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Manufacturing Engineering Manager
US-NJ-Plainsboro, Vacancy ID2023-44507
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Changing lives. Building careers.
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."
Reporting to the CMC Plant Manager, this position is responsible for managing a team of engineers who provide technical support for on-going plant manufacturing operations in the CMC 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.
Under direct supervision of the CMC Plant Manager.
Direct Reports: Manufacturing / Operations 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.
Primary responsibilities are to:
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).
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.
Develop skills and competencies of the Engineering team.
What are we looking for?
BS (MS preferred) in Mechanical Engineering, Pharmaceutical Engineering, Chemical Engineering, orequivalent.
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.
In an effort to minimize the spread of the coronavirus and to protect our employees, all new hires in the US and Puerto Rico will need to be fully vaccinated for COVID-19 in order to be considered for employment with Integra LifeSciences, unless eligible for an accommodation as provided by law.
We are proud of our 25 year heritage as a leader in regenerative medicine. Today, our scientific innovation and diverse product portfolio continue to help patients and surgeons around the world.
We have an entrepreneurial, small company feel, yet deliver big company results. Your ideas - big and small - are welcome here. We embrace change and reward our people who are committed to making Integra a stronger company.
We believe how we do things is as important as what we do. Our Values guide how we work and how we act towards our customers, patients and each other every day. We value Our People, Integrity, Excellence, Embracing Change, Decisiveness and Teamwork.
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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