SysMind Tech
Manufacturing Validation Engineer
SysMind Tech, Irvine, CA, United States
Relevant Experience
(in Yrs)
4+ years of experience & demonstrated proficiency in manufacturing validation & providing ongoing technical support is preferred with evidence of continued self-development.
Work experience in the Medical Device industry.
4+ Years
Roles & Responsibilities
Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, the duties and responsibilities for this position are:
Generic Managerial Skills
• Strong communication skills. Candidates must be highly proficient in reading, writing, and speaking English language.
• Ability to multitask, including ability to understand customer requirements, retrieve relevant information, and provide responses satisfactorily and with immediacy is required.
• Ability to understand and follow complex written procedures is required.
(in Yrs)
4+ years of experience & demonstrated proficiency in manufacturing validation & providing ongoing technical support is preferred with evidence of continued self-development.
Work experience in the Medical Device industry.
- Technical/Functional Skills
- Knowledge of Medical Equipment manufacturing processes
- GMP (Good Manufacturing Practices) & ISO (International Organization for Standardization) 9000 and regulatory affairs
- Ability to specify & qualify Assembly, Tooling, Gage equipment and Fixture equipment
- Knowledge in the areas of Process validation, Statistical process control, Product design & DFMA (Design for Manufacturing & Assembly), Plastic & metallic materials & processing and Applied Statistics
- Knowledge of biocompatibility in medical device industry
- Demonstrated ability to interpret the engineering drawings i.e., GD&T (Geometric Dimensioning &Tolerancing)
- Understanding of Process development & design and Quality Function Deployment
- Excellent Analytic problem solving, Broad business planning, Cross-functional integration skills
- Demonstrated understanding of Ergonomics and financial analysis skills preferred
- Excellent Interpersonal / communication skills, Organizational / planning and Project management skills preferred
- Understanding of Marketing & market research strategies
- Personal computer skills, Windows: word processing, project planning,
- presentation, e-mail, web browsers & spreadsheet software
- Training & experience in Good Manufacturing Practices & ISO 9000 is required.
4+ Years
Roles & Responsibilities
Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, the duties and responsibilities for this position are:
- Train mechanics & operators on internal processes & equipment requirements
- Perform Installation Qualification, Operational Qualification, Process Qualification
- Develop validation protocols, qualify first articles, complete process capability studies & process validation on both internal & supplier processes using appropriate statistical techniques
- Prepare reports as per project requirement
- Actively participate in setting overall project objectives, direction & contributing in
- Work with R&D as needed to support process development, process improvements and process transfer activities
- Can travel to plant site at Mexico if required
- Know & follow policies & procedures related to work activities performed
- Complete training in area of responsibility within allowed time-period and periodic retraining in areas such as safety & environmental
- Follow all company safety policies & other safety precautions within work area.
Generic Managerial Skills
• Strong communication skills. Candidates must be highly proficient in reading, writing, and speaking English language.
• Ability to multitask, including ability to understand customer requirements, retrieve relevant information, and provide responses satisfactorily and with immediacy is required.
• Ability to understand and follow complex written procedures is required.