Head of Manufacturing Engineering & NPI

at  Vital Bio

About you: In this Technical Leadership role, you will establish and lead the development and technology transfer of consumable manufacturing and assembly processes at Vital. This will include the design, fabrication, development, installation, and qualification of equipment for building consumable assemblies under cGMP controls, Technology transfer from Consumable Engineering and Assay Process Development, Make/Buy recommendations, and transfer to third-party vendors as appropriate. Duties include providing guidance and direction to technical manufacturing engineering staff, creating, reviewing, and approving validation protocols/reports, developing annual budgets and project plans, identifying, justifying, and supporting installation and maintenance of critical manufacturing equipment as well as scaling production operations of consumables to support the Assay development and engineering teams as part of the product development. What you’ll do: Provide technical leadership for the Manufacturing Process Development team, including mentoring and developing staff members; Ensure that projects are appropriately defined, planned, and staffed with personnel and resources; Coordinate with other cross-functional leaders to plan and execute strategies and plans to effectively complete product development and design transfer activities; Lead work to maintain, support, and improve the performance and reliability of Vital products and their manufacturing processes; Manage communication of requirements, scope, and hand-offs for various transfer activities; Define timelines and milestones for manufacturing process development activities in support of the overall development schedule, including process development, process characterization, process qualification, and process validation; Lead the manufacturing process development and production teams in the identification of technical and schedule risks, identify and implement effective countermeasures to reduce the probability and impact; Establish appropriate manufacturing processes and controls to create and maintain consistency and quality of production from prototype through production scale-up; Identify space and equipment requirements and capital requirements along with justification for production and work with executive leadership and other functional leaders to develop appropriate plans and timelines for implementation; Responsible for documentation review to ensure compliance with regulatory and compliance requirements; Provide oversight into investigations of CAPA related to manufactured products and manufacturing processes; Provide day-to-day leadership, clear direction, guidance, and performance feedback to the manufacturing engineering team; Other related duties as required.
What you need: Bachelor’s Degree in a relevant field; 10+ years of industry experience in introducing new products and processes into manufacturing, with specialized knowledge and experience in cGMP manufacturing in the IVD space; Demonstrated ability to plan and execute tech transfer, process development, and scale-up of new technologies and processes effectively for combination products for Diagnostics; Familiar with global IVD regulations related to the manufacture of instruments, reagents, and consumables for IVDs, validation/qualification requirements, and recordkeeping; Excellent communication skills and attention to detail; Strong organizational skills and ability to multitask across projects and activities; Proven ability to build effective teams and participate in multi-disciplinary teams. What you’ll get: An opportunity to shape the future of medical diagnostics and make a meaningful impact on global healthcare; A collaborative environment with a high-performing team dedicated to innovation and excellence; Competitive compensation and benefits package; A platform to showcase your talents and grow professionally in a company that values your contributions. What excites us: Experience with lean and Six Sigma methodologies and their application during product development, design transfer, and production scale-up; Prior experience with high-volume consumable assembly and automation would be welcomed; An appreciation of puns

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