Manufacturing Engineer

Support creation of detailed timelines for new product introductions and follow-through on project tasks through launch completion.

• Develop and execute Master Validation Plans and Validation Protocols/Batch Records for new/existing product lines
• 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.
• 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.
• Ensuring business continuity by providing support and prompt investigation and resolution of process performance drifts and CAPAs
• Assist with various special ad hoc projects and other duties as assigned.

• B.S. in Chemical Engineering, Mechanical Engineering, Industrial Engineering or Biomedical Engineering plus 3-5 years of experience in an Engineering role

• Ability to execute project deliverables to a schedule.
• Ability to work within a team environment and build relationships outside of the department (R&D, Quality, Manufacturing, Regulatory, etc.)
• Ability to listen and clearly communicate verbally, in writing and in person to people at various levels of the organization.
• Experience with common problem-solving skills, including issue resolution, root cause investigations and CAPAs.
• Proficient in Microsoft Word, Excel, PowerPoint.

• Experience with Minitab, Solid Works, and Microsoft Project is a plus.

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 job duties, the employee is occasionally required to stand, walk, sit, use hands to handle or feel objects, tools, or controls, reach with hands and arms, climb stairs, and talk or hear. The employee must occasionally lift or move office products and supplies up to 50 pounds.