Job Information
Integra LifeSciences Manufacturing Engineer I in Plainsboro, New Jersey
Changing lives. Building Careers.
Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what's possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.
This position is responsible for supporting the design and development of manufacturing equipment and processes and updating systems for new and existing products. Must work with outside equipment suppliers and internal stakeholders to develop equipment requirements and design specifications
ESSENTIAL DUTIES AND RESPONSIBILITIES
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
Responsible for engineering and project execution to support new or existing product transfers to the Integra LifeSciences Facilities within the Tissue Technologies organization.
Collaborate with Product Development, Process Engineering, local Plant Engineering, Quality, and Manufacturing groups to ensure successful execution of projects.
Responsible for supporting project management, process development, process improvement, IQ/OQ//PQ validations, developing and meeting transfer goals and metrics, optimization of the transfer process to ensure that new equipment and processes are delivered in an efficient, timely, and compliant manner with robust manufacturing processes.
Provide daily analytical and technical support to meet department objectives once products are transferred.
Assist in the selection and/or design of equipment for prototype and full-scale manufacturing working with outside suppliers.
Ensure that all appropriate documentation, drawings and specifications are generated in compliance with Integra's procedures and under current change control procedures as required.
Assist in executions of validations, work orders, drawings, and procedures.
DESIRED MINIMUM QUALIFICATIONS
The requirements listed below are representative of the knowledge, skill, and/or ability required.
*BS in Mechanical, Chemical, Electrical Engineering or equivalent combination of education and experience. Scientific degrees will be considered with appropriate work experience.
One to three years of experience in a medical device or regulated industry. Experience in new Process and Equipment development preferred.
Experience in clean room operations, environmental control, and biomaterials a plus.
Exceptional practical problem solving, organizational and communication skills,
Expert Microsoft Office software and tools.
Experience in the application of robotics for manufacturing a plus.
Use of statistical process tools highly desirable. Minitab or Statgraphics a plus.
TOOLS AND EQUIPMENT USED
Microsoft Office software and tools (Outlook, Project, PowerPoint, Word) and use of statistical tools, standard analytical equipment and devices, small to medium scale prototyping equipment. Should be fluent and current with CAD design and modeling (preferably SOLIDWORKS).
PHYSICAL REQUIREMENTS
The physical requirements listed in this section include, but are not limited, to the motor/physical abilities and skills required of this position in order to successfully undertake the essential duties and responsibilities of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to empower individuals with disabilities to undertake the essential duties and responsibilities of the position. While undertaking the essential duties and responsibilities of the position, the employee must repeatedly
sit, listen, and speak. The employee is required to go to all areas of the company including mechanical areas with limited access and ladders. The employee may be required to periodically lift and/or move up to 40lbs.
ADVERSE WORKING CONDITIONS
The adverse working conditions listed in this section include, but are not limited to, those environmental conditions to which the employee may be exposed while undertaking the essential duties and responsibilities of this position, which is that of a general plant environment.
Adverse exposure may result from the handling of hazardous and biohazardous materials that include, but are not limited to, flammable and corrosive liquids, compressed gases, sharps, and medical wastes.
TRAVEL
This position requires occasional domestic and international travel to Integra LifeSciences Facilities and vendors. 25% travel is anticipated with very limited international travel.
SELECTION GUIDELINES
Formal application, rating of education and experience; oral interview and reference check; job related tests may be required.
DISCLAIMER
The duties listed above are intended only as illustrations of the various types of work that may be performed. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or a logical assignment to the position.
The job description does not constitute an employment agreement between the employer and employee and is subject to change by the employer as the needs of the employer and requirements of the job change.
Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.
This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices:
EEO Is the Law (https://www.eeoc.gov/laws/index.cfm) | EOE including Disability/Protected Veterans (https://www.eeoc.gov/eeoc/publications/ada_veterans_employers.cfm)
Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA (https://www.eeoc.gov/eeoc/publications/fs-ada.cfm) . If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com or call us at 855-936-2666.
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