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
- 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.
United States-New Jersey-SomervilleOrganization
Ethicon Inc. (6045)Job Function
R&D Engineering (R&D)Requisition ID