Director, Industrial Launch Leader Careflux
Fresenius Medical Care · Ogden
PURPOSE AND SCOPE:
Supports FMCNA's mission, vision, core values and customer service philosophy. Adheres to the FMCNA Compliance Program, including following all regulatory and division/company policy requirements.
The Director, Careflux Industrial Launch Leader will lead the end-to-end NPI product development cycle from concept, design freeze through manufacturing transfer, qualification, ramp up and ensure reliable, high-yield commercial production. Together with the Product development and Manufacturing and Supply Chain representatives (MSC). The Director owns Design Transfer and industrial Ramp-Up phase, ensuring qualified machinery, supply chain capacity, and trained personnel required to meet volume targets.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
The Director will lead the program to make it a successful launch to market from Industry readiness prospective by working with multiple workstreams as mentioned below.
- Responsible for Design Verification & Validation, and Design Transfer preparation
- Ensure entire product portfolio and all its variants are verified, validated for all dialysis platforms and ecosystems for commercial launch.
- Secure product quality and long-term robustness early by ensuring they are thoroughly verified during formal verification testing phases.
- Drive early, proactive alignment between the Vertical, Manufacturing Supply Chain (MSC), and Supplier Quality Readiness (SQR) to ensure manufacturing requirements and design for manufacturability/assembly considerations are incorporated early enough in product development to minimize industrialization risk prior to the MR2 milestone and confirm product manufacturability prior to the MR3 milestone.
- Establish clear roles and responsibilities across engineering and operations teams throughout the entire design verification and transfer.
- Ensure product quality performance by mitigating manufacturing variability during the production ramp-up phase.
- Ensure rigorous production process validations (IQ/OQ/PQ) on time, scaling them precisely for each planned capacity step.
- Ensure seamless transfer of validated production processes, technical product knowledge, and manufacturing risk mitigations across different manufacturing facilities and global production sites.
- Evaluate supplier selection and technical capability with a view to implementing strategic single- or dual-sourcing risk mitigations.
- Ensure part qualification and secure formal approval from FME teams to supply parts via a signed Part Submission Warrant (PSW).
- Ensure supplier target cpk, scrap rates, and production yield are achieved.
- Validate that suppliers have the installed equipment and scheduled shifts required to hit capacity targets, proving readiness through successful Overall Equipment Effectiveness (OEE) trial runs
- Confirms the entire product portfolio and all its variants have appropriate regulatory clearances for commercial release and launch.
- Drive end-to-end demand, capacity, and inventory planning across the complete value chain, connecting Sales, the Manufacturing Supply Chain (MSC), and external Suppliers to prevent shortages or excess inventory.
Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions.
PHYSICAL DEMANDS AND WORKING CONDITIONS:
- The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Will require 20% to 50% travel, both domestic and international.
EXPERIENCE AND REQUIRED SKILLS:
- Minimum bachelor’s degree in biomedical engineering, Manufacturing Engineering or related engineering field. Advanced Degree preferred
- 15 years of comparable business experience in program management, project management, and product innovation
- 10 years in medical device industry leading complex cross-functional programs.
- Experience in leading product development in multicomponent therapy systems.
- Experience in leading industrialization of large volume medical device products.
- Ability to drive program results by taking cross-functional team along and collaboration.
- Ability to create, alignment, collaboration and accountability by leading global complex cross functional teams
- Ability to solve complex, extensive, and sometimes contradictory information to solve problems effectively.
- Have experience with converting complex launch requirements into clear plans, milestones, ownership and measurable outcomes
- Effectively communicates with the cross-functional team and all levels in the organization
- Must be creative and use most effective and efficient ways to get tasks done, with a focus on continuous improvement.
- Must understand product development, manufacturing processes, equipment validation, quality and supply chain dependencies sufficiently to identify and resolve industrialization risks
- Ability to manage risks quickly.
- Strong business acumen applies knowledge about the business and market to drive the organization’s objectives.
- Strong experience using data, risk and business priorities to make timely decisions and escalates critical issues.
- Ability to build strong customer relationships and deliver customer-oriented solutions.
- Ability to anticipate future opportunities and translates them into breakthrough strategies.