Validation Engineer II

ID# DCCA26709

dinaliC is an international consulting firm specialized in projects for numerous industries. We are dedicated to provide contract and permanent opportunities for skilled professionals in their area or areas of expertise

JOB OVERVIEW 

SUMMARY OF THE JOB

Participate in Quality System software development teams automated equipment projects, and other activities to develop software products, verification and validation tests, and quality processes to ensure compliance with company Quality System policies, procedures, standards (FDA, MDD 93/42, ISO 13485, ISO 14971, ISO 62304 ) and other worldwide regulatory agencies, and  applicable standards as pertains to medical devices.  Provide software quality expertise and guidance.   

  • Experience with the Software Development Life Cycle, (SDLC) including multiple product / application releases from an SQE perspective.
  • Contribute to and help improve SQE processes and practices to maximize the department's productivity. 
  • Demonstrated ability to work on multiple projects simultaneously and to resolve scheduling and other conflicts in order to meet all deadlines
  • Will be considered a subject matter expert (SME) on quality improvement tools and will work on complex problems and projects.  
  • Will show leadership in driving program/projects and be resourceful; creative in developing approaches and solutions to problems and shares technical expertise with others mentor a diverse array of employees at all levels of the organization.

ESSENTIAL DUTIES AND RESPONSIBILITIES

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The listed requirements are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Primary responsibilities include working with other functional groups in support of software  development projects, and defining the software quality and compliance standards 
  • Develop and establish effective quality control and associated risk management plans for software projects.
  • Experience with the Software Development Life Cycle, (SDLC) including multiple product / application releases from an SQE perspective.
  • Extensive experience in software quality assurance, including the development and implementation of validation protocols/reports, standards, white-box/ black-box testing, integration testing, automation, and quality metrics
  • Write, review and/or approve Engineering Change Control requests  relating to software.
  • Review and comment on software project plans, test plans, etc. to ensure they satisfy applicable requirements.
  • Ensure that development activities follow design control requirements, software systems and software products are tested per applicable standards, FDA / European Essential Requirements and other regulatory and non-regulatory agencies are met. 
  • Participate and investigate Corrective and Preventative Actions (CAPA) as appropriate.
  • Perform audits of internal software development projects and evaluate software development and installation activities of external providers.
  • Work to develop new or improved standard operating procedures and work instructions.
  • Assesses the feasibility and soundness of proposed engineering evaluation tests, products or equipment when necessary data are insufficient or confirmation by testing is advisable.
  • Performs other duties assigned as needed

REQUIRED EDUCATION/TRAINING and/or EXPERIENCE: 

BS in Computer Science, Computer or Software Engineering, Electrical Engineering or a related engineering discipline is required. A minimum of 5 years of quality, manufacturing, or research and development experience in a medical device or other regulated industry is required.  . 

KNOWLEDGE, SKILLS, ABILITIES and CERTIFICATIONS/LICENSES: 

  • American Society for Quality (ASQ) certification, Six Sigma experience, and/or knowledge of Process Excellence tools is desirable - Preferred
  • Ability to define problems, collect and analyze data, establish facts and draw conclusions and recommendations - Required
  • Ability to use broad knowledge of regulatory, technical, and business requirements to conduct due diligence assessments-Required
  • Ability to apply project management skills to ensure fulfillment of development requirements-Require
  • Ability to develop and implement Quality standards-Required
  • Knowledge of Quality and operations systems and processes, including GMP and QSR requirements for medical devices-Required
  • Knowledge of leading edge Quality Engineering, design control, and verification and validation (V&V) tools and methodologies-Preferred
  • Understanding of Six Sigma and Process Excellence tools and methodologies.  Lean manufacturing experience desirable-Preferred
  • Ability to effectively communicate with internal and external personnel at all levels of the organization-Required

ADDITIONAL POSITION REQUIREMENTS

  • Competent using MS Office (word, excel, power point, outlook, etc)
  • Ability to multi-task and manage multiple assignments in a time manner
  • Strong verbal, written, and interpersonal communication skills; the ability to write technical reports and convey in-depth technical topics to others
  • Strong interpersonal and leadership skills

RESPONSIBILITY FOR OTHERS (If applicable)

  • May technically guide, coordinate and review the work of junior engineers and technicians; estimate manpower needs and schedules and assign work to meet completion date.

 

 

Position Details:

Medical Device

Engineering

Start Date: 
9-30-2013
End Date: 
12-31-2013

IRWINDALE, CA

CON_W2

40

DCCA26709

No

No