Principal R&D Engineer in Tempe
Job DescriptionJob Description
Job Title: Principal R&D Engineer
Client: Medical Device Manufacturing Company
Duration: 8.5 Months (Possibility of Extension)
Location: Tempe, AZ 85281
Shift: 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
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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Company DescriptionAs a leading contract, contract-to-hire and professional placement firm, Three Point Solution understands the importance of aligning our client with the right resource at the right time. We are committed to the highest caliber of service that will benefit our clients, candidates and employees. Unlike large, corporate style recruiting firms, we commit to individualized attention that uniquely positions us to bridge the communication gap between recruiter, employer and candidate. Our goal is to cultivate and maintain true partnerships with our clients and candidates.Company DescriptionAs a leading contract, contract-to-hire and professional placement firm, Three Point Solution understands the importance of aligning our client with the right resource at the right time. We are committed to the highest caliber of service that will benefit our clients, candidates and employees. Unlike large, corporate style recruiting firms, we commit to individualized attention that uniquely positions us to bridge the communication gap between recruiter, employer and candidate. Our goal is to cultivate and maintain true partnerships with our clients and candidates.