Mechanical Engineer III #JN -032021-60639

Carlsbad, California
Industry: Mechanical / Manufacture / Electrical Engineers
Job Number: JN -032021-60639

 Description:

  • Be a part of Gas Sensing Technology group as a Senior Mechanical Engineer focused on gas sensing, capnography & related accessory products. As the senior mechanical designer, you will be responsible for the mechanical design of various gas sensing products; next generation and on-market
  • Candidate will utilize the following knowledge and expertise to create market-leading products: optical sensing techniques, absorption spectroscopy, high-precision miniature optics, understanding of gas sensing devices, host system implementations, medical device design and development, and regulatory landscape
  • The position within the Gas Sensing Technology R&D group collaborates closely with other R&D functions (electrical, optics, software, systems), Marketing, Clinical Affairs, and Quality & Regulatory. This position may require domestic or international travels up to 10% of the time

 Competencies:

Technical expertise:

  • Design: compact, miniature, light-weight opto-mechanical architectures
  • Design: de-sensitize optical designs to environmental influences (e.g. thermal, vibration, atmospheric)
  • EDA Tools: SolidWorks, FEA, Zemax
  • Reliability: de-rating analysis, Six Sigma (DFSS), failure analysis, physics-of-failure
  • Regulations: IEC 60601-1, IEC 60601-1-2, ISO 14971, FDA cGMP, QSR, ISO 13485, EU MDR, etc.
  • Solid Mechanical Engineering fundamentals and problem-solving skills up through system-level

 Documentation:

  • Schematics, architecture documents, requirements documents, technical reports
  • Characterization procedures, test procedures, and test fixtures
  • Verification & validation plans, protocols, and reports
  • Project plans, project schedules, risk / benefit / cost analysis

 Process:

  • Design control, quality system, risk management, dFMEA, PDP, CAPA
  • Mechanical design process from concept to architecture to volume production
  • Prototype bring-up and debug, bug tracking, functional verification, performance characterization
  • System development process – concept, schematics, system bring up and debug

 Work habits:

  • Strong communication and presentation skills
  • Communicate ideas and issues effectively to other team members and management
  • Participate in project teams in NPI, failure investigations, sustaining engineering, etc.
  • Strong multidisciplinary collaboration experience – EE, Optics, SW, ME, SE, QA, RA, Marketing, Clinical, etc.
  • Experience with team collaboration and project management tools
  • Work in a matrixed environment to meet company objectives
  • Actively learn to become the domain expert on our gas sensing devices

 Essential Functions:

  • Participate in project teams in NPI, failure investigations, sustaining engineering, etc.
  • Communicate ideas and issues effectively to other team members and management.
  • Create and document designs (e.g. schematics, drawings, test results, data analyses, PCB design etc.)
  • Build prototypes for feasibility, functionality, and performance assessments
  • Prepare design documents, requirements documents, architecture documents, technical reports, presentations, as required
  • Contribute to dFMEA, DFT, DFM, risk management, verification & validation plans and reports, etc.
  • Collaborate with cross-functional teams regarding standards compliance and global regulatory requirements (e.g. IEC 60601-1, IEC 60601-1-2, ISO 14971, FDA cGMP, QSR, ISO 13485, EU MDR)
  • Assists engineering team in problem solving issues
  • Mentor less experienced engineers
  • Additional responsibilities may be assigned, as required, by management

 Education and Experience:

  • Bachelor’s or Master’s Degree in Mechanical Engineering
  • 5 - 10 yrs of experience in medical device (capital equipment) or related fields (regulated industry preferred)
  • Technical lead on mechanical engineering programs
  • Strong working knowledge of hardware (mechanical, optical, electrical) and software / firmware
  • Experience in designing to comply with EMC and ESD requirements
  • High reliability designs, DFT, DFM, (medical devices preferred)
  • Compact, miniature, high-density designs, (medical devices preferred)
  • Knowledge of ASME Y14.5 Dimensioning and Tolerancing
  • Design verification test development, execution, report generation
  • In-depth knowledge of product development process and design control from concept to volume production
  • In-depth knowledge of quality assurance techniques, practices, ISO and Regulatory (FDA) compliance
  • In-depth knowledge of medical device regulations and standards (e.g. IEC 60601-1, EU-MDR, FDA cGMP)
  • Understanding of capnography or gas sensing products, applications, and technologies a plus
  • Six Sigma (DFSS) Green Belt certification with actual project experience a plus
  • Solid OEM / ODM / CM experience


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