Sr. Manufacturing Engineer is responsible for supporting production released assembly lines for instruments and accessories. Plan and deliver improvements in reliability, cost, manufacturability, and serviceability. Provide mechanical support as directed for cross functional team including electrical and software disciplines. Contribute with his/her technical skills in the areas of manufacturing, problem solving and training. Lead and schedule production line transfers.
Roles & Responsibilities:
- Lead and participate in initiatives focused on yield improvement, material cost reduction.
- Create budget estimates for Equipment, Fixtures and Tools, prototype designs and first article activities.
- Equipment, Fixtures and Tools reliability challenge and provide design improvements proposals.
- Equipment, Fixtures and Tools specification, documentation, procurement, maintenance, qualification and implementation.
- Manufacturing assembly line reliability and layout improvements, including proper line balance.
- Provide Design Engineering input for Design for Manufacturability (DFM) to ensure standardization across the assembly product and processes.
- Creation, revision and/or approval of manufacturing and engineering documentation, including:
- Engineering Change Orders (ECO's, BCO's, NCO's, MCO's, etc.)
- Work instructions (MPI's, IVI's, Acceptance criteria, etc.) Operating procedures (SOP's, DOP's, etc.).
- Lead and participate in Line and Product transfer initiatives.
- Other.
- Take responsibility for developing and maintaining compliance with the quality system. Address production line support as issues arise.
- Document (investigate, address root cause, and report) any variances, or concerns on all aspects of the manufacturing process through current notification processes (VR's, NCR's, PL's, etc.)
- Review, provide technical support and assign disposition to discrepant material or products and implement corrective actions to prevent recurrence.
- Evaluate and select suppliers for mechanical parts. Help resolve supplier quality issues. Involved in assembly lines or products transfers into our facilities, including planning, validation/verification and final implementation.
- Performs other duties as required.
- Travel: Position may require 5-10% travel, primarily within The United States.
Skills, Experience, Education, & Training:
- Able to work in night shift.
- Able to work in Nelson Industrial Park.
- Be of high character and energy with regard for detail. Demonstrate Mechanical and/or Process Engineering ability.
- Demonstrate ability in failure analysis and continuous improvement.
- BS degree in Mechanical Engineering or equivalent.
- Minimum 5 years mechanical or manufacturing engineering experience with Mid/high volume complex mechanism manufacturing.
- Able to read and understand mechanical and electrical drawings.
- Solid modeling experience (ProE, SolidWorks, or equivalent).
- Possess strong communication skills to interact with suppliers, other departments within the company (product development, planning, purchasing, regulatory, quality, etc.)
- MS in an engineering discipline.
- Prior experience with various sensor applications and technologies, including reliability and performance assessment.
- Prior experience working in an FDA/ISO regulated environment. Experienced in ISO 13485 or medical device manufacturing environment.
- Demonstrated ability to effectively design experiments.
- Prior responsibility for process, equipment, or product validation/verification.
- Prior experience with automated equipment, complex mechanism manufacturing, or robotics.
- Machine tool experiences a plus.
- Experience with ASME Y14.5 Geometric Dimensioning and Tolerance.
- Experience in Just-In-Time, Demand Flow Technology, and Lean Manufacturing techniques.
- High English level (+ 80 %).
Intuitive es un empleador que brinda igualdad de oportunidades de empleo. Proporcionamos igualdad de oportunidades de empleo a todos los solicitantes y empleados cualificados, y prohibimos cualquier tipo de discriminación y acoso, independientemente de su raza, sexo, condición de embarazo, orientación sexual, identidad de género, origen nacional, color, edad, religión, condición de veterano protegido o de discapacidad, información genética o cualquier otra condición protegida por las leyes federales, estatales o locales aplicables.
