Senior Manufacturing Engineer
Our Senior Manufacturing Engineer will play a key role in the development of the manufacturing processes for a high volume OTC medicinal product. This will include process development, equipment sourcing, design and support and vendor management. In addition this person will support the development of product requirements, test requirements, qualification and validation of molding tools, process equipment and test equipment. This position will support and cultivate the relationship with part vendors, manual and automation equipment suppliers and contract manufacturing organizations and act as the liaison between the Design Engineering team and the equipment design contractors and/or contract manufacturing organizations.
We are looking for a person who has great attention to detail while working in a fast paced start-up organization. This individual should have the capability of working easily with personnel from all disciplines within the company including Quality, Design Engineering, Drug Delivery, Regulatory and Project Management. They must be a hands-on team player who enjoys building product and pieces of equipment in order to meet aggressive timelines.
- Develop new and existing manufacturing processes independently and with internal and external stakeholders to maximize production capacity and efficiency
- Assist with the design and selection of tooling and production equipment for successful execution of the Manufacturing Strategy
- Write or review manufacturing instructions, requirements documents, qualification protocols, validation reports, drawings, bills of materials and functional and design specifications
- Estimate the production costs, scheduling, capacity and resources required for new and existing products to formulate recommendations to management
- Define manufacturing problems, collect data, establish facts, draw conclusions and establish action plans for timely resolution of issues utilizing root cause analysis techniques
- B.S. degree in Manufacturing Engineering, Mechanical Engineer, Bioengineering, Industrial Engineering or equivalent
- 7+ years of in manufacturing engineering and/or process development, including 3+ years of medical product manufacturing under design controls
- Working in a start-up environment developing processes for unique first generation products
- Directing domestic and international manufacturing suppliers of injection molded parts, electronic services and pharmaceuticals
- Medical device assembly, web converting processes and drug filling applications
- Experience with SolidWorks CAD program and product lifecycle systems
- Application of cost saving techniques in a manufacturing environment such as Six Sigma, Lean, 5S, Kaizen tools
- Thorough knowledge of process development, characterization, qualification and validation
- FDA CFR 210, 211 and 820 as well as ISO 13485
- Able to work independently with minimal supervision and able to manage their project deliverables
- Scale-up of manufacturing processes from manual development line to fully automated commercial capability
- Quality systems for manufacturing, such as Non-Conformances, Engineering Change Orders, CAPA and Deviation processes
- Ability to travel about 25% of the time, both domestic and international
Interested in the Senior Manufacturing Engineer role? Please submit the following application form.