Cynet Systems Irvine, CA
We are looking for Senior R&D Sustaining Engineer (Design Verification / Validation) for our client in Irvine, CA
Job Title: Senior R&D Sustaining Engineer (Design Verification / Validation)
Job Location: Irvine, CA
Job Type: Contract
“W2 candidates are encouraged to apply. We are unable to sponsor H1b or work with third-party candidates at this time.”
- Applies knowledge of R&D engineering technical principles and client’s systems/procedures to optimize design/product development.
- Identify and ensure implementation of opportunities to optimize/improve product design verification and product design validation processes including using engineering methods (e.g., SIX Sigma and LEAN methods) employing technical design skills to re-design/design of and ensure equipment, tools, fixtures, etc are up to standards.
- Develop complex experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes; analyze results, make recommendations, and develop reports.
- Analyze and resolve complex design and manufacturing issues (e.g., CAPA, non-conformances, audit observations).
- Develop training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes.
- Lead and establish project plans to ensure deliverables are completed to customer’s expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.).
- Other incidental duties assigned by Leadership.
- Proven expertise in usage of MS Office Suite including MS Project; CAD experience preferred (if applicable).
- Strong documentation, communication (e.g., written and verbal), and interpersonal relationship skills including consultative and relationship management skills.
- Basic understanding of statistical techniques.
- Previous experience working with lab/industrial equipment required (if applicable).
- Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering.
- Strong problem-solving, organizational, analytical, and critical thinking skills.
- Substantial understanding of processes and equipment used in assigned work.
- Good leadership skills and ability to influence change.
- Knowledge of applicable FDA regulations for the medical device industry.
- Strict attention to detail.
- Ability to interact professionally with all organizational levels.
- Ability to manage competing priorities in a fast-paced environment.
- Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects.
- Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control.
Education and Experience:
- This job requires a Bachelor’s Degree in Engineering with 4+ years of experience in medical industry.
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