Integra LifeSciences Corporation
Location
Cincinnati, OH | 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.
The position will lead the Manufacturing Engineering team including production support, new product and intercompany transfer, equipment qualification, process validation, process efficiency, quality and supply issues resolution and labeling for the Integra Cincinnati manufacturing location.
The Manager will lead and collaborate with contractors and cross-functional groups across the organization to implement initiatives, projects and improvements as necessary.
The Manager will partner with the operations teams to meet customer fulfillment needs as well as lead process optimization, yield improvement, six sigma process excellence and lean projects. They will also partner with product development (R&D), regulatory, and quality teams to develop, qualify, and validate new products and processes to meet business needs.
ESSENTIAL DUTIES AND RESPONSIBILITIES
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
Primary responsibilities are to:
Serve as a member of the site leadership team participating in strategic and tactical planning & execution to ensure site objectives are met. Ensure alignment of engineering objectives with overall site objectives.
Provides strategic leadership for defining and executing the site 5-year vision, engineering vision, objectives, strategies, and metrics (KPI).
SME (subject matter expert) in design control regulations; participate on or lead department resources assigned to product develop or technology transfer project teams.
Deploy Design of Experiment (DOE) methodology to characterize process capability, identify sources of variation, establish statistical process control limits, and point of failure.
SME (subject matter expert) in qualification and validation, including IQ, OQ, PQ, PV, facility, software, and test method qualification.
Collaborate with the site EHS Manager and CI Specialist in LEAN methodologies with applied experience on project teams. Review manufacturing activities and provide recommendations and support to improve safety, reduce cost, improve cycle times and material flows.
Mentor team in both project and program management
Develop continuous improvement & contingency plans for plant equipment and processes to ensure business continuity.
Provide direction, resources, and technical leadership to ensure that manufacturing systems & equipment are maintained in good operating condition. Identify and undertake cost improvement projects.
Promote compliance-based culture. Ensure timely and effective investigation & resolution of engineering non-conformances (NC) & corrective and preventive action (CAPA).
Assess and develop capital plans for production & process equipment replacement and or addition of new equipment.
Deliver and manage department budget.
Plan the development and/or acquisition of required talent though development of skills and capabilities in the appropriate engineering field and leadership. Review capabilities on a frequent basis; highlight and fill key voids.
DESIRED MINIMUM QUALIFICATIONS
Bachelor degree in Mechanical, Industrial, Chemical, Material Science or equivalent with 5+ years of experience leading a team, Master degree with 3+ years of experience leading a team, Doctoral degree with 0-2 years of experience leading a team.
Experience in the medical device industry preferred.
5+ years direct employee management experience
Machining and material finishing experience desirable.
Lean & Six Sigma certification highly desirable.
Knowledge of FDA CFR, ISO, QSR, and change controls regulations and procedures.
Demonstrates excellent organizational and communication skills (oral and written).
Positive leadership, sound interpersonal, and employee development skills required.
Project/program management, process improvement and reliability experience.
Ability to handle pressure and directing/managing a fast-paced environment.
Must have demonstrated knowledge in computers and business software (MS office, MS project).
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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