RTI Surgical®
Process Engineering Manager
RTI Surgical®, West Lafayette, Indiana, United States, 47907
While this is intended to accurately reflect the current job, it is not necessarily an exhaustive list of all responsibilities, skills, duties, requirements, or working conditions associated with the job. RTI Surgical, Inc., reserves the right to revise the job or require that other or different tasks are performed when circumstances warrant (i.e., emergencies, changes in personnel or staffing, workload, or technical developments).
COMPANY SUMMARY:
RTI Surgical (RTI) is a global industry-leading contract development and manufacturing organization (CDMO) in regenerative medicine. As the only regenerative medicine company that offers a differentiated portfolio of allograft and xenograft biomaterials at scale, RTI provides customers across a diverse set of market segments with leading-edge expertise, scale, and flexibility across end-to-end services including design, development, regulatory support, verification and validation, manufacturing, and supply chain management. RTI is headquartered in Alachua, FL, and has manufacturing facilities in West Lafayette, Indiana; Eden Prairie, Minnesota; Glencoe, Minnesota and Neunkirchen, Germany.
RTI is rooted in a steadfast commitment to quality, integrity, and patient safety with a focus on five key values:• Accountable: We own our actions and decisions.• Agile: We embrace change to stay ahead of the curve and evolve to drive innovation and growth.• Growth Mindset: We embrace challenges as opportunities for continuous learning.• Customer-Centric: We prioritize customers at every touch point.• Inclusive: We thrive on the richness of our diversity and ensure every voice is heard, respected, and celebrated.
At RTI Surgical, we are committed to fostering an inclusive workplace where we embrace the richness of our diversity and ensure that every voice is heard, respected, and celebrated. We believe that by embracing diversity and promoting inclusivity, we not only uphold our values but also strengthen our position as the CDMO of Choice in regenerative medicine solutions. We recognize that cultivating a growth mindset is essential to our success, and we are dedicated to continuous learning and improvement in our diversity, equity, and inclusion efforts. Through accountability and action, we strive to create an environment where individuals can thrive, innovate, and contribute their unique perspectives to drive our collective success.
Montagu Private Equity ("Montagu"), a leading European private equity firm, acquired RTI in 2020 and has supported the transformation of the company to its next level of potential.
Primary Function
The person in this position is responsible for providing leadership to the Process Engineering team and process engineering projects to support operations and product quality. This position is responsible for coordinating resources necessary to drive completion of work.
Personnel
Provide direction to team members about daily tasks and long-term goals related to company strategy and project completion.Support process engineering efforts, as resourced by Process Engineering. Such support will include hiring, training, motivating, evaluating, and scheduling.Collaborate to set process engineering priorities based on company needs.Provide personnel support for the following activities: CIE projects, process risk analysis, NCMR response, deviation response, NC investigations, ETI event response, completion of ECPs, and regulatory support.Conduct performance appraisals and wage reviews for direct reports.Processes
Manage the process of completing process engineering projects.Establish metrics to measure performance and output of process engineering work.Provide input on and help drive continuous improvement of key process engineering responsibilities including project management, risk analysis, process validation, and process development.Review and pre-approve change requests.Participate in change control committee (CCC) meetings.Participate in process risk analysis meetings (RCG and RCCC).Maintain the master validation plan (MVP) and master PFMECA index (MPI) and ensure completion of required periodic updates.Ensure timely completion of process validation review reports.Communication
Ensure direct reports are well-informed about company information, events, processes, and priorities.Work with other CBI leaders to ensure proper communication channels exist between process engineering and other areas.Understand available data related to CBI manufacturing and use the information to drive conversations about project prioritiesOther
Remain current and apply the understanding of FDA-ISO 13485 and Quality System Requirements in carrying out duties.Administer and ensure compliance to the Cook Biotech and OSHA/IOSHA requirements for Hazard CommunicationConduct other corporate duties when required.Minimum Work Experience/Educational Requirements
Excellent written and verbal communication skillsProven ability to lead and manage projectsProven ability to communicate and work constructively with colleagues to establish and achieve mutual goalsSufficient background to generally understand process validation processesBachelor's degree in engineering with extensive work experience in process validationAt least four years industry experience in medical device manufacturing and process validationAt least four years of previous management experience.Willing to work with material derived from animal tissuesPhysical Requirements/Work Environment
Must be able to perform the essential functions of the job, with or without reasonable accommodationsLimited exposure to hazardous chemicals used in the manufacture of the product.Physical demands are typical of an office and classroom environment.
COMPANY SUMMARY:
RTI Surgical (RTI) is a global industry-leading contract development and manufacturing organization (CDMO) in regenerative medicine. As the only regenerative medicine company that offers a differentiated portfolio of allograft and xenograft biomaterials at scale, RTI provides customers across a diverse set of market segments with leading-edge expertise, scale, and flexibility across end-to-end services including design, development, regulatory support, verification and validation, manufacturing, and supply chain management. RTI is headquartered in Alachua, FL, and has manufacturing facilities in West Lafayette, Indiana; Eden Prairie, Minnesota; Glencoe, Minnesota and Neunkirchen, Germany.
RTI is rooted in a steadfast commitment to quality, integrity, and patient safety with a focus on five key values:• Accountable: We own our actions and decisions.• Agile: We embrace change to stay ahead of the curve and evolve to drive innovation and growth.• Growth Mindset: We embrace challenges as opportunities for continuous learning.• Customer-Centric: We prioritize customers at every touch point.• Inclusive: We thrive on the richness of our diversity and ensure every voice is heard, respected, and celebrated.
At RTI Surgical, we are committed to fostering an inclusive workplace where we embrace the richness of our diversity and ensure that every voice is heard, respected, and celebrated. We believe that by embracing diversity and promoting inclusivity, we not only uphold our values but also strengthen our position as the CDMO of Choice in regenerative medicine solutions. We recognize that cultivating a growth mindset is essential to our success, and we are dedicated to continuous learning and improvement in our diversity, equity, and inclusion efforts. Through accountability and action, we strive to create an environment where individuals can thrive, innovate, and contribute their unique perspectives to drive our collective success.
Montagu Private Equity ("Montagu"), a leading European private equity firm, acquired RTI in 2020 and has supported the transformation of the company to its next level of potential.
Primary Function
The person in this position is responsible for providing leadership to the Process Engineering team and process engineering projects to support operations and product quality. This position is responsible for coordinating resources necessary to drive completion of work.
Personnel
Provide direction to team members about daily tasks and long-term goals related to company strategy and project completion.Support process engineering efforts, as resourced by Process Engineering. Such support will include hiring, training, motivating, evaluating, and scheduling.Collaborate to set process engineering priorities based on company needs.Provide personnel support for the following activities: CIE projects, process risk analysis, NCMR response, deviation response, NC investigations, ETI event response, completion of ECPs, and regulatory support.Conduct performance appraisals and wage reviews for direct reports.Processes
Manage the process of completing process engineering projects.Establish metrics to measure performance and output of process engineering work.Provide input on and help drive continuous improvement of key process engineering responsibilities including project management, risk analysis, process validation, and process development.Review and pre-approve change requests.Participate in change control committee (CCC) meetings.Participate in process risk analysis meetings (RCG and RCCC).Maintain the master validation plan (MVP) and master PFMECA index (MPI) and ensure completion of required periodic updates.Ensure timely completion of process validation review reports.Communication
Ensure direct reports are well-informed about company information, events, processes, and priorities.Work with other CBI leaders to ensure proper communication channels exist between process engineering and other areas.Understand available data related to CBI manufacturing and use the information to drive conversations about project prioritiesOther
Remain current and apply the understanding of FDA-ISO 13485 and Quality System Requirements in carrying out duties.Administer and ensure compliance to the Cook Biotech and OSHA/IOSHA requirements for Hazard CommunicationConduct other corporate duties when required.Minimum Work Experience/Educational Requirements
Excellent written and verbal communication skillsProven ability to lead and manage projectsProven ability to communicate and work constructively with colleagues to establish and achieve mutual goalsSufficient background to generally understand process validation processesBachelor's degree in engineering with extensive work experience in process validationAt least four years industry experience in medical device manufacturing and process validationAt least four years of previous management experience.Willing to work with material derived from animal tissuesPhysical Requirements/Work Environment
Must be able to perform the essential functions of the job, with or without reasonable accommodationsLimited exposure to hazardous chemicals used in the manufacture of the product.Physical demands are typical of an office and classroom environment.