Company:
ESR Healthcare
Location: San Jose
Closing Date: 25/10/2024
Salary: £150 - £200 Per Annum
Hours: Full Time
Type: Permanent
Job Requirements / Description
Senior Mechanical Engineer - San Jose, CA
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.
Responsibilities
- 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 SOPs.
- 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.
Minimum Qualifications
- 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 sterilization processes and aseptic environment.
- PLC programming.
Travel
Up to 10%
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ESR Healthcare