Product Development Engineer IV
Pharmacyclics
HerediaCR
hace 4 días

About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow.

We strive to have a remarkable impact on people’s lives across several key therapeutic areas : immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio.

For more information about AbbVie, please visit us at www.abbvie.com. Follow abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

JOB SUMMARY :

Lead / Collaborate / Execute product and process development projects (NPI and MPS) from the R&D function.

Develop, collaborate and evaluate new materials, new products / processes or modifications to existing products / processes, as well as analysis and measurement methods, from Design Validation and Verification (DVV) to Process Validation, including the design manufacturability through the development phases (GPF).

KEY DUTIES AND RESPONSIBILITIES :

  • Perform the local and / or global role of Product Development in the Global Breast team (Global Core Team) for MPS (Marketed Product Support) and / or NPI (New Product Introductions) projects.
  • Lead / Collaborate processes / product development for NPI (New Product Introductions) or MPS (Marketed Product Support) projects, as part of the Development Sub-Team.

    It is considered a key member of the Design Team.

  • Lead / Support pre-concept and other research efforts for plastics franchise, including but not limited to product, process and test methods development.
  • Collaborate with the other engineering functions on site for transformation projects, providing technical knowledge to find solutions for each need.
  • Support / lead technical efforts or projects related to product design, especially when they are linked to regulatory agencies responsibilities, or to submit special requirements for a new or existing product. 10%
  • All other functions inherent to the position such as supporting change control, audits, CAPAs, complaint investigations, Regulatory and Marketing inquiries and related testing or data generation, and other tasks as assigned by the immediate superior.
  • JOB QUALIFICATIONS :

  • Bachelors or higher degree in Science or Engineering such as Industrial Engineering, Material Engineering, Chemical Engineering, Chemistry or related degree.
  • Minimum 7 years of experience in the medical device industry required; or equivalent combination of
  • training and experience are required.
  • Advanced degree desired but not required.
  • Fluent English Speaker (Advance >
  • 90%)

  • Knowledge Quality Management Systems / Regulations (GMP, QSR, FDA, CAPA, ISO)
  • Microsoft Office, Minitab desirable, Solidworks or AutoCAD desirable.
  • Medical device experience required; design control development process knowledge is preferred.
  • Knowledge of plastics / rubber parts / silicone design and processing methods preferred.
  • Knowledge of materials design, materials testing, and related physical / chemical characterizations of material properties is preferred.
  • Technical writing skills.
  • Risk Management knowledge including FMEA, desirable.
  • Knowledge on equipment qualifications and process validations.
  • Understanding of the principles of Design for Manufacturability and testability is preferred.
  • Ability to function in a controlled environment regulated by FDA GMPs and handle confidential data required.
  • Job Level Code

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