Manager Contract Manufacturing

3 maanden geleden

Utrecht, Nederland ViCentra Voltijd

About ViCentra

ViCentra is an innovative medical device company based in Utrecht, The Netherlands. ViCentra focuses on the research and development, manufacturing and commercialization of a ground-breaking device for the management of diabetes.

Kaleido, the smallest and lightest insulin pump system currently available, is designed to help people with diabetes live life on their own terms:

- "For us, super accurate insulin delivery and improved control are non-negotiables, but discretion, simplicity and choice is our way of helping you live life in your own way"._

Driven by ViCentra's desire to be meaningfully different, Kaleido aims to reduce the impact that diabetes can have on daily life. Utilizing Bluetooth wireless technology, Kaleido infuses colour and choice into the market, networking its hybrid patch pumps and handsets into a broader family of easy-to-use products and data services to create a customer-focused, integrated diabetes support service.

With CE mark, in-house software development and manufacturing, ViCentra is setting its sights on expanding insulin pump usage by appealing to both first time and experienced insulin pump users in the Netherlands. At the same time, we are preparing for FDA approval expansion into additional territories and establishing partnerships in digitalization and connectivity.

Funded by the venture capitalists LSP, INKEF, Invest-NL, Partners in Equity, and Health Innovations, ViCentra currently employs over 100 people from over 30 different nationalities.

The position

We are seeking a manager contract manufacturing to join our rapidly growing medical device manufacturing organization. In this position you will be responsible for our external manufacturing processes, supplier development and ensuring the successful execution of ViCentra Manufacturing Scaling objectives. This role involves defining and governing strategies and processes that support targets related to capacity development, product quality, delivery, and strategic cost objectives. You will oversee the day-to-day technical operations of contract manufacturing and critical component suppliers, impacting key performance indicators such as cycle time, OEE, and yield.
- Main Responsibilities include but are not limited to:_
- Define and (re)negotiate “SMART” master supply agreements with CMO in liaison with ViCentra Procurement driving performance and continuous improvement on capacity and cost.
- Hires, develops and manages a team of engineers to meet company objectives.
- Align long term scaling strategy with contract manufacturer and ensure the right scaling projects are established. ViCentra Procurement tracks day-to-day/week by week progress to the plan as part of ViCentra’s planning process.
- Leads Quarterly business reviews with CMO and participates in monthly calls led by Procurement.
- Portfolio Management of all projects impacting ViCentra’s CMO, while interacting with individual project managers on product development, scaling, quality improvement and cost reduction projects.
- Monitors overall project spend on CMO while keeping individual ViCentra project managers accountable for their project budgets.
- Initiates, reviews and approves specific operations projects at CMO and manages these projects in the initial phase and ensures projects stay on track.
- Create and maintain the PMO project baselines and project risk log for those projects. Provide recurring project reporting within the PMO process.
- Leverage ViCentra’s PMO framework to execute projects with the right priority and return on investment between ViCentra and the CMO.
- Hosts and facilitates recurring project calls to track progress, performance, setting priority or support in overcoming issues on a need by basis. When issues arise on performance, clear improvement actions are defined, agreed and implemented.
- Improve key business processes between ViCentra and the CMO involving the departments interfacing with the CMO; R&D, Quality, Process Engineering, Industrialisation and Automation, Procurement, Finance
- Acts as escalation point for CMO process engineers in case issues are experienced during projects or daily production which the CMO cannot resolve.
- Leads process engineering activities delegated to CMO, including manufacturing processes, tooling, equipment, fixtures.
- Supports a continuous improvement culture between ViCentra and the CMO utilizing continuous improvement techniques as applicable.
- Reviews manufacturing plans, process specifications, procedures, work instructions on a need by basis.
- Reviews documentation related to verification/validation of processes, machines and equipment including IQ/OQ and PQ protocols on a need by basis.
- Ensure legal and regulatory compliance requirements are met and processes are executed in line with ISO 13485 certification.
- Required:_
- Bachelor of Science degree in Mechanical, Manufacturing or Industrial Engineering, or related engineering degree.
- 7-10 y

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