This is Uday from Intellectt Inc. One of our Medical Device clients are looking for Sr Engineer in California following is the Job Description for the position, If you are interested send your updated resume to uday@intellectt.com or you can give me a direct call at +1 732-201-2258.
Role: Sr Engineer
Location: Irvine, CA - 92614
Duration: 9 Months
Job Duties
The main function of a quality engineer is to apply engineering theory and principles to problems of industrial layout or manufacturing production. A typical quality engineer has the ability to make engineering drawings, write risk analysis documents and read and interpret drawings.
Key Responsibilities
Apply knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards' systems/procedures to optimize product development, internal and external device manufacturing, and device distribution.
Lead identification, development, and optimization of complex manufacturing processes using engineering methods (e.g., Six Sigma and Lean manufacturing tools) for design for manufacturing and continuous process improvement initiatives.
Identify opportunities and implement solutions for redesign/design of complex equipment, new technologies (including automation and software), tools, fixtures, etc., to improve manufacturing processes and reduce overall process/product risk profile.
Oversee prototype builds, train operators and inspectors, develop in-process inspections, validate in-process inspections, and manage defect codes.
Drive the development and manage the execution of complex experiments and tests (including writing and executing protocols) to create, validate, and improve products (including evaluation of source materials and suppliers) and establish robust manufacturing processes/methods based on engineering principles. Ensure completion of comprehensive process validations (IQ/OQ/PQ), including analyzing results and developing reports. Collaborate with cross-functional team members to facilitate project success and on-time completion.
Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes.
Develop technical content of risk management files.
Lead in the investigation of complex manufacturing product quality and compliance issues (e.g., SCAR, CAPA, non-conformances, audit observations) for all supplier production processes and based on engineering principles. Analyze results, make recommendations, and develop reports.
Train, coach, and guide lower-level employees on more complex procedures. Oversee quality support tasks; give instruction to engineers/technicians on conducting tests; train engineers/technicians and provide feedback; and may coordinate engineers/technician work.
Education & Skills
Bachelor's degree in engineering required.
5-7 years’ experience required
Creativity, verbal and written communication skills, analytical and problem solving ability.
Team player and detail oriented.
Ability to make sketches, engineering drawings and common computations.
Ability to read and interpret blueprints, technical drawing, schematics and computer-generated reports.
Previous experience with computer applications and software related to engineering field, such as Computer Aided Design (CAD)
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Engineering and Information Technology
Industries
Medical Equipment Manufacturing, Biotechnology Research, and Pharmaceutical Manufacturing
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