Senior Design Quality Engineer

1970-01-01Davis Companieshttp://daviscos.com/wp-content/themes/davis_theme/assets/images/logo.svg325 Donald J. Lynch Boulevard, Suite 201MarlboroughMA01752USAcustomer support[+800-482-9494][+508-481-8519]
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Senior Design Quality Engineer

  • Specialty:

    Engineering
    • City:

      Memphis
    • State:

      TN
    • 38133
  • Assignment Type:

    Direct Hire
  • Job Id:

    50484
  • Payrate:

    $40.87

Description

Senior Design Quality Engineer

The Senior Design Quality Engineer’s primary focus is to work with Product Development from the initial design concept to design transfer and release to commercialization. The Design Quality Engineer will actively participate in all phases of design review, risk management reviews, and approve all testing to support design verification and validation activities.  During design reviews provide input for design, gauging, as well as design for manufacturability.  Review designs for sterility and provide feedback for incorporating devices into the sterilization validations.   Ensure that all documentation will support worldwide regulatory submissions.          

RESPONSIBILITIES: 

  • Actively participate in design reviews and give feedback on design inputs and outputs.  Ensuring that the designs comply with the regulations for all targeted markets.
  • Works with Product Development on design Verification and Validation activities.
  • Reviews and approves all Product Development Design Testing protocols and technical reports.
  • Works closely with Regulatory Affairs to ensure that Technical Documentation conforms to appropriate standards, such as 21 CFR, FDA harmonized, ISO, IEC, EN ISO, 10993-X, for 510k submissions, Technical Files and ROW.  
  • Ensure that the appropriate biological testing was conducted for the type of device or that a biological risk assessment has been conducted.
  • Actively participates in risk management activities such as DFMEAs or PFMEAs.  Ensuring the consistent application of risks are made across similar product lines.
  • Participates in the final review and release of new devices into inventory.  Will make the final decision for release.
  • Works closely with the Sterilization Group and reviews new designs for adoption into the current sterilization validations.  Will work with Sterilization group for products that will require new sterilization validation.
  • Works with Product Development and Materials Management for new supplier selection and approval.  Documents Supplier risk assessments to ensure that the supplier will be able to provide a safe and effective device.
  • Works with Product Development to identify device critical features and Control Plans for new products.       

.REQUIREMENTS:

  • Bachelor of Science degree in engineering or related engineering field.
  • Minimum of Five (5) years of quality, regulatory or product development experience in medical devices.
  • Minimum of Two (2) years hands on experience performing risk assessments to ISO 14971. 
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
  • Strong organizational and follow up skills, as well as attention to detail.
  • Ability to travel approximately 5%.
  • Strong back ground in quality and regulatory compliance. 

REQUIRES A THOROUGH KNOWLEDGE OF:

  • The Food and Drug Administration’s CFR 21 Part 820;
  • Risk Management systems such as ISO 14971 Risk Management – Application of Risk Management to Medical Devices;
  • International Quality System Regulations such as:
  1. ISO 13485,
  2.  Medical Device Directive 93/42/EEC

Quick Apply

  • As an Equal Employment Opportunity Employer, DAVIS has reporting requirements which require us to invite employees to voluntarily self-identify their race/ethnicity. Submission of this information is voluntary and refusal to provided it will not subject you to any adverse treatment. The information obtained will be kept confidential.
  • Accepted file types: pdf, doc, docx, txt, rtf.
  • By applying to this position and providing my contact information, I give The DAVIS Companies permission to provide me with email communications and information.

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