Job Description

We are seeking an exceptional Senior Mechanical Engineer to design, develop, and validate semi or fully automated equipment that is used for the scale-up of high volume, disposable devices. Your role is to find creative and sound engineering solutions to challenging problems with a strong focus on quality, reliability, and execution. This is a hands-on position that requires interaction and collaboration with a cross-functional team including Engineering, Manufacturing, Biology, Quality, Facilities, and Sustaining.

Requirements

• Develop concepts and ideas for improving existing tooling as well as creating new tooling including semi-automation where applicable
• Evaluate the current manufacturing processes & workflows, identify opportunities for improved performance/throughput by applying knowledge of product design, fabrication, assembly, tooling, and materials as well as soliciting feedback from operators
• Take full ownership of the design, create User Requirements Specification (URS), conduct concept reviews, show proof of concept through prototyping/supporting test data, coordinate with appropriate stakeholders for successful verification/validation, launch, and documentation
• Create 3D models, engineering drawings and bills of materials
• Create comprehensive work instructions and manufacturing SOP’s
• Create verification/validation protocols (IQ,OQ,PQ), lead/support the execution activities, generate relevant data and provide corresponding documentation and reports
• Participate in design FMEA and plan steps for mitigating risks
• Establish a working relationship with outside vendors, machine shops, contract manufacturers and manage the work accordingly
• Comply with company’s policies and guidelines regarding design control, validation activities and documentation

Requirements

• Bachelor’s Degree in Mechanical Engineering
• 5-7 years hands-on, relevant experience
• In-depth experience with complex mechanical/electromechanical design
• Extensive experience with precision mechanisms, pneumatics, servo systems, tooling/fixtures, and mechanical components such as motors, belts/pulleys, gears, actuators, sensors, etc.
• Experience with creating engineering drawings, BOMs and product specifications
• Deep knowledge of material properties, heat treatment, and surface finish
• Proven track record with Medical Device Manufacturing Methods/Procedures, FDA regulations, ISO, cGMP, and QMS standards
• Good understanding of DFM and lean manufacturing
• Excellent verbal, written, presentation and interpersonal skills
• Strong analytical and problem-solving skills
• Knowledge and/or hands-on experience with machine shop tools
• Deep knowledge of GD&T as well as proficiency with SolidWorks
• Creative, self-motivated and flexible to work in a small company environment and assume a wide variety of tasks

Preferred Qualifications

• Master’s degree in Mechanical Engineering or equivalent
• Knowledge/experience with plastic injection molding
• Knowledge/experience with DOE, SPC, JMP /Minitab
• Experience with metal stamping, laser cutting and chemical etching
• Familiarity with and sterilization process and aseptic environment
• PLC programming

Travel

Up to 10%

Job Categories: Mechanical Engineer. Job Types: Full-Time.

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