Sr. Medical Device Manufacturing Design Engineer (Min 5+ Years Exp/Must Have Exp In Catheters, Implants, Ancillary Products Or Similar)- Greencard Or Usc

Location: Campbell, CA

Salary: Market + + equity + benefits.

Description

• Component testing methods include tensile, fatigue, corrosion, burst pressure, and mock deployment. Documentation includes documenting build processes, writing test methods, and recording build/test data. Contributes both individually and as a team leader.
• Duties include being responsible for the development of a variety of manufacturing processes that include mechanical, electronic, and/or electro-mechanical assembly and testing.
• Component assembly methods include bonding, laser welding, adhesive, wiring, hand soldering, and crimping.
• The Sr. Manufacturing Engineer contributes to medical device product design, development, manufacturing, and testing in accordance with the company’s Quality System.

Responsibilities

• Design, execute, and analyze experiments using sound statistical methodology. Participate in risk management activities, including development and ownership of process FMEAs.
• Perform process optimization and manufacturing scale-up; develop and implement ergonomic improvements to the process.
• Improve manufacturing efficiency through planning and evaluation of workflow, space requirements and equipment layout.
• Design and validate fixtures and tools for manufacturing and inspection processes.
• Build finished implants, catheters, and ancillary products to support DV&V, animal testing, and clinical investigations
• Research, develop, modify, and test manufacturing methods and equipment; perform IQ/OQ/PQ validations and gauge R&R.
• Provide training to associates, technicians and assemblers; assisting other technical associates.
• Calculate production, labor, and material costs; manage and adjust production schedules to meet demand.
• Provide day-to-day manufacturing support and decision-making; troubleshoot assembly process issues as necessary; respond with urgency to process and equipment issues.
• Establish manufacturing and inspection procedures; prepare process validation protocols and reports; execute process validations; collect and analyze process data and trends and implement changes.
• Utilize required Quality System procedures; adhere to the Quality Policy and quality system requirements, including maintaining accurate documentation.
• Drive and provide support to quality processes and applying formal problem-solving techniques to determine root cause, and implementing solutions (non-conformance, CAPA, change management, audits, product complaint investigations, etc.).
• Support company goals and objectives, policies and procedures, and regulatory requirements (FDA regulations, ISO 13485, MDD, etc.).
• Assure product and process quality by designing test methods, performing process validations and process capability studies.
• Develop manufacturing processes by applying engineering knowledge and product design, fabrication, assembly, tooling, and materials.
• Prepare production forecasts; manage component and finished good inventory; schedule reorder points.
• Develop process documentation (e.g. MPI’s, LHR’s, WI’s, TPI’s, etc.)

Required Skills, Abilities & Experience

• Demonstrated ability to apply engineering fundamentals and statistical analysis to manufacturing process trending, improvement, and troubleshooting.
• Familiarity with FDA QSR, ISO 13485, and the MDD
• Experience managing production, including creating forecasts and managing inventory
• Experience in taking a product from development to commercialization
• Experience developing and executing process and/or equipment validations.
• Experience with SolidWorks.
• 5+ years of previous medical device experience, preferably in the medical device industry.
• Bachelor’s in Mechanical Engineering, Industrial Engineering or equivalent experience.
• Preferred
• Proven ability to prioritize, initiate, and drive projects to completion.
• Understanding and exposure to principles of product design, manufacturing, risk analysis, and product testing/reporting.
• Assembly, manufacturing, and testing of microelectronics
• Experience in laser welding
• Experience with quality system documentation requirements and test protocols.