What are the responsibilities and job description for the Integration Engineer II position at Regenity Biosciences?
Position Summary/ Objectives
The Integration Engineer II/Sr. Integration Engineer will be responsible for supporting the engineering and development activities of new and existing products. The ideal candidate has a solid understanding of manufacturing processes and can support the strategic and operational objectives of the business. The successful candidate will possess a high degree of professionalism, maturity, and confidentiality.
Essential Job Functions
Utilize understanding of Design Control Procedures to support new product launches from initial concept to launch completion, including laboratory activities for prototyping and testing, creation of technical documents and specifications, and transfer of processes to manufacturing.
Prepare detailed timelines for new product introductions and launches and follow through on project tasks through launch completion.
Develop Maste Validation Plans and Validation Protocols/Batch Records for new/existing product lines, as needed, capturing process, packaging, sterilization validation requirements.
Work independently or in support of other engineers/scientists in troubleshooting technical issues encountered during prototyping, scale-up and manufacturing of products.
Prepare Bills of Materials for new product lines and processes, working collaboratively with various groups (production, quality control, ERP) to develop cost of goods estimates.
Develop and implement validation protocols as needed
Write or revise batch records and standard operating procedures to support new product introductions
Work closely with cross-functional teams and make data driven decisions to move projects forward that align with business goals.
Perform other related duties and responsibilities as assigned or required, including scale-up and/or process optimization of existing products.
Assist with various special ad hoc projects and other duties as assigned.
Initiate, recommend, or provide solutions through designated channels.
Competencies
Meaningful Innovation
Ownership/Accountability
Pace/Efficiency
Teamwork/Collaboration
Integrity/Ethical Practice
Resilience/Grit
Physical Demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is occasionally required to stand; walk; sit; use hands to finger, handle, or feel objects, tools or controls; reach with hands and arms; climb stairs; talk or hear. The employee must occasionally lift or move office products and supplies, up to 50 pounds.
Education, Experience And Certification
B.S. in Biomedical Engineering, Material Science, Chemical Engineering, or other branch of science which includes Collagen Science plus 3-7 years of experience in an Engineering role (Job level will be determined by experience)
Good understanding of Collagen and/or Tissue science preferred
Ability to work within a team environment and build relationships outside of the department (R&D, Quality, Manufacturing, Regulatory, etc.)
Exceptional personal organization skills. Ability to prioritize tasks in a high energy fast-paced environment working with minimal supervision.
Ability to listen and clearly communicate verbally, in writing and in person to people at various levels of the organization.
Exceptional problem-solving skills and proven track record of success.
Proven ability to manage projects to a schedule is desirable.
Proficient in Microsoft Word, Excel, PowerPoint.
Experience with Minitab and Microsoft Projects.
Experience with SolidWorks is a plus.
Other Duties As Required
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
The Integration Engineer II/Sr. Integration Engineer will be responsible for supporting the engineering and development activities of new and existing products. The ideal candidate has a solid understanding of manufacturing processes and can support the strategic and operational objectives of the business. The successful candidate will possess a high degree of professionalism, maturity, and confidentiality.
Essential Job Functions
Utilize understanding of Design Control Procedures to support new product launches from initial concept to launch completion, including laboratory activities for prototyping and testing, creation of technical documents and specifications, and transfer of processes to manufacturing.
Prepare detailed timelines for new product introductions and launches and follow through on project tasks through launch completion.
Develop Maste Validation Plans and Validation Protocols/Batch Records for new/existing product lines, as needed, capturing process, packaging, sterilization validation requirements.
Work independently or in support of other engineers/scientists in troubleshooting technical issues encountered during prototyping, scale-up and manufacturing of products.
Prepare Bills of Materials for new product lines and processes, working collaboratively with various groups (production, quality control, ERP) to develop cost of goods estimates.
Develop and implement validation protocols as needed
Write or revise batch records and standard operating procedures to support new product introductions
Work closely with cross-functional teams and make data driven decisions to move projects forward that align with business goals.
Perform other related duties and responsibilities as assigned or required, including scale-up and/or process optimization of existing products.
Assist with various special ad hoc projects and other duties as assigned.
Initiate, recommend, or provide solutions through designated channels.
Competencies
Meaningful Innovation
Ownership/Accountability
Pace/Efficiency
Teamwork/Collaboration
Integrity/Ethical Practice
Resilience/Grit
Physical Demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is occasionally required to stand; walk; sit; use hands to finger, handle, or feel objects, tools or controls; reach with hands and arms; climb stairs; talk or hear. The employee must occasionally lift or move office products and supplies, up to 50 pounds.
Education, Experience And Certification
B.S. in Biomedical Engineering, Material Science, Chemical Engineering, or other branch of science which includes Collagen Science plus 3-7 years of experience in an Engineering role (Job level will be determined by experience)
Good understanding of Collagen and/or Tissue science preferred
Ability to work within a team environment and build relationships outside of the department (R&D, Quality, Manufacturing, Regulatory, etc.)
Exceptional personal organization skills. Ability to prioritize tasks in a high energy fast-paced environment working with minimal supervision.
Ability to listen and clearly communicate verbally, in writing and in person to people at various levels of the organization.
Exceptional problem-solving skills and proven track record of success.
Proven ability to manage projects to a schedule is desirable.
Proficient in Microsoft Word, Excel, PowerPoint.
Experience with Minitab and Microsoft Projects.
Experience with SolidWorks is a plus.
Other Duties As Required
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
