Director, Manufacturing Engineering - Integra LifeSciences
Plainsboro, NJ
About the Job
Changing lives. Building Careers.
Joining us is a chance 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, our colleagues are challenging what's possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.
SUMMARY
The Director, Engineering is a key member of the plant leadership team responsible for providing leadership to the factory engineering department, assuring full compliance with company and regulatory requirements. Drives engineering strategies and recommends operational plans that directly impact business results. Provides expertise on complex technical issues with in-depth subject matter knowledge. Directs the execution of Sustaining Engineering, Project Engineering, and Continuous Improvement teams. Oversees manufacturing process non-conformance investigations, root cause analysis and successful corrective actions. Champions effective project management execution through structured problem-solving strategies and methodologies. Accountable for change management and continuous improvement efforts across all value streams.
ESSENTIAL DUTIES AND RESPONSIBILITIES
* Oversees, directs and manages plant engineering and continuous improvement teams through managers and senior professionals.
* Accountable for long range capital planning (LRP CAPEX) of the site technology roadmap
* Leads special technical programs including new product introduction (NPI), major process transfers and new technology implementation.
* Drives effective root cause analysis, structured problem solving, and timely effective corrective and preventive actions for manufacturing non-conformances.
* Accountable for engineering resource deployment planning and visibility aligned with enterprise objectives.
* Oversees the Life Cycle Management (LCM) program to minimize product supply disruption. Serves as main point of contact to key stakeholders and cross functional teams for collaboration and visibility.
* Ensure critical manufacturing processes and equipment business continuity risks are identified and addressed with mitigation actions.
* Drives and directs implementation of strategic continuous improvement roadmap.
* Provides direction and guidance for validations, transfers, and process engineering activities. Facilitates cross functional knowledge transfer to ensure smooth transitions.
* Strong collaboration with peer plant leadership team members to resolve issues and solve problems.
* Champion employee talent development through active management coaching.
* Evaluates performance on a timely basis and recommends personnel actions, such as promotions, transfer, discharge or disciplinary actions. Responsibilities include interviewing, hiring, and training employees: planning, assigning, and directing work; appraising performance; addresses complaints and resolving problems.
* Manage other duties as assigned.
DESIRED MINIMUM QUALIFICATIONS
The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.
* Bachelor's Degree in Engineering, Science or other relevant field.
* 10+ years professional experience is preferred in a medical device or pharmaceutical manufacturing environment including five years in a management position.
* Demonstrated organizational and communication skills. Must possess strong leadership skills with team-focused attitude. Strong interpersonal and communication skills.
* Demonstrated knowledge of FDA regulations and other National and International regulations and standards.
* Demonstrated computer skills.
* Strong background in continuous improvement and problem solving.
* Solid strategic thinking skills to drive continuous improvement
INTEGRA LEADERSHIP CAPABILITIES
As a senior leadership position in the company, the role is expected to demonstrate on all Integra Leadership Capabilities.
* Enterprise Mindset: Leaders with this capability make decisions, set priorities, and share resources based on what will benefit Integra as a whole.
* Thought Leadership: Leaders with this capability build personal credibility and utilize business acumen and customer mindset to influence the innovation and growth of the business.
* Drive Performance: Leaders with this capability drive performance and accountability through others and self.
* Enable Talent: Leaders with this capability strive to engage, support, and develop self and others, optimizing the success of individuals and teams.
TOOLS AND EQUIPMENT USED
Computers, specialized software for complaint reporting, general office equipment including, printers, copiers, scanners, and fax machines.
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 write/type. The employee is required to go to all areas of the company. Must be able to independently travel via car or airplane to domestic and international locations as needed.
DISCLAIMER
The duties listed above are intended only as illustrations of the various types of work that may be performed. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or a logical assignment to the position.
The job description does not constitute an employment agreement between the employer and employee and is subject to change by the employer as the needs of the employer and requirements of the job change.
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 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, our colleagues are challenging what's possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.
SUMMARY
The Director, Engineering is a key member of the plant leadership team responsible for providing leadership to the factory engineering department, assuring full compliance with company and regulatory requirements. Drives engineering strategies and recommends operational plans that directly impact business results. Provides expertise on complex technical issues with in-depth subject matter knowledge. Directs the execution of Sustaining Engineering, Project Engineering, and Continuous Improvement teams. Oversees manufacturing process non-conformance investigations, root cause analysis and successful corrective actions. Champions effective project management execution through structured problem-solving strategies and methodologies. Accountable for change management and continuous improvement efforts across all value streams.
ESSENTIAL DUTIES AND RESPONSIBILITIES
* Oversees, directs and manages plant engineering and continuous improvement teams through managers and senior professionals.
* Accountable for long range capital planning (LRP CAPEX) of the site technology roadmap
* Leads special technical programs including new product introduction (NPI), major process transfers and new technology implementation.
* Drives effective root cause analysis, structured problem solving, and timely effective corrective and preventive actions for manufacturing non-conformances.
* Accountable for engineering resource deployment planning and visibility aligned with enterprise objectives.
* Oversees the Life Cycle Management (LCM) program to minimize product supply disruption. Serves as main point of contact to key stakeholders and cross functional teams for collaboration and visibility.
* Ensure critical manufacturing processes and equipment business continuity risks are identified and addressed with mitigation actions.
* Drives and directs implementation of strategic continuous improvement roadmap.
* Provides direction and guidance for validations, transfers, and process engineering activities. Facilitates cross functional knowledge transfer to ensure smooth transitions.
* Strong collaboration with peer plant leadership team members to resolve issues and solve problems.
* Champion employee talent development through active management coaching.
* Evaluates performance on a timely basis and recommends personnel actions, such as promotions, transfer, discharge or disciplinary actions. Responsibilities include interviewing, hiring, and training employees: planning, assigning, and directing work; appraising performance; addresses complaints and resolving problems.
* Manage other duties as assigned.
DESIRED MINIMUM QUALIFICATIONS
The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.
* Bachelor's Degree in Engineering, Science or other relevant field.
* 10+ years professional experience is preferred in a medical device or pharmaceutical manufacturing environment including five years in a management position.
* Demonstrated organizational and communication skills. Must possess strong leadership skills with team-focused attitude. Strong interpersonal and communication skills.
* Demonstrated knowledge of FDA regulations and other National and International regulations and standards.
* Demonstrated computer skills.
* Strong background in continuous improvement and problem solving.
* Solid strategic thinking skills to drive continuous improvement
INTEGRA LEADERSHIP CAPABILITIES
As a senior leadership position in the company, the role is expected to demonstrate on all Integra Leadership Capabilities.
* Enterprise Mindset: Leaders with this capability make decisions, set priorities, and share resources based on what will benefit Integra as a whole.
* Thought Leadership: Leaders with this capability build personal credibility and utilize business acumen and customer mindset to influence the innovation and growth of the business.
* Drive Performance: Leaders with this capability drive performance and accountability through others and self.
* Enable Talent: Leaders with this capability strive to engage, support, and develop self and others, optimizing the success of individuals and teams.
TOOLS AND EQUIPMENT USED
Computers, specialized software for complaint reporting, general office equipment including, printers, copiers, scanners, and fax machines.
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 write/type. The employee is required to go to all areas of the company. Must be able to independently travel via car or airplane to domestic and international locations as needed.
DISCLAIMER
The duties listed above are intended only as illustrations of the various types of work that may be performed. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or a logical assignment to the position.
The job description does not constitute an employment agreement between the employer and employee and is subject to change by the employer as the needs of the employer and requirements of the job change.
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