Changing lives. Building Careers.

Joining us is a chance for you 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, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes.

ESSENTIAL DUTIES AND RESPONSIBILITIES

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

Primary responsibilities are to:

• Manage a manufacturing engineering team to lead and execute projects to support manufacturing operations. These projects are typically of increased complexity and can pose significant risk to product and processes if not designed and implemented correctly.

• Develop skills and competencies of the Manufacturing Engineering team.

• Manage engineers on the team on engineering activities and projects as listed below.

• Initiate, develop and implement Engineering Studies and 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 Requests/Orders (ECR/ECO) and Engineering Drawings.

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

• Project Management aimed to evaluate, analyze, and improve existing processes, support the transfer of manufacturing processes, and manufacturing process troubleshooting. Must be able to manage projects in their entirety, and also be able to perform/deliver specific project tasks as necessary. Effectively implement problem solving skills and techniques to identify potential issues, assess their impact and develop and implement mitigation and resolution plans and activities.

• As required, conduct Non-Conformance Investigations, assist or lead in the prompt implementation of Non-Conformance resolution, and Corrective and Preventive Action(s) (CAPA).

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

• Execute other work as assigned by management

SUPERVISION RECEIVED

Under direct supervision of the Manager, Manufacturing Engineering

SUPERVISION EXERCISED

Direct Reports: Manufacturing Engineers (5-8)

DISCRETION & LATITUDE

Discretion to develop project plans, assemble teams, and strategies to enable timely and effective completion of assigned projects.

DESIRED MINIMUM QUALIFICATIONS

The requirements listed below are representative of the knowledge, skill and/or ability required for his position.

Education: BS (MS preferred) in Biomedical Engineering, Chemical Engineering, or equivalent.

Type and Number Years of Experience

• Bachelors degree or equivalent with 3+ years of experience leading a team, Masters degree with 0-2 years of experience leading a team

• Minimum of 3 years experience in process development, engineering, and/or project management, preferably in medical device or pharmaceutical industry.

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

• 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, Excel, 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 the position.

While undertaking the essential duties and responsibilities of the position, the employee must repeatedly sit, listen, speak and have the ability to move throughout all locations of the building. The employee is required to go to all areas of the facility. 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 wastes.

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 and 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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