Senior Design Quality Engineer
San Jose Metro Area, CA
- Applies intensive and diversified knowledge of design principles, practices, and implementation in complex systems and assignments.
- General responsibilities include, assisting with design concept generation, participating in design reviews, reviewing development protocols, and testing, to assess performance against design specification.
- Additionally, the candidate will review reliability testing, and assist in the risk assessment of system interactions. This role will make independent decisions.
- The ideal candidate will consult and assist in the development of manufacturing processes and procedures, ensuring appropriate design transfer.
- Responsible for developing, implementing, and continuously improving defined processes which provide a methodical and systematic approach to ensuring that new and existing products and processes are effectively characterized and controlled prior to, and after launch.
- Facilitates and consults for risk management policies, procedures, and practices, which consolidate regulatory and quality system requirements with business goals resulting in an effective and efficient risk management system.
- Practices and mentors in the use of company concepts, policies and procedures, familiar with and follows standard practices.
- Applies functional expertise routinely on the job.
- Receives general direction and exercises considerable discretion as to work details.
- Contributes to the definition and timely achievement of overall project goals.
- Participates in efforts to define new components, products or processes.
- Identifies and implements improvements to work processes.
- Designs, plans and executes project related tasks.
- Consults and provides training for areas of statistical quality control such as SPC, Process capability, DOE, etc.
- Assures experimental quality through sound, independent, experimental design.
- Participates on cross functional technical teams.
- Provides technical direction and feedback to others.
- Participates in project planning, process updates and contributes to experimental design.
- Monitors work to ensure quality, and continuously promote Quality First Time.
Skills and Abilities:
- Demonstrates success in technical proficiency, creativity, collaboration with others and independent thought. Expert knowledge of applicable regulations and standards, including FDA QSR Part 820, ISO13485
- Expert knowledge of Quality engineering principles and concepts.
- Experience in medical device, including software, reagents, and assay development, design control process.
- Need software and medical device development understanding, partnered with Design Control regulations
BS in a directly related discipline. Advanced studies or training.
Typically requires a minimum of 8 years of related experience.