Location: North Haven, CT (Onsite 5 Days)
Duration: Long Term
Job Summary :
Candidates with a MedTech/Medical Devices/Life Sciences background will be an advantage.
Job Description:
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 suppliers 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 control 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:
- BS Electrical Engineering, Mechanical Engineering, or Equivalent
- MS Electrical Engineering, Mechanical Engineering
- Min 5 yrs. applicable experience
- Significant electrical controls and automation design experience.
- Proficiency in PLC (Allen Bradley), HMI, Vision System (Cognex), and Data Acquisition System (LabVIEW) programming and troubleshooting.
- Extensive knowledge in the application of machine motion controls, servo, and pneumatic.
- Extensive knowledge of electrical, pneumatic, and machine guarding safety standards.
- Experience in equipment risk assessments and mitigation plans.
- Experience in Lean Design and Manufacturing.
- Demonstrated knowledge of DFA, PFMEA, IQ, MSA, OQ, and PQ.
- Proven history of driving automation strategy and implementation in the development and commercialization of complex assemblies.
- Strong Project Management skills.
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