ISO 13485 Registered

Employment Opportunities

Sr. Mechanical R&D Engineer

Stellartech is looking for a Mechanical Engineer to join our Team.

Responsibilities:

  • Create and/or translate customer/management requirements into measurable product specifications.  Additionally, assist with the application of collateral requirements for such products or subsystems (e.g. ASME pressure vessel requirements, IEC 60601 requirements, etc.).
  • Lead the effort to determine product and major sub-system performance requirements, identifying the necessary resources, and preparing development plans that accomplish product development tasks.
  • Responsible for the complete design and development of major subsystems or significant portions of the product.  Consider the technical requirements for design activities, including loading (mechanical {stress, pneumatic, frictional, etc.}, electrical {electric potential, current carrying capacity, field influence}), user, environmental, performance (stress-strain limitations and requirements, cyclic stress, charge-discharge cycles, etc.), external (biocompatibility, sterilization, shipping), and implements solutions that address these requirements.
  • Assist with completion of development activities for product marketing including packaging design and testing, labeling, sterilization validation protocols and execution, materials selection, and development of verification and validation protocols.
  • Coordinate and perform design verification and validation activities for the product and major subsystems.
  • Assist with and/or prepare regulatory agency documentation to support approvals (e.g. summary test reports, Risk Management documents, etc.).
  • Perform or assist with transfer into manufacturing, including equipment, tooling and fixture design and fabrication, process development, operator training and process validation.
  • Lead the effort to create and/or assist with manufacturing documentation, including Device Master Records, Manufacturing Procedures, Quality Instructions, and Test Procedures.  Review them for completeness and effectiveness and suggest improvements if not adequate to ensure desired output.  Monitor output to ensure the design requirements are realized.  Intercede when the results are not as expected to ensure Stellartech only releases high quality products that meet the specifications and regulatory requirements.
  • Perform and/or assist with training of manufacturing and quality engineers, assemblers, technicians, and other support personnel.
  • Create and/or augment documentation in Design History File.
  • Maintain records of ideas, developments, and test results in a bound notebook.
  • Assist with preparation of documentation to support proprietary information development.

Skills & Qualifications:

  • BS in Mechanical Engineering or equivalent field of study required (MS preferred)
  • 6-10 years of medical device design, development and manufacturing experience required
  • Team-oriented professional with good interpersonal skills who is hands-on with a ‘high energy’ approach to work
  • Ability to communicate ideas and information clearly and effectively, i.e. good verbal and writing skills.
  • Ability to prioritize and execute tasks in a timely manner without direct supervision

To inquire about these opportunities, please contact us at jobs@stellartec.com

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