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Reporting to the Director of Process Engineering, this position is responsible for functional and people management of engineers and/or technicians as well as support of manufacturing process development, characterization, and implementation associated with Manufacturing Operations and New Product Introductions. This position is responsible for ensuring that manufacturing process development and characterization activities associated with existing process improvements and new process development activities are robust.

SUPERVISION RECEIVED

This position reports to the Director of Process Engineering and is expected to drive projects independently with little supervision required.

SUPERVISION EXERCISED

This position includes direct reports.

ESSENTIAL DUTIES AND RESPONSIBILITIES

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

• Establish, plan and execute strategic objectives for process development in coordination with divisional and plant management.

• Provide technical leadership in the development and mentoring of the Process Engineering team to ensure that sound and disciplined experimental strategies, methodologies, and plans are in place when developing and characterizing existing or new manufacturing processes.

• Lead process engineering related activities to support existing product site transfers and new product commercialization.

• Ensure manufacturing processes remain in state of control by coordinating with plant management on process monitoring and improvement, supporting CAPAs, and reviewing process change requests.

• Guide engineers and technicians in performing hands-on laboratory work for prototyping and to optimize and scale-up processes to full-scale manufacturing. Development of specifications for new processes.

• Drive improvements in the Process Engineering Group through the wide implementation and use of six sigma methodologies in the characterization, development, and improvement of manufacturing processes to ensure robustness.

• Lead and manage efforts to create novel processes, leading to full scale manufacturing of Integra Regenerative products.

• Work as part of a cross-functional team (Manufacturing, QA/QC/RA, Engineering, Facilities, Materials Management, Finance, Marketing) to scale up and transfer implantable collagen-based products/processes from R&D to full-scale manufacturing, following Design Control Procedures.

• Interface and partner with Product Development and Operations to ensure alignment on process improvement, development, and characterization activities.

• Lead, support, and participate on special operations improvement projects as needed.

• Manage site process engineering budget

• Work independently with vendors/suppliers to develop new equipment and establish raw material specifications for new and/or improved processes.

• Apply experience with manufacturing process equipment to lead the selection and/or design of equipment from prototype and full-scale manufacturing.

• Generate technical documents/reports (engineering studies, validation, URS, FAT, production SOPs, drawings).

DESIRED MINIMUM QUALIFICATIONS

The requirements listed below are representative of the knowledge, skill, and/or ability required.

Education

• BS/MS in Bioengineering, Mechanical Engineering, Pharmaceutical Engineering, Chemical Engineering, Materials Science, or equivalent.

• Use of statistical process tools highly desired: Minitab, Six Sigma, Lean are a plus

Experience

• 10+ years of experience in medical device or pharmaceutical environment.

• 7+ years of direct experience in the development, characterization, and improvement of manufacturing processes working with cross-functional teams with Quality System Regulation (QSR), GMP, Design Control, and Process Validation guidelines applied to the Medical Device industry.

• High proficiency with validation fundamentals (IQ/OQ/PQ), statistics, and process capability (CpK, sampling methodologies, etc).

• Experience in clean rooms, lyophilization or biomaterials.

• General chemistry, processing and materials expertise.

• Exceptional problem solving, organizational, and communication skills.

• Practical product fabrication.

• Use of statistical process tools highly desirable, Minitab a plus.

TOOLS AND EQUIPMENT USED

• The individual will be fully versed in the use or Microsoft Office software and tools (Outlook, Project, Powerpoint, Word, & Excel) and use of statistical tools. Use of standard analytical equipment and devices, and small to medium scale prototyping equipment.

TRAVEL

• Periodic travel to Integra manufacturing sites, suppliers and conferences is required.