Sr. Manufacturing Engineer - Integra LifeSciences
Cincinnati, OH
About the Job
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.
Sr. Manufacturing Engineer will be responsible to provide technical and engineering support to the Operations department. Responsibilities include: project management, equipment and process improvement projects, supporting the introduction of new processes or equipment into the manufacturing facility, facility equipment, maintenance, calibration, and troubleshooting of equipment, leading investigational activities around non-conformances, operator training and operating procedure/batch record development, creating and developing CAD drawings. Acts as the subject matter expert (SME) for assigned product lines which includes supporting audit activities and first response for shop floor alerts.
ESSENTIAL DUTIES AND RESPONSIBILITIES
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Other duties may be assigned.
+ Designs and works with other engineering personnel to create and develop engineering prototypes of new products/processes.
+ Executes tactical implementation of strategic plans.
+ Prepares cost and time estimates for engineering and project schedules.
+ Instructs engineers and technical support staff on engineering test and build requirements.
+ Supervises and prepares laboratory technician tasks and projects as required.
+ Works as a team leader (and as a team member when required) in the development of engineering designs and tests.
+ Writes engineering test protocols for testing of component parts and integrated systems.
+ Develops and writes specifications for components/systems, product, processes and packaging/labeling.
+ Authors various type of qualification protocols and reports (IQ/OQ/PQ) and White Papers.
+ Works with engineering personnel on production problems and changes as necessary.
+ Works with RA/QA and Documentation departments to establish proper regulatory and quality documentation procedures.
+ Works with Marketing and cross-functional teams to define and introduce new products.
+ Works directly with finish goods suppliers in all aspects of product/process development, release and sustaining activities.
DESIRED MINIMUM QUALIFICATIONS
The requirements listed below are representative of the knowledge, skill and/or ability required for this position.
Education & Experience:
+ BS degree in Mechanical Engineering or Equivalent discipline with at least eight (8) years of related engineering experience; or MS in relevant discipline with at least five (5) years of related engineering experience.
+ Ability to effectively solve complex problems and ability to influence and communicate across all functional groups and levels.
+ Excellent verbal and written communication skills.
+ Medical device experience is desired.
+ Proficiency with development tools (e.g. SolidWorks, autocad) used by the department.
+ Knowledge of Engineering Change Order System.
+ Knowledge of engineering test protocols.
+ Knowledge of company reporting structure.
+ Skills in personal computer spreadsheet, word processor and engineering tools.
+ Ability to carry out engineering calculations and analysis.
+ Ability to lead teams through complex projects.
+ Ability to write engineering documents, test protocols, laboratory notebook entries and reports.
+ Ability to perform component engineering design and changes.
+ Knowledge of GMPs, ISO 13485 Design Control, and Manufacturing Process IQ, OQ, PQ qualifications as related to medical devices is required.
+ Ability to make presentations at company meetings.
+ Ability to communicate effectively with internal and external personnel.
+ Ability to provide departmental technical leadership.
+ Ability to review and analyze engineering reports.
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.
Integra - Employer Branding from Integra LifeSciences on Vimeo (https://player.vimeo.com/video/265760526)
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.
Sr. Manufacturing Engineer will be responsible to provide technical and engineering support to the Operations department. Responsibilities include: project management, equipment and process improvement projects, supporting the introduction of new processes or equipment into the manufacturing facility, facility equipment, maintenance, calibration, and troubleshooting of equipment, leading investigational activities around non-conformances, operator training and operating procedure/batch record development, creating and developing CAD drawings. Acts as the subject matter expert (SME) for assigned product lines which includes supporting audit activities and first response for shop floor alerts.
ESSENTIAL DUTIES AND RESPONSIBILITIES
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Other duties may be assigned.
+ Designs and works with other engineering personnel to create and develop engineering prototypes of new products/processes.
+ Executes tactical implementation of strategic plans.
+ Prepares cost and time estimates for engineering and project schedules.
+ Instructs engineers and technical support staff on engineering test and build requirements.
+ Supervises and prepares laboratory technician tasks and projects as required.
+ Works as a team leader (and as a team member when required) in the development of engineering designs and tests.
+ Writes engineering test protocols for testing of component parts and integrated systems.
+ Develops and writes specifications for components/systems, product, processes and packaging/labeling.
+ Authors various type of qualification protocols and reports (IQ/OQ/PQ) and White Papers.
+ Works with engineering personnel on production problems and changes as necessary.
+ Works with RA/QA and Documentation departments to establish proper regulatory and quality documentation procedures.
+ Works with Marketing and cross-functional teams to define and introduce new products.
+ Works directly with finish goods suppliers in all aspects of product/process development, release and sustaining activities.
DESIRED MINIMUM QUALIFICATIONS
The requirements listed below are representative of the knowledge, skill and/or ability required for this position.
Education & Experience:
+ BS degree in Mechanical Engineering or Equivalent discipline with at least eight (8) years of related engineering experience; or MS in relevant discipline with at least five (5) years of related engineering experience.
+ Ability to effectively solve complex problems and ability to influence and communicate across all functional groups and levels.
+ Excellent verbal and written communication skills.
+ Medical device experience is desired.
+ Proficiency with development tools (e.g. SolidWorks, autocad) used by the department.
+ Knowledge of Engineering Change Order System.
+ Knowledge of engineering test protocols.
+ Knowledge of company reporting structure.
+ Skills in personal computer spreadsheet, word processor and engineering tools.
+ Ability to carry out engineering calculations and analysis.
+ Ability to lead teams through complex projects.
+ Ability to write engineering documents, test protocols, laboratory notebook entries and reports.
+ Ability to perform component engineering design and changes.
+ Knowledge of GMPs, ISO 13485 Design Control, and Manufacturing Process IQ, OQ, PQ qualifications as related to medical devices is required.
+ Ability to make presentations at company meetings.
+ Ability to communicate effectively with internal and external personnel.
+ Ability to provide departmental technical leadership.
+ Ability to review and analyze engineering reports.
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.
Integra - Employer Branding from Integra LifeSciences on Vimeo (https://player.vimeo.com/video/265760526)
Source : Integra LifeSciences