- Good Understanding of ISO 13485 Quality System Standards, FDA Quality System Regulations, ISO 14971, IEC 62366 and/or other international medical device standards
- Advanced Technical Training in Quality Engineering principles, Risk Management, Ophthalmic Sciences and Technology, Systems Engineering and/or Process Excellence (Certified Six Sigma Black Belt) is preferred
- Responsible for developing/updating quality plan
- Prepare, execute, review and approve design verification test protocols and reports
- Determine statistically relevant sample sizes
- Able to lead risk management activities including creation/update of Risk Management Plan, Hazard Analysis, Design FMEA, Risk Benefit Analysis and Risk Management Final Report
- Creating appropriate harm/hazard analysis/health hazard assessment for issues potentially impacting patient outcomes
- Investigate, identify and implement corrective and or preventive actions to close design control CAPAs
- Assess design control procedure updates and determine product and business impact
- Lead projects related to major design control upgrades
- Engaging with project teams to gather and incorporate feedback to improve design control
- Prepare technical product documentation including design history files, drawings, bills of materials, test protocols and reports, engineering change orders (ECO), etc.
- Work with manufacturing engineer/process engineer to ensure necessary process controls are in place
- Work with manufacturing engineer/process engineer during process validation execution and protocol and report review and approval
- Assess impact of validations on SOPs, process sheets, FMEAs and Quality Control Plans
-
Design Control
1 week ago
TEPHRA Milpitas, United States: · Coordinate design Assurance activities in support of product development and life cycle processes between customer team and offshore team · • Good Understanding of ISO 13485 Quality System Standards, FDA Quality System Regulations, ISO 14971, IEC 62366 and/or other internati ...
-
Controls Design Engineer
2 weeks ago
AlfaTech San Jose, United StatesJob Description · Job DescriptionSalary: $70,000 - $80,000 annually · ______________________________________________________________________ · Design Engineer, Controls · About Us · At AlfaTech we believe in more than just engineering solutions; we believe in promoting a culture ...
-
Design Quality Control Lead
2 weeks ago
PGH Wong Engineering, Inc. San Jose, United StatesJob Description · Job DescriptionSalary: $124,800 to $148,000 · PGH Wong Engineering, Inc. has a proud and lengthy history of delivering innovative, challenging, and complex projects. PGH Wong was established in 1985 on its extraordinary foundation in systems engineering and is n ...
-
Principal System Control Plane Design Engineer
4 weeks ago
Cadence Design Systems, Inc. San Jose, United States Full timeAt Cadence, we hire and develop leaders and innovators who want to make an impact on the world of technology. · Hardware emulator is a complex embedded system used by many SoC, software and system design companies to validate their multi-billion designs prior to, during and aft ...
-
Controls Design Engineer
3 weeks ago
AlfaTech San Jose, United StatesAbout Us · At AlfaTech we believe in more than just engineering solutions; we believe in promoting a culture of agility, collaboration, and inclusion. As a leading consulting engineering firm, we provide thoughtful engineering design that is technologically forward thinking, inno ...
-
Controls Design Engineer
4 weeks ago
Alfa Tech Consulting San Jose, United StatesAbout Us · At AlfaTech we believe in more than just engineering solutions; we believe in promoting a culture of agility, collaboration, and inclusion. As a leading consulting engineering firm, we provide thoughtful engineering design that is technologically forward thinking, inn ...
-
Controls Design Engineer
1 week ago
Alfa Tech Consulting San Jose, United StatesAbout Us · At AlfaTech we believe in more than just engineering solutions; we believe in promoting a culture of agility, collaboration, and inclusion. As a leading consulting engineering firm, we provide thoughtful engineering design that is technologically forward thinking, inno ...
-
Controls Design Engineer
2 weeks ago
Alfa Tech Consulting San Jose, United StatesJob Description · Job Description Salary: $70,000 - $80,000 annually · ______________________________________________________________________ · Design Engineer, Controls · About Us · At AlfaTech we believe in more than just engineering solutions; we believe in promoting a cult ...
-
Design Control Process Leader
3 weeks ago
Intuitive Sunnyvale, United StatesCompany Description · At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints. · As a pioneer and market leade ...
-
Controls Design Engineer
2 weeks ago
LEDGENT Technology & Engineering - Roth Staffing Companies, L.P. Pleasanton, United StatesJob Title: · Controls Design Engineer ll · Location: · Pleasanton, CA · Direct Hire · JOB SUMMARY · The position requires the individual to apply their technical knowledge and any prior experience to produce controls project design, material selection, and development of sequen ...
-
Design Quality Control Lead
2 weeks ago
PGH Wong Engineering San Jose, United StatesJob Description · Job Description Salary: $124,800 to $148,000 · PGH Wong Engineering, Inc. has a proud and lengthy history of delivering innovative, challenging, and complex projects. PGH Wong was established in 1985 on its extraordinary foundation in systems engineering and i ...
-
Design Quality Control Lead
2 weeks ago
PGH Wong Engineering San Jose, United StatesJob Description · Job Description Salary: $124,800 to $148,000 · PGH Wong Engineering, Inc. has a proud and lengthy history of delivering innovative, challenging, and complex projects. PGH Wong was established in 1985 on its extraordinary foundation in systems engineering and is ...
-
Controls Design Engineer II
17 hours ago
Sunbelt Controls Pleasanton, United StatesJob Description · JOB SUMMARY: · The position requires the individual to apply their technical knowledge and any prior experience for the production of controls project design, material selection, and development of sequence of operation for lower to mid-level projects. In addit ...
-
Design Control Process Leader
1 week ago
Intuitive Sunnyvale, United StatesCompany Description · At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints. · As a pioneer and market leader ...
-
Controls Design Engineer
2 weeks ago
Ledgent Technology Pleasanton, United StatesJob Title: Controls Design Engineer ll · Location: Pleasanton, CA · Direct Hire · JOB SUMMARY · The position requires the individual to apply their technical knowledge and any prior experience to produce controls project design, material selection, and development of sequence of ...
-
Controls Design Engineer
2 weeks ago
Ledgent Technology Pleasanton, United States· Job Title: Controls Design Engineer · Location: Pleasanton, CA · Direct Hire · JOB SUMMARY · * Responsible for producing closeout documents at the completion of each project. · * Proficient level of computer skills and understanding of computer-operated systems and engineeri ...
-
Controls Design Engineer
1 week ago
Ledgent Technology Pleasanton, United StatesJob Title: · Controls Design Engineer ll · Location: · Pleasanton, CA · Direct Hire · JOB SUMMARY · The position requires the individual to apply their technical knowledge and any prior experience to produce controls project design, material selection, and development of seque ...
-
Controls Design Engineer
4 weeks ago
LEDGENT Technology & Engineering - Roth Staffing Companies, L.P. Pleasanton, United StatesThe position requires the individual to apply their technical knowledge and any prior experience to produce controls project design, material selection, and development of sequence of operation for lower to mid-level projects. · Responsible for producing closeout documents at the ...
-
Controls Design Engineer
2 weeks ago
Ledgent Technology Pleasanton, United States· Job Title: Controls Design Engineer ll · Location: Pleasanton, CA · Direct Hire · JOB SUMMARY · The position requires the individual to apply their technical knowledge and any prior experience to produce controls project design, material selection, and development of sequence ...
-
Nvidia Santa Clara, CA, United StatesNVIDIA is looking for a Senior ASIC Design Engineer for our Memory Controller team As a Senior ASIC Engineer, you'll join a group of hard-working engineers to craft and implement innovative Memory Controllers for our Tegra SoCsAt NVIDIA, you'll make a real impact in a multi-layer ...
Design Control - Milpitas, United States - TEPHRA
Description
:Coordinate design Assurance activities in support of product development and life cycle processes between customer team and offshore team
o BS or MS degree (Mechanical, Biomedical Engineering, or related technical field)
o Project management experience is required
o Minimum (6-8 years) of Quality experience in medical device industry
o ASQ Certification as a Quality Engineer is preferred
#J-18808-Ljbffr
