Integra LifeSciences Corporation
Location
Columbia, MD | United States
Job description
Integra LifeSciences, a world leader in medical technology, is dedicated to limiting uncertainty for surgeons, so they can concentrate on providing the best patient care. Integra offers innovative solutions in orthopedic extremity surgery, neurosurgery, reconstructive and general surgery, and regenerative wound care.
Founded in 1989 Integra is headquartered in Plainsboro, New Jersey and has more than 4,000 employees worldwide. Integra’s common stock is listed on The NASDAQ Stock Market under the symbol “IART.”
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.
SUMMARY
Reporting to the Columbia Plant Manager, this position is responsible for managing a team of engineers who provide technical support for on-going plant manufacturing operations in the tissue tech Skin product and Medical Product areas. 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 ILS manufacturing operations and the ILS Quality System.
SUPERVISION RECEIVED
Under direct supervision of the Columbia Plant Manager.
SUPERVISION EXERCISED
Direct Reports: Manufacturing / Facilities / Maintenance Engineers (3-8).
DISCRETION & LATITUDE
Discretion to develop project plans, assemble teams, and strategies to enable timely and effective completion of assigned projects.
ESSENTIAL DUTIES AND RESPONSIBILITIES
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Manage a manufacturing engineering team (3-8 Engineers) 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.
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).
Manage and facility maintenance/updates, layout changes and cleanroom functions that impact production.
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.
Develop skills and competencies of the Engineering team.
DESIRED MINIMUM QUALIFICATIONS
Education
BS (MS preferred) in Mechanical Engineering, Pharmaceutical Engineering, Chemical Engineering, or equivalent.
Type and Number Years of Experience
Minimum of 8-10 years' experience in the medical device or pharmaceutical 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.
PMP a plus
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.
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 [email protected] or call us at 855-936-2666.
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