Job Title: Â Â Â Â Â Â Â Principal R&D Engineer
Client: Â Â Â Â Â Â Â Â Â Â Â Medical Device Manufacturing Company
Duration: Â Â Â Â Â Â Â 8.5 Months (Possibility of Extension)
Location: Â Â Â Â Â Â Â Tempe, AZ 85281
Shift: Â Â Â Â Â Â Â Â Â Â Â Â Â Â 1st Shift
Description:
- Lead the development, validation, and optimization of medical device manufacturing processes.
- Design and execute process characterization, validation (IQ/OQ/PQ), DOE, and TMV activities.
- Analyze manufacturing data using statistical methods to drive process improvements and solve complex engineering problems.
- Collaborate with cross-functional teams to support product development, manufacturing readiness, and commercialization.
- Conduct root cause investigations and implement corrective actions using DMAIC, 5 Whys, and Lean Six Sigma methodologies.
- Ensure compliance with quality management systems, regulatory requirements, and validation standards.
- Lead technical projects, mentor team members, and communicate project progress, risks, and solutions.
- Support research, product development, and continuous improvement initiatives for medical devices.
Required Skills:
- Process Development & Validation (DOE, IQ/OQ/PQ, TMV)
- Statistical Analysis
- Root Cause Analysis
- Medical Device Manufacturing
- Cross-Functional Project Leadership
- Quality Management Systems (QMS)
- Technical Problem Solving
- Project Management
- Risk Management
- Technical Documentation
Preferred Skills:
- HPLC, LCMS, FTIR, Mass Spectrometry
- Lean Six Sigma / DFSS / DRM
- Green Belt Certification
- Technical Writing
- Investigation & CAPA
- Medical Device Regulatory Compliance
Education:
- Advanced degree in Mechanical Engineering, Biomedical Engineering, Materials Science, Physics, Chemistry, Chemical Engineering, or a related engineering/science discipline.
Experience:
- 7+ years of relevant R&D or manufacturing engineering experience, or
- 5+ years of relevant experience with an advanced degree.
- Experience in medical device process development, validation, and cross-functional project leadership is required.
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