Senior Design Quality/Design Assurance Engineer



Company Name:

Mainstay Medical

Job Location:

2159 India Street

Suite 200

San Diego, CA 92101

Position Title:

Senior Design Quality/Design Assurance Engineer

Position Type:

Full time

General Job Description


Mainstay Medical is seeking a driven and passionate Senior Design Quality/Design Assurance Engineer. This individual will actively participate in product development teams. Performs quality/reliability engineering activities to ensure that the design/development procedures, design controls, supplier controls and test requirements are fulfilled. Leads Risk Management (ISO 14971) activities. May lead cross functional teams in planning, analyses (DFMEA, FTA, Risk/Benefit) and mitigations. Maintains risk management file for the lifetime of the device. We hope you will join us on this journey to ReActiv8 life.


Responsibilities:

  • Good understanding of medical device regulation (FDA, EU and international), quality systems requirements (FDA and ISO 13485)

  • Familiarity with IS0 14971 and product stands such as IEC60601, 10993, and other medical device standards.

  • Ability to work independently and with all levels of managers, associates, and teams

  • Leads Risk Management (ISO 14971) activities. May lead cross functional teams in planning, analyses (DFMEA, FTA, Risk/Benefit) and mitigations. Maintains risk management file for the lifetime of the device.

  • Generates and/or reviews related project deliverables such as: design verification and design validation protocol and reports as well as process validation protocols and reports. Coordinates with Production development in the review of technical documentation.

  • Works with Product Development/Manufacturing in the development of test fixtures, develop production acceptance criteria and test methodology.

  • Conducts Independent review of DHF and Technical files, provides technical standards interpretation, and determines appropriate statistical methods, including sample size determination.

  • Provides support in conducting root cause analyses, preparation of CAPA and Product Risk Assessment. Draft and update SOPs as required.

  • Support audits and continuous improvement activities

  • Complete all other related duties assigned.

Qualifications:

  • B.S. degree in Engineering or related fields

  • 3+ years’ experience in Design Assurance, including Quality systems, standards, metrics, and tools. Advanced degrees will substitute for 1 year of experience.

  • Certified Quality Engineer (CQE)

  • Excellent verbal communication and interpersonal skills.

  • Demonstrated excellent organizational skills with attention to detail.

  • Proficient in computer operations, including Microsoft Word, Outlook, Excel PowerPoint, and basic database management.

  • Problem solver and capable to find solutions to challenges.

Application Information & Contact (How to Apply)


Forward your resume to: careers@mainstay-medical.com


Learn more about the company here

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