Manager of Design Assurance
Kore1
Valencia
hace 5 horas

KORE1, a nationwide provider of staffing and recruiting solutions, has an immediate opening for Manager of Design Assurance.

What you'll do :

The Manager of Design Assurance is responsible for compliance to procedures and regulations for Design Control of Implant and Externals Products.

In cross functional collaboration, the manager assess new projects for scope, business impact, budget, regulatory strategy, resource allocation, timeline, and project risks and assigns appropriate team resources.

The manager is responsible for the mentoring and deployment of DA resources to ensure successful project execution in compliance with all company and regulatory requirement and in alignment with company priorities.

  • Cooperates with other Management functions in formulating and establishing company policies and operating procedures
  • Oversee DA activities in regards to the development of both new product and product improvements from initial concept, product development, verification planning & testing to product implementation.
  • Partnering with the engineering Project Manager on the Product Lifecycle process, priorities and resource planning, and successful execution of individual product programs.
  • Monitoring new program requirements and assigning personnel to support.

  • Partnering with the global cross functional teams and subject matter experts (reliability engineering, research & development, manufacturing engineering, product sustainability, planning, process sustaining) using program management skills and methodology to capture and organize decision making and content
  • Developing and directing schedules identifying and mitigating project risks and management of critical path and ensuring communication and visibility.
  • Facilitating and advocating DFM knowhow from development subject matter experts into projects and programs.
  • Manage a portfolio of complex initiatives that span one or multiple lines of business
  • Provide on-site leadership for project teams by building and motivating team members to meet project goals, adhering to their responsibilities and project milestones
  • Manage all Design Assurance aspects of multiple related projects to ensure the overall program is aligned to and directly supports the achievement of strategic objectives (schedule, budget, quality, resources)
  • Work creatively and analytically in a problem-solving environment demonstrating teamwork, innovation and excellence
  • Provide status reporting regarding project milestones, deliverable, dependencies, risks and issues, communicating across executive level and teams
  • Provide expertise to the design team on the implementation of international standards (ISO 14971, IEC 60601-1, ISO 13485, particular standards, etc.
  • as they relate to company products.

  • Responsible for the implementation and maintenance of an ISO 14971 compliant risk management process.
  • Creates processes and improvements to ensure consistent implementation of internal requirements and external regulations and standards.
  • Represent the design assurance team for the review and approval of designated design outputs.
  • As needed, participate in the investigations and analysis of product changes and CAPA's.
  • Prepare documentation for and support regulatory submissions (USA, EU, International)
  • Educate different departments on compliance of medical devices per international standards
  • Travelling Requirement Approx. 10%

    What you bring to the team :

    Basic Education

    B.S. in Engineering, Physics, or related applied or physical sciences

    Graduate degree with research in Engineering, Physics, or related applied or physical sciences

    Further Education

    Design for Manufacturability

    Work Experience

  • Minimum of 8 years of professional experience in product development and / or design assurance
  • Min. of 5 years managing technical professions
  • 3+ years of experience working with business stakeholders within a cross-functional matrix environment
  • Class III Medical Device Experience
  • Experience with full product lifecycle with understanding of development lifecycle and various technology methodologies that support that lifecycle
  • Desirable industry background includes medical device, electromechanical systems or small consumer electronics
  • Social Competencies

  • Proven ability to work in an ambiguous environment and collaborate across multiple areas in order to achieve a common business objective
  • Interpersonal skills to influence and spur change, facilitate and enhance performance within a cross - functional environment
  • Leadership Competencies

  • Strong leadership, diplomatic and motivational skills including the ability to lead up, across and down the business
  • Professional Competencies

  • Strong knowledge of relevant regulations and guidance related to design assurance
  • Proven ability to demonstrate drive for results and accountability of business needs
  • Broad technical skills; conversant in Mechanical, Electrical, Biomedical and Systems Engineering, Materials Science, Biology or Neurophysiology, and Statistics
  • Strong experience in and ability to mentor design and execution of experiments
  • Strong analytical skills, attention to detail and logic
  • Proven ability to work creatively and analytically in a problem-solving environment demonstrating teamwork, innovation and excellence
  • Self-motivated, decisive, with the ability to adapt to change and competing demands
  • Flexible with proven ability to conform to shifting priorities, demands and timelines through analytical and problem-solving capabilities
  • Demonstrated communication skills (both written and oral with technical and non-technical staff)
  • Experience representing the DA function in external audits
  • Familiar with FTA, FMEA, HALT, etc.
  • Experience with risk management methodology
  • IT skills

    Proficient in Microsoft Office suite, Minitab or equivalent statistical software and Solidworks CAD or equivalent

    Experience using Agile PLM

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