Senior Manufacturing Engineer

Job Description

Job Description

Job Summary: Develop processes for new products to be transferred into production. Apply Lean principles to drive process efficiency improvements and cost reductions. Support Production daily so that all operations function in a safe and efficient mode. Perform maintenance and repairs to process equipment as needed.

Duties/Responsibilities:

• Develop detailed instructions under process development that can be translated into working assembly procedures.
• Working from drawings, specifications, and assembly procedures, effectively train production operators.
• Design, create, test and document measurement and assembly fixtures.
• Analyze and plan workflow, equipment placement and space requirements for new production layouts and also improve existing manufacturing efficiencies.
• Ensure that manufacturing equipment is operating in a safe and effective manner. Define and perform preventive maintenance and repair as needed.
• Ensure that output of the manufacturing processes is at a level according to defined standards.
• Monitor production scrap and analyze rejects.
• Manage and resolve production issues as they arise day to day.
• Identify and resolve repetitive and major production issues that are adversely affecting department performance.
• Lead and compose a cross-functional Process Failure Mode and Effect Analysis (pFMEA).
• Support new product introductions as assigned by partnering with New Product Development engineers and participate in project team meetings.
• Possess statistical competencies to conduct multi-factorial Design of Experiments, design and execute Process Validations, and present results demonstrating process capability.
• Assist New Product Development engineers in the design of basic fixtures for assembly, e.g. holding fixtures, cutters, go/no-go gauges.
• Working with an assigned Project Engineer to the product line, identify and implement continuous improvements regarding assembly techniques and equipment, improving First Pass Yields and reducing cycle time and/or scrap.
• Must maintain training to all current Next Phase Quality Documents, including the Quality Manual and all SOP’s as assigned.
• Provide support in completing activities as assigned to resolve safety issues throughout the plant.
• Ability to work from home on occasion with advanced approval.

Required Skills/Abilities:

• Ability to read and interpret product and component 2D drawings, equipment schematics (electrical, pneumatic) and have a basic understanding of GD&T.
• Sound mechanical/electrical skills and an understanding of basic machinery principles.
• Poses a basic understanding of statistics and has the ability to conduct statistical analysis with statistical software, Minitab preferred.
• Microsoft Office Suite, including Word, Excel, PowerPoint, Visio.

Education and Experience:

• BS in Mechanical, Manufacturing, Industrial, Electrical Engineering or a related Engineering discipline.
• 5-7 years of production support and process development experience, preferably in the medical device field.
• Familiarity and prior experience working under ISO 13485:2016, ISO 14971:2007 and 21CFR Section 820 (FDA QSR).

Physical Demands:

• Ability to lift 40 pounds.
• Working on computer workstation for extended periods.
• Stand on a production line for extended periods.

Working Hours:
Monday - Friday
8:00am - 5:00pm