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As a key member of the Operations team at BRIOHEALTH SOLUTIONS INC, you will play a crucial role in the successful transition of products from design to manufacturing. Your expertise will be essential in ensuring that new products, modifications, and enhancements are efficiently integrated into production.
Key Responsibilities- Design Transfer:
- Collaborate with R&D, Manufacturing Engineering, and Quality teams to facilitate seamless product transitions.
- Develop and execute comprehensive manufacturing plans that ensure a smooth design transfer from concept to full-scale production.
- Create and refine manufacturing processes, including necessary equipment, tooling, and fixtures, to optimize safety, quality, and productivity.
- Support process validation efforts, including the development and execution of validation protocols.
- Lead the pFMEA process, DFM/DFA, risk assessments, and establish effective process control strategies.
- Process Enhancement:
- Work alongside Manufacturing Engineering and Quality to troubleshoot production challenges and enhance throughput and yield.
- Develop training materials and provide instruction to manufacturing staff on newly established processes.
- Supplier Relations:
- Establish and nurture strong partnerships with suppliers to ensure quality manufacturing, materials, and equipment.
- Cross-Department Collaboration:
- Demonstrate leadership in organizing and motivating cross-functional teams to adopt and integrate new process technologies.
- Engage with various departments, including R&D, Quality, Regulatory, and Manufacturing, to align on their operational needs.
- Additional Duties:
- Take on extra responsibilities as assigned by management or senior engineering personnel.
- Identify technical risks and resource challenges, proposing effective solutions while fostering trust within the organization.
- Contribute to the development of intellectual property.
- Bachelor's degree in Manufacturing, Mechanical, Electrical Engineering, or a related engineering field.
- 1-4 years of experience in product or process development.
- Experience in the medical device, pharmaceutical, or biotechnology sectors is highly desirable.
- Familiarity with FDA/ISO regulated environments is preferred.
- Knowledge of quality compliance methodologies such as DFM, DOE, and SPC is advantageous.
- Strong communication and interpersonal skills are essential.
- Proficiency in design software, particularly SolidWorks, and Microsoft Office 365 applications.
- Excellent organizational skills and meticulous attention to detail.