KH
Engineer III
Katalyst Healthcares & Life Sciences
🇺🇸 United States
On-site
5 months ago
- Regulatory Compliance
- MS Office
- MS Project
- SolidWorks
- Minitab
- JMP
- Lean Six Sigma
- 5S
- GD&T
- CAD
- Risk Management
- Six Sigma
5 months ago
- Demonstrate creative 'out of the box' thinking to solve difficult problems and develop new technologies to achieve project goals.
- Design and execute design of experiments and fixture development to support feasibility, development, and verification stages of product development to meet project timelines and all relevant regulatory compliance requirements.
- Define, develop, and validate/transfer test methods.
- Create verification plans, protocols, records, and reports. Support investigations and issue resolutions.
- A degree in an engineering field (mechanical, materials, packaging, bioengineering): BS or equivalent education with 5-10 years of experience; MS or equivalent education with 3+ years of experience.
- Strong expertise in Design Verification for Medical Devices and experience working in a regulated environment in compliance to 21 CFR 820 and MDR.
- Significant background in engineering testing and analysis including:
- Direct experience of test equipment validation (IQ, OQ, PQ) is required.
- Must be able to demonstrate relevant experience in statistical analysis.
- Documentation experience including standard operating procedures (SOPs), technical reports, and design verification plans/protocols/reports.
- Proficiency in MS Office, MS Project, Solidworks, Minitab or JMP.
- Lean Six Sigma, 5S experience desired.
- Good communication skills, both written and oral. Ability to prepare technical reports and presentations.
- Experience creating engineering drawings, proficiency with GD&T dimensioning, CAD design (SolidWorks) and tolerance stack analysis.
- Experience with ISO 13485 and 14971 quality system and risk management principles.
- Experience with design control, DHF documentation, and good manufacturing/documentation practices.
- Experience with fixture design, fixture development, test method validation.
- Experience with statistical software (Minitab or JMP), Six Sigma statistics and Design of Experiments.
Engineer III · Katalyst Healthcares & Life Sciences