Staff RD Engineer LCM

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Job Function:

R&D Product Development

Job Sub Function:

Biomedical Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Raritan, New Jersey, United States of America

Job Description:

We are searching for the best talent for a Staff R&D Engineer, Life Cycle Management located in Raritan, NJ.

Purpose: The R&D Staff Engineer will lead the R&D work-stream on life cycle management (LCM)/base-business projects, representing Ethicon Biosurgery R&D on a portfolio of design and process change projects in the field of Hemostats, Sealants and Adhesion Prevention. This individual will work with other R&D scientists, engineers and cross functional partners in creating files to support existing product improvement, and other life cycle management activities, own Design History Files for LCM project Design and Process Changes, own Design Requirements Matrices for LCM project Design and Process Changes to ensure quality and regulatory compliance.

Under general direction and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position will:

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• Lead the R&D work-stream on life cycle management (LCM)/base-business projects, representing Ethicon Biosurgery R&D on a portfolio of design and process change projects in the field of Hemostats and Sealants
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• Own Design History Files for LCM project Design and Process Changes
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• Own Design Requirements Matrices for LCM project Design and Process Changes
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• Lead testing on competitive products, and develop strategies on competitive testing, prepare technical reports for use in marketing assets by commercial teams
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• Lead activities for complaint handling for marketed products
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• 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
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• Contribute inventions, new designs, or techniques to solve technical problems or improve existing products or processes.
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• 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.
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• Responsible for communicating business related issues or opportunities to next management level
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• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
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• For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
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• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
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• Performs other duties assigned as needed
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Education:

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• A minimum of a MS in Chemistry (organic, analytical, or polymer), Materials, Mechanical, Biomaterials or Biomedical Engineering, or other relevant field with 7 years of experience in technical transfer and/or product discovery and development is required.
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• Knowledge of preclinical regulatory requirements for FDA and notified bodies outside the US is preferred.
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Required Skills & Experience:

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• Experience executing Design Changes and Process changes
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• Quality systems and Design Control knowledge pertaining to product development, and Design Changes in the medical devices field
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• Experience with statistical software for study design and data analysis, eg, Minitab, SAS, SAS JMP, SPSS.
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• Good technical writing, including auditable documentation, strong communication skills, project management skills, and ability to work Independently are essential
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Preferred Skills & Experience:

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• Hands on experience in manufacturing process development and process validation/qualification
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• Hands on experience with innovative research strategies, product development to meet customer unmet needs, and effective requirements management
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• Process Excellence, or the like, and cGMP knowledge
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• Experience in PLM system, e.g. Adaptiv
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• Proficiency with design/process excellence tools
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• Experience within a matrix organization
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• Experience with lab-scale through manufacturing-scale
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• Knowledge with preclinical research and medical device regulations (510(k), IDE, and PMA processes)
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Other:

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• This position is based in Raritan, NJ, and requires up to 10% travel
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The anticipated base pay range for this position is ($124,500) to ($169,000)

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year. Bonuses are awarded at the Company’s discretion on an individual basis.

Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. Additional information can be found through the link below.

Eligible for benefits to include medical, dental, vision and time off as well as any others as provided for in the applicable Collective Bargaining Agreement.

For additional general information on company benefits, please go to: -

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via _ ** **_ . internal employees contact AskGS to be directed to your accommodation resource.