Principal Process Engineer, Biosurgery R&D

Ethicon, Inc. a member of the Johnson & Johnson Family of Companies is currently recruiting for a Principal Process Engineer, Biosurgery R&D located in Somerville, NJ.
The Global Surgery Group is comprised of the following businesses within Johnson & Johnson: Ethicon Surgical Care, Ethicon Energy, Ethicon Biosurgery, Acclarent, Biosense Webster, Advanced Sterilization Products, Mentor and Sterilmed. With annual sales of $11 billion, the Global Surgery Group is the world's largest, most innovative surgical company. The strength of the Global Surgery Group is illustrated by the fact that more than 80% of our sales come from businesses with #1 or #2 global market share positions. We serve customers around the world, with about 60% of our sales generated outside the U.S., including a fast-growing presence in emerging markets. The Global Surgery Group is committed to innovation, with about 30% of our sales coming from products introduced in the past five years.
Ethicon Biosurgery is a leading provider of proven solutions to address a range of bleeding and leaking situations ‚€“ from routine to problematic -- during surgical procedures. These solutions can be used for open and minimally invasive procedures across broad range of specialties: cardiothoracic, cardiovascular, vascular, spine, neuro, GYN, urology, othropedic, ENT, bariatric, plastic and general surgery. Our product portfolio includes proprietary oxidized regenerated cellulose hemostats; gelatin powder and sponges; a flowable hemostatic matrix; human thrombin, and fibrin sealant. Additionally, Ethicon Biosurgery encompasses the Biopatch¬ line of business, an evidence-based dressing choice for local infections, catheter-related bloodstream infections (CRBSI) and skin colonization of microorganisms commonly related to CRBSI in patients with central venous or arterial catheters. Ethicon Biosurgery is a division of Ethicon, Inc., a trusted leader in surgical care and part of the Johnson & Johnson Family of Companies. The company has been in operation for more than 50 years and is headquartered in Somerville, New Jersey.
The Principal Process Engineer, Biosurgery R&D:
Will participate in Ethicon-Biosurgery new product development projects, developing manufacturing processes related to advanced hemostats and sealants.
Will lead the R&D work-stream responsible for process development from the front-end prototype generation stage, through end-to-end pilot-scale and commercial scale.
Will identify manufacturing process options, lead the team through the manufacturing process selection and lead the product-process characterization efforts
Must plan, design and execute studies utilizing statistically-based (e.g., DFSS and DMAIC) and DFMA approaches to achieve optimum outcomes.
Must be able to work in a project-focused organization, and are expected to partner with the Operations, Quality and Regulatory Affairs departments during all phases of process development.
Must ensure the work is conducted in accordance with current cGMP requirements. Maintain compliance with all appropriate SOPs for laboratory work and data recording. Use and maintain laboratory equipment in accordance with established SOPs.
Must comply with safety guidelines including maintaining up to date training and proper documentation of lab notebooks and logbooks.
Must apply intensive and diversified knowledge of engineering principles and practices in broad areas of assignments and related fields, make decisions independently on process engineering problems and methodologies.
A minimum of a Bachelor's degree in Polymer Science and Engineering, Chemical Engineering, Material Science or a related discipline with a minimum of 10 years of previous related industry experience is required, OR a Master's Degree in a similar field with a minimum of 7 years related experience OR a PhD in a similar field with a minimum of 5 years related experience is required.
Must have demonstrated experience in taking polymer synthesis from lab-scale through to manufacturing scale.
Must have an in-depth understanding of quality systems and design control.
Design/Process Excellence proficiency as it relates to medical devices is required. Six Sigma black-belt certification is a plus.
Experience in manufacturing equipment design and selection is preferred.
Good technical writing skills, including intellectual property, communication and project management skills, and ability to work independently are required.
This position is based in Somerville, NJ and may require up to 10% travel, both domestic and international.

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