Controls Engineer- Medical / Pharma Industry

Controls Engineer

Location : North Haven, CT

The Controls Engineer will provide expertise in the specification, development, validation and commissioning of production assembly tooling and automation equipment in support of New Product Development (NPD) efforts for innovative surgical devices.

Essential Functions :

• Plan and develop technical and financial specifications for Reliability, Prototype and Production assembly tooling and automation equipment.
• Participate in R&D Engineering meetings and Quality Design FMEA meetings.
• Complete and document Design for Assembly (DFA) analyses and drive effective resolutions with R&D pertaining to any identified risks.
• Provide input to the Assembly Tooling Strategy and Process FMEA, particularly the integration of controls to mitigate high risks.
• Contributor to the Capital Expense Request (CER) process, specifying costs for assembly equipment, with consideration to product standard cost targets and capacity demands.
• Key team member in the supplier selection process, including the review of technical proposals.
• Generate electronic Purchase Requisitions based on quotations from selected suppliers for design, build and acceptance testing of capital assembly equipment.
• Strategic supplier contact during assembly equipment design, fabrication and acceptance testing, providing technical support and project management resources.
• Conduct assembly equipment design reviews, ensure supplier adherence to fabrication specifications and safety requirements, and direct execution of factory and site acceptance testing protocols.
• Initiate and execute validation protocols to support assembly equipment release for production (IQ, MSA, OQ, PQ).
• Program and troubleshoot PLC's, HMI's, Vision Systems and Data Acquisition Systems on new and existing production equipment.
• Provide technical training and support to Maintenance and Manufacturing Engineering personnel in the operation and maintenance of automated assembly equipment.
• Investigate and develop new controls technologies to continuously improve production operations.
• Execute Controls Engineering product transfer deliverables from Pilot to the receiving Plant.
• Advise Management of any unmitigated risks and / or developments that could affect TTM or standard cost.

Requirements :

Compensation : $50.00 - $55.00 per hour