Katalyst Healthcares and Life Sciences
Job Description:
The Senior Engineer position within the Science and Technology (S&T) organization is responsible for the development, improvement, and verification of electro-mechanical medical devices. This technical expert will, with little supervision, primarily apply engineering knowledge and ingenuity in the execution of design improvements.
Responsibilities:
Manage device design changes by interfacing with cross-functional teams both at manufacturing partners and within Client. Team members have full awareness of the potential consequences (defects and failure modes) of design changes to electromechanical drug delivery devices. Mitigates risk through strong technical acumen, detailed planning, and engineering confidence testing. Verification testing (planning, fixture development, test method validation, protocol development, and test execution). The team members will be responsible for multiple, often concurrent, projects including those involving external development partners. Propose device refinements based upon patient feedback, manufacturing records, and feedback from other stakeholders. Conduct analyses (e.g. calculations, tolerance analysis, etc.) as needed to improve product and component designs. Lead and/or participate in root cause investigations and design solutions for complex engineering problems. Responsible for compliance with applicable procedures, regulations, and standards (e.g. IEC 60601-1:2020, ISO 10993-1:2018). Ensures quality and effectiveness of projects through sound design, early risk assessments, and implementation of fallback strategies. Maintains device history file. Some travel may be required. Requirements:
bachelor's degree in engineering with a desired 8+ years of significant engineering experience. post-graduate education / degree is desired and may contribute towards the desired years of experience. Has a career history marked by a consistent series of technical contributions and accomplishments. I interact well with diverse groups within engineering and maintain strong working relationships with internal and external collaborators. Proficient in SolidWorks'. Top 3-5 skills:
Design Verification of electromechanical devices. Infusion pump or on body infuser development or sustaining engineering experience. uthorizing test plans, protocols, and reports. Good documentation practice. Cross-functional collaboration.
Manage device design changes by interfacing with cross-functional teams both at manufacturing partners and within Client. Team members have full awareness of the potential consequences (defects and failure modes) of design changes to electromechanical drug delivery devices. Mitigates risk through strong technical acumen, detailed planning, and engineering confidence testing. Verification testing (planning, fixture development, test method validation, protocol development, and test execution). The team members will be responsible for multiple, often concurrent, projects including those involving external development partners. Propose device refinements based upon patient feedback, manufacturing records, and feedback from other stakeholders. Conduct analyses (e.g. calculations, tolerance analysis, etc.) as needed to improve product and component designs. Lead and/or participate in root cause investigations and design solutions for complex engineering problems. Responsible for compliance with applicable procedures, regulations, and standards (e.g. IEC 60601-1:2020, ISO 10993-1:2018). Ensures quality and effectiveness of projects through sound design, early risk assessments, and implementation of fallback strategies. Maintains device history file. Some travel may be required. Requirements:
bachelor's degree in engineering with a desired 8+ years of significant engineering experience. post-graduate education / degree is desired and may contribute towards the desired years of experience. Has a career history marked by a consistent series of technical contributions and accomplishments. I interact well with diverse groups within engineering and maintain strong working relationships with internal and external collaborators. Proficient in SolidWorks'. Top 3-5 skills:
Design Verification of electromechanical devices. Infusion pump or on body infuser development or sustaining engineering experience. uthorizing test plans, protocols, and reports. Good documentation practice. Cross-functional collaboration.