface specifications and requirements.Develop test methods and test setups, and formally validating those.Plan, conduct and document tests in written reports (Integration, Verification and Validation).Write system and software documentation Build simulations and models of system functions, and lead feasibility studies.Act as liaison between external vendors and core team.other duties assigned as neededEducation:A Bachelor’s Degree in Engineering or equivalent is required. A Master’s Degree is preferred.Required Experience:Must have three (3) plus years’ experience in engineering practice including technology or product development responsibility along with one (1) year of providing technical leadership on cross-functional teams.Must have experience in development processes and in documentation writingMust be familiar with design control, engineering change orders (ECO), Corrective Actions and Preventive Actions (CAPA) and software version control.Experience in the medical device or the aero-space industries is a plus.Knowledge of medical device electrical standards such as the IEC 60601 is preferred.Knowledge and experience with Matlab, Mathematica, LabView or Minitab software is a plus.Hands on experience in use of electrical signal measurement devices is requiredWorking knowledge of communication protocols such as Ethernet, RS232, SPI, I2C, CAN bus is an advantageExperience in development processes and in documentation writing is an advantageWorking knowledge of requirement management systems, such as DOORS, Requisite Pro, JIRA, JAMA is an advantageExperience with Agile Software development methods is preferredExperience with implementing algorithms developed with numerical simulation and scripting languages including MATLAB and/or Python, is an advantage.Knowledge, Skills, and Abilities: Motivated natural leaderMust have excellent communication skills and the ability to express complicated technological ideas in layman terms. Must have strong analytical reasoning.Must have problem solving capabilities. Self-driven individual who is capable and excited to learn about new technologies.
- ID: #49220051
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State: California
Carlsbad
92008
Carlsbad
USA
- City: Carlsbad
- Salary: $120,000 - $140,000
- Job type: Permanent
- Showed: 2023-02-15
- Deadline: 2023-04-08
- Category: Et cetera