Systems Engineer
actions. Implement design changes that sustain existing products that are in the market Create DHF (Design History File...
actions. Implement design changes that sustain existing products that are in the market Create DHF (Design History File...
or participate in audits, as needed. Support external regulatory audits as needed. Support DHF compliance assessments to ensure...
, or other production issues encountered during NPI. Works with project teams to produce DHF reports, verifications and validations...
during product or supplier changes Maintain DHF, design input / design output, external requirements, and risk management... external standards and implement product requirements and testing to meet external standards Ensure DHF content completion...
. Support design test and inspection method development, and lead method validation activities. Ensure DHF content integrity...
PURPOSE AND SCOPE: Participate in the New Product Development (NPI) and design changes, Design History File (DHF..., and design review. Provides input to design and manufacturing engineering project DHF deliverables including material...
with high complexity and scope. Experience in risk management processes (e.g., CAPAs, DHF remediation, requirements...
complaint Design history Files (DHF) for each project Managing all aspects of assigned projects to ensure timely completion...
PURPOSE AND SCOPE: Participate in the New Product Development (NPI) and design changes, Design History File (DHF..., and design review. Provides input to design and manufacturing engineering project DHF deliverables including material...
(DHF) to ensure compliance with regulatory standards and internal quality requirements. This role is essential for guiding... with regulatory standards. Ensure that all DHF documentation is up-to-date and reflects the current design and development status...