Sr. Design Assurance Engineer - Therapy Delivery at Nextern | Torre
Sr. Design Assurance Engineer - Therapy Delivery
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Nextern

Sr. Design Assurance Engineer - Therapy Delivery

Nextern
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Full-time

USD75.4K - 100K/year

~COP150M - 200M/year

+ Equity

+ Bonuses

location_on
Remote (anywhere)
Posted about 3 years ago

Responsibilities

Nextern offers excellent benefits to fuel you in building a fulfilling life & career: Employer subsidized health insurance for employees, Employer paid dental insurance, Employer HSA contribution, 401k plan with a company match, 9 paid holidays (including your birthday!) + PTO and Personal days, Gym membership subsidy, Employee Short Term Disability, Long Term Disability, and AD&D Life Insurance The Sr. Design Assurance Engineer is responsible for supporting design assurance throughout the product lifecycle, specific to the Therapy Delivery business unit. Design Assurance Engineers work with the development, manufacturing, and quality team to ensure devices are designed in accordance with product requirements, ISO 13485, and 21 CFR 820. They develop and maintain risk management plans, sterilization plans, audit against the requirements for the DHF, and provide feedback on product requirements, risk assessments, and verification methods. Responsibilities: - Guides the Design Control process for product development projects. Sets strategies and drives towards compliant and efficient solutions to complex problems. - Responsible for Design Verification and Validation planning & execution. - Leads root-cause investigations and resolution activities. - Reviews, provides feedback, and approves project design and development deliverables as the quality lead. - Leads Risk Management and Usability program activities from product Concept through Commercialization. - Performs risk and impact assessments for design changes to products. - Ensure DHF content integrity, completeness, and regulatory / standards compliance; collaboratively communicating & resolving gaps. - Support design test and inspection method development, and lead method validation activities. - Writes risk management plans, design verification and validation plans, and may author associated reports. - Co-owns, with the project manager, the processes and documentation for design reviews, DHF content structure, and project Design Reviews. - Review and approve development build records.
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