Staff Engineer, R&D – Biosurgery
Location:
Somerville , New Jersey
Posted:
April 02, 2017
Reference:
1091170301-en-us

Ethicon, a member of Johnson & Johnson's Family of Companies, is currently recruiting for a Staff Engineer, R&D – Biosurgery to be located in Somerville, NJ.
 
Ethicon, Inc. develops and markets products within the Medical Device business sector of Johnson & Johnson and includes wound closure, biosurgical, energy, and endomechanical products. 
 
The Staff Engineer, R&D – Biosurgery will:
  • Lead the R&D work-stream on life cycle management (LCM)/base-business projects, representing the Ethicon Biosurgery Design Center on a portfolio of design and process change projects.
  • Own Design History Files for LCM project Design and Process Changes
  • Own Design Requirements Matrices for LCM project Design and Process Changes
  • Lead testing on competitive products, and develop strategies on competitive testing, prepare technical reports for use in marketing assets by commercial teams
  • Participate in cross-functional project teams in a technical leadership role to drive the development of product requirements, concept generation, process identification, process scale-up and design control for hemostasis, tissue sealant, and adhesion prevention products
  • Contribute inventions, new designs, or techniques to solve technical problems or improve existing products or processes.
  • Work with in-house teams, cross J&J teams, and external collaborators including companies, universities and consultants to align project strategies with the regulatory, preclinical, and clinical strategies for innovative products to meet business objectives

Qualifications
  • A minimum of a MS in Chemical Engineering, Chemistry (organic, analytical, or polymer), Biomaterials or Biomedical Engineering, or other relevant field with mimimum 10 years of experience in product discovery and development is required. A PhD in Chemical Engineering, Chemistry, Organic Chemistry, Biomaterials Engineering, or other relevant field with minimum 6 years of experience in product discovery and development is preferred.
  • Experience executing Design Changes and Process changes is required
  • Quality systems and Design Control knowledge pertaining to new product development, and Design Changes in the medical devices field is required
  • Hands on experience in manufacturing process development and process validation/qualification is preferred.
  • Hands on experience with innovative research strategies, product development to meet customer unmet needs, and effective requirements management preferred
  • cGMP knowledge are preferred
  • Good technical writing, and communication and project management skills and ability to work Independently are essential
  • Intellectual properties is preferred.
  • Proficiency with design/process excellence tools is preferred.
  • Experience within a matrix organization is preferred.
  • Experience with synthetic polymers at lab-scale through manufacturing-scale is preferred.
  • Knowledge with preclinical research and 510(k), IDE, and PMA processes is preferred.
  • Domestic and international travel up to 10% is required for this position.

Primary Location
United States-New Jersey-Somerville
Organization
Ethicon Inc. (6045)
Job Function
R&D Engineering (R&D)
Requisition ID
1091170301

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