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Senior Manager, Design Assurance

Company: Nevro
Location: Redwood City
Posted on: May 3, 2021

Job Description:

About Nevro

Nevro (NYSE: NVRO) is a global medical device company headquartered in Redwood City, California. We are focused on providing innovative products that improve the quality of life of patients suffering from debilitating chronic pain.We started with a simple mission to help more patients suffering from chronic pain. At each stage of development, our research was subject to the highest levels of scientific rigor, resulting in a new therapy that has impacted the lives of over 70,000 patients around the world.Nevro has developed and commercialized the Senza spinal cord stimulation (SCS) system, an evidence-based, non-pharmacologic neuromodulation platform for the treatment of chronic pain. HF10 therapy has demonstrated the ability to reduce or eliminate opioids in 65% of patients across six peer-reviewed clinical studies. The Senza System, Senza II System, and the Senza Omnia System are the only SCS systems that deliver Nevro's proprietary HF10 therapy.

Job Summary & Responsibilities

Reporting to Sr. Director of Quality Systems, this position is responsible for the management and enhancement of the quality system, collaborating with all departments within the company to ensure compliance to process/procedures related to Design Controls, Usability, Risk Management, and Software Quality. Applies knowledge of QSR and GMP requirements on a daily basis.

Applying knowledge of QSR and GMP requirements on a daily basis, the duties and responsibilities for this position include, but are not limited to, the following:

  • Provide direction to employees and direct reports regarding processes related to Design Controls, Usability, Risk Management, Software Quality
  • Responsible/ championing on execution of quality related projects within the department and across departments
  • Ensure Risk Management and Hazard Analyses strategies are established in cooperation with cross-functional engineering teams per project requirements
  • Support and collaborate with peers and other departments in the implementation of Quality Engineering practices for the effective and efficient development, transfer, and maintenance of products/processes throughout the product lifecycle
  • This role works closely with hardware and software development teams to ensure quality compliant products
  • Provide support and willingness to lead external audits
  • Provide support for maintaining QSR, GLP, GMP and FDA compliance standards and keeping up-to-date on current regulations and industry standards
  • Ensure compliant documentation including Design History Files, Device Master Records, and Device History Records
  • Maintain quality systems requirements through procedures, work instructions and documentation including but not limited to:
  • Design control;
  • Software Quality;
  • Risk Management;
  • Human Factors;

  • Other duties as assigned

Role Requirements

  • Bachelor's degree in science or engineering required; advanced degree preferred
  • Equivalent work experience may be substituted for education requirement

Skills and Knowledge

  • No fewer than Fifteen (15) years of directly related experience, with at least Eight (8) of those years in a class II or III medical device environment;
  • At least Five (5) years of experience managing direct report(s)
  • Direct experience maintaining procedures as they relate to the FDA Quality System regulations part 820 and ISO 13485 required;
  • Understand and working knowledge of IEC 60601-1, IEC 62304, EN ISO 14971, IEC 62366-1, 62366-2, EN 556-1, EN ISO 11135, EN ISO 10993, ASTM D4169, FDA Software Guidance, Management of Cybersecurity or similar standards, Soldering Standards (IPC-A-610)
  • Practical applications of statistical concepts including SPC techniques, hypothesis testing, DOE, and sampling plans;
  • Ability to analyze data, create reports from this analysis, and chart trends;
  • Strong technical capability, verbal and written communications skills and effective interpersonal skills;
  • Strong organizational and presentation skills;
  • ASQ Certification (i.e. CQA/CQE/CQM) is desirable;
  • Ability to identify improvement opportunities and implement changes is required;
  • Ability to multitask, prioritize and meet deadlines;
  • Ability to communicate well with all levels of staff and present data to Management when needed;
  • Ability to thrive in a fast-paced, multidisciplinary environment;
  • Demonstrated experience managing direct reports, including recruiting, developing, coaching, and team building
  • This position may require up to 10% domestic & international travel

#LI-TS1

Keywords: Nevro, Redwood City , Senior Manager, Design Assurance, Other , Redwood City, California

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