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.
• Able to rapid prototype custom, in-house made machines.
• 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.

Education and/or Job Experience

• Bachelor’s Degree in Mechanical Engineering.
• 2 - 5 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, SCADA, Ladder Logic preferred.