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SUMMARY

This position reports to the Plant Manager and is responsible for manufacturing engineering at the Integra Tissue Technologies Plant located in South Boston and the build out of our new manufacturing facility in Braintree. This position is responsible for managing a team of engineers who provide technical support for on-going plant manufacturing operations. This position is responsible for leading projects to evaluate, analyze, and improve existing processes, implement statistical process controls, analyze and trend existing process parameters, improve manufacturing yields, reduce scrap, conduct non-conformance investigations, and execute CAPA project work which supports manufacturing operations and the Quality System.

ESSENTIAL DUTIES AND RESPONSIBILITIES

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

• Manage a manufacturing engineering team to support process scale-up for current manufacturing operations and the build out of our new manufacturing facility in Braintree, MA. These projects are typically of increased complexity and can pose significant risk to product and processes if not designed and implemented correctly.

• 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 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.

• Oversee 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).

• 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.

• 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.

• Conduct performance reviews and other HR procedures and duties for departmental staff in accordance with company policy.

• Oversee and direct all performance management, training, development, job descriptions, and safety procedures for all direct reports.

MINIMUM QUALIFICATIONS

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

• Bachelor degree or equivalent with 8+ years of experience or master degree with 5+ years of experience, degree in engineering or similar related field

• Experience in the medical device, pharmaceutical or similarly highly regulated industry with experience in process development and/or process engineering.

• 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.

• Experience managing direct reports.

• 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.

• Six Sigma LEAN a plus.

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.

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