Position Summary:
Responsible for supporting product transfer, instrument manufacturing, troubleshooting, failure analysis, quality improvement, process enhancement, cost reduction, engineering evaluation and system improvement.
Position Responsibilities:
- Support and drive activities to ensure successful product transfer into manufacturing.
- Drive troubleshooting, failure analysis, root cause analysis, issues closure and corrective action processes as required.
- Perform instrument setup, calibration and final system integration test.
- Establish and maintain databases of instrument failures and defects.
- Perform data trending analysis, construct and execute design of experiments to address yield and quality issues.
- Drive and implement process improvements and product sustaining activities to meet the production goals.
- Drive maintenance and improvement activities on test fixtures and equipment.
- Drive and implement cost reduction activities by perform engineering evaluation to qualify new or improved materials, processes and products.
- Apply various analysis techniques, such as FMEA and statistical analysis to optimize product quality and minimize cost, providing all calculations, performance data, and drawings required on new and existing products.
- Manage and coordinate Engineering Change Order implementation activities including scrap analysis, material disposition, update work instructions and test requirement changes.
- Documentation responsibilities include, but not limited to, generating detailed engineering drawings, Bill of Materials, test reports, assembly procedures and design validation plans.
- Work closely with contract manufacturing partners and key suppliers to ensure smooth transition of quality products from development into manufacturing.
- May require frequent travels to US.
All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities.
Position Requirements:
- Bachelor’s degree or Master in Mechanical or Electro-mechanical Engineering.
- 3+ years of engineering experience in mechanical or electro-mechanical based products for commercial and industrial markets.
- Good working knowledge and experience in mechanism design and electro-mechanical systems.
- Strong organizational skills, attention to detail and accuracy, and the ability to work independently in a team environment are essential.
- Good knowledge of GD&T, plastic & sheetmetal tooling, casting, mechanism, stress analysis, mechanics, machining and standard manufacturing processes.
- Candidate must be able to effectively interface well with the manufacturing and service organization, and has a proven track record of transferring products to manufacturing.
- Must possess good analytical and troubleshooting skills.
- Proficient in engineering tools such as, statistical analysis, design of experiments, product and process capability analysis.
- Proficient in Solidworks or 3D CAD tools.
- Experience with FDA regulated medical device product development preferred.
- Product development experience in the life sciences, biotech, biomedical or nanotechnology industries preferred.