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Principal Engineer, Design Assurance in Marlborough, MA at Angiodynamics, Inc.

Date Posted: 6/28/2018

Job Snapshot

Job Description

The Principal Design Assurance Engineer is a core member of multidisciplinary new product development and design change teams. Responsible for quality assurance elements within the product development and design change process. Plan and direct activities concerned with the design, development, application, implementation and maintenance of quality standards to ensure that all new and existing products meet their requirements for safety and effectiveness. Key activities include assuring that product design conforms to user/applicable standards, assuring that product design minimizes risk, and assuring product design is adequately/tested/evaluated. Provide support during design and development process as well as evaluation of product or process change and post-market surveillance information. Act as a contributor to company quality policies including maintenance and updates of SOP's, Work Instructions and employee training regimes. Participate in mentorship of lower level design assurance engineers within the organization.

Essential Duties and Responsibilities

  • Enhanced fundamental understanding of quality philosophies, principles, methods, tools, standards, organizational and team dynamics, interpersonal relationships, professional ethics, and legal and regulatory requirements.
  • Provides Supervisory Responsibilities to design assurance personnel (as necessary).
  • Provides project direction, coaching, and mentoring to design assurance personnel.
  • Leads or supports the implementation of design controls designed to meet internal and external requirements.
  • Acts as an effective leader or team member in supporting design assurance disciplines, decisions and practices.
  • Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  • Assists with the establishment of customer focused specifications to ensure they adequately address clinical, engineering, regulatory, and marketing requirements.
  • Assures compliance of design control system and product specifications with applicable EN/ISO standards, FDA,QSR, European MDD, and applicable international requirements.
  • Leads product risk management activities according to ISO14971 (including creation of Risk Management Plan, Hazard Analysis, Failure Modes Analysis, and Risk Management Report)
  • Design verification and validation strategy development and review and approval of validation and verification plans and testing activities in compliance with relevant standards, including simulated use testing and clinical evaluation.
  • Participates in periodic design reviews during the development process to assure compliance with design requirements.
  • Analyzing and understanding test data, including statistical analysis and providing statistical support where necessary.
  • Reviews proposed product and process changes to assess their effect on design requirements and to ensure the adequacy of the supporting testing.
  • Coordinates failure investigations and root cause analysis for product complaints and other post market surveillance product performance information as necessary.
  • Reviews and actively ensures policies and SOP's are followed.
  • Supports internal/external audits and reviews as necessary.
  • May perform other duties as assigned
  • Software Requirements (Applicable to Principal DA Engineer for software experience)
    • Assures compliance of software development and maintenance processes to reduce the risks associated with various software development methodologies.
    • Consults with product development to evaluate system interfaces, operational requirements, and performance requirements of overall system.
    • Defines test methods and creates test plans for new or updated software projects to determine if the software will perform accurately and reliably according to documented requirements as well as established standards under both normal and abnormal conditions.
    • Supports configuration management processes, including planning, configuration identification, configuration control, change management, and reporting.
    • Reviews requirements for traceability and testability.
  • Supervisory Responsibilities

Regulatory Responsibilities

  • Manages in order to ensure compliance with all relevant regulatory/legal requirements

QUALITY SYSTEMS DUTIES AND RESPONSIBILITIES

  • Management - Establish and support a work environment of continuous improvement that supports the Quality Policy, Quality System and the appropriate regulations for the area they support. Ensure all employees are trained to do their work and their training is documented