Manufacturing Process Engineer (electrical​/Mechanical

Manufacturing Process Engineer (electrical/Mechanical)

Immediate need for a talented Manufacturing Process Engineer (electrical/Mechanical). This is a 06+months contract opportunity with long-term potential and is located in Glens Falls, NY (Onsite).

Key Responsibilities:

• Leads the vertical integration of manufacturing processes into the existing Glens Falls manufacturing environment, including the development, qualification, and validation of applicable processes
• Monitoring and reporting of project progress to an established timeline
• Perform mechanical/electrical testing and gauge repeatability and reproducibility (R&R) studies.
• Statistically analyse data, including process capability and Design of Experiments (DOE).
• Trouble-shoot processes, equipment, and quality systems and develop/implement corrective and preventive actions.
• Lead problem solving activities using analysis tools to identify root cause and implement robust solutions.
• Author change requests, validation documentation, and technical reports.
• Coordinate activities with Mexico site who will be receiving the transferred component and validation the final product.

Key Requirements and Technology

Experience:

• Process Validation (IQ/OQ/PQ) & Qualification
• Medical Device Manufacturing exp
• Manufacturing Process Development & Technology Transfer
• Quality Systems & Statistical Analysis-Strong knowledge of QMS, FDA/GMP, Change Control, DOE, Process Capability, Gauge R&R, CAPA, Root Cause Analysis, and validation documentation.
• Project Management
• Bachelors degree in Engineering or other technical field of study, plus a minimum of two (2) years engineering experience.
• Or, minimum of seven (7) years engineering experience in a manufacturing environment in lieu of a degree.
• Thorough knowledge of Quality Management Systems (QMS), Process and Component Qualification requirements, and Change Control Processes.
• Ability to clearly articulate ideas and information both verbally and in writing.
• Confirmed ability to work collaboratively within a team and contribute to team-building efforts.
• Demonstrates initiative and the ability to think independently, driving tasks & projects forward without constant supervision.
• Capable of making informed and timely decisions, considering various factors and potential outcomes.
• Strong skills in identifying issues and developing effective solutions to resolve them.
• Knowledge of safety standards and ergonomic practices to ensure a safe and comfortable working environment.
• Ability to oversee projects, ensuring they are completed on time and within budget.
• Skills in organizing & managing logistics, ensuring efficient planning & execution of tasks.
• Proficiency in using computer software Microsoft Office applications, statistical analysis
• Applicants must be authorized to work for ANY employer in the US. We are unable to sponsor or take over sponsorship of employment visa at this time.
• Experience in a regulated environment.
• Regular typing and computer work performed daily. Requires occasional light physical effort (e.g., prolonged standing, sitting, bending, stooping reaching and/or lifting of light items - up to 30 lbs.).
• 2-10 years experience Validation, Process Development. Pm experience. Taking this project from infancy through to Validation.
• 50% in the office and 50% on the floor in the manufacturing facility.
• Highly regulated industry exp.
• Med device, Pharma experience required