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.

The Manufacturing Engineer I will play a key role in the support of manufacturing operations, process scale–up, and manufacturing improvement activities. They will oversee projects to evaluate, analyze, and improve existing processes, support the development of new manufacturing processes, implement statistical process controls, analyze and trend existing process parameters, improve manufacturing yields, reduce scrap, and error proof manufacturing processes.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Process engineering and project management to support process scale-up and current manufacturing operations. These projects are typically of increased complexity and can pose significant risk to product and processes if not designed and implemented correctly. Complete projects aimed to evaluate, analyze, and improve existing processes, support the development of new manufacturing processes, and manufacturing process troubleshooting. Must be able to perform/deliver specific project tasks as necessary

Ensure that all appropriate documentation, drawings, and specifications are generated in compliance with Integra’s procedures and statutory requirements (US FDA and ISO).

Initiate, develop and implement IQ/OQ/PQ validations for equipment and processes to meet the demands of new product introductions and current manufacturing operations. Coordinate specific efforts as required by the project team. Includes such tasks as development of manufacturing process requirements, specifications, validations, Engineering Change Orders (ECO) and Engineering Drawings.

Support projects to implement statistical process control (as necessary), analyze and trend existing process parameters, process inputs and outputs, improve manufacturing yields, reduce manufacturing scrap, and error proof manufacturing processes.

Perform timely technical investigations and provide practical manufacturing solutions, under appropriate regulatory guidelines for Medical Device Manufacture. As required, conduct Non-Conformance Investigations, assist or lead in the prompt implementation of Non-Conformance resolution, and Corrective and Preventive Action(s) (CAPA support).

Participate and collaborate in technical teams for identified projects and products, which may include personnel from Engineering, Manufacturing, Product Development, Marketing, QA, and Clinical & Regulatory Affairs.

Effectively implement problem solving skills and techniques to identify potential issues, assess their impact and develop and implement mitigation and resolution plans and activities.

Provide plant input in manufacturing process development, to include but not limited to, process design requirements, risk analysis, traceability matrix, design history file, etc.

Provide daily analytical and technical support to meet manufacturing objectives. Provide technical input for analysis of process and equipment changes.

Apply experience with manufacturing process equipment to lead the selection and/or design of equipment for prototype and full-scale manufacturing. Evaluate and upgrade process equipment as required.

Execute other work as assigned by management

DESIRED MINIMUM QUALIFICATIONS

Bachelor's degree in Engineering (Mechanical Engineering, Pharmaceutical Engineering, Chemical Engineering, Biomedical Engineering) or equivalent experience.

0-2 years of experience in manufacturing engineering within the medical device industry.

Experience with Quality System Regulation (QSR), Design Control and Process Validation guidelines, Engineering Change Controls, ISO, Design Control and Regulatory guidelines are required. Experience with biomaterials, in cleanrooms, and Lyophilization a plus.

Experience with Statistical Process Control tools required (SPC, Minitab, other software).

General chemistry, processing, and material expertise.

Considerable knowledge of the principles and practices of engineering as applied to various types of projects.

Ability to prepare complex technical reports, project summaries, and correspondence.

Exceptional practical problem-solving skills, excellent organizational and communication skills.

TOOLS AND EQUIPMENT USED

Computers, standard analytical equipment and devices, and small to medium-scale prototyping equipment. Expert in the use of Microsoft Office software and tools (Outlook, Project, PowerPoint, Word) and use of statistical tools.

PHYSICAL REQUIREMENTS

The physical requirements listed in this section include, but are not limited, to the motor/physical abilities and skills require 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 this position.

While undertaking the essential duties and responsibilities of the position, the employee must repeatedly sit, listen, speak, write/type, view computer screens and have the ability to move throughout all locations of the building. The employee is required to go to all areas of the company. The employee may be required to periodically lift and/or move up to 25 pounds.

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 bio-hazardous materials that include, but are not limited to, flammable and corrosive liquids, compressed gases, sharps, and medical waste.

SELECTION GUIDELINES

Formal application, rating of education and experience; 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 | EOE including Disability/Protected Veterans

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. 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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