NPI & CI Engineer (New Product Introduction & Continuous Improvement)

Would you like to contribute to improving the quality of life of people with hearing loss?

At Oticon/ITSA Medical, we develop, produce, and market bone-anchored hearing systems.

At our site in Vallauris (Sophia Antipolis), in the south of France, we specialize in the production of active implantable Class III medical devices and will soon manage the worldwide distribution of the company’s full product portfolio. The site also hosts an R&D team and the French sales organization.

As part of our ongoing growth and operational excellence strategy, we are looking for an NPI & CI Engineer (New Product Introduction & Continuous Improvement) to support us in leading industrial projects and driving continuous improvement across our operations.

Reporting to the Operations Department, the role is built around two complementary strategic pillars: on one hand, operational project management for new product introductions (NPI) or changes to existing products, ensuring coordination between the various departments and sites throughout the design transfer phase; and on the other hand, acting as an Operational Excellence Leader across manufacturing, distribution, engineering, maintenance and purchasing activities, by identifying improvement opportunities and defining, in partnership with the relevant managers, a performance roadmap with estimated annual financial and non-financial gains.

Main Tasks: 

Part 1: New Product Introduction (NPI) & Change Management

• Design Transfer Regulation: Regulate the operations activities for the design transfer phase of the introduction of new products insuring the coordination between the different departments and different sites.

• Manufacturing Setup & Ramp-up: Coordinate the operation tasks on site to set up the manufacturing processes and the actions for the ramp-up and launch activities within Operations.

• Early Lifecycle Collaboration: Collaborate in the project planning & execution from early concept phase according to Development Model Procedure.

• Change Control Process: Collaborate in the change control process from change request to release for production with coordination of the needed cross-sites activities with support on the planning & execution of technical changes.

• Regulatory Compliance: Ensure that deliveries comply to medical, regulatory, and internal quality requirements.

Part 2: Operational Excellence

• Design and deploy the Oticon Medical Operational Excellence approach: Measure & baseline the current state through Diagnostic methodology.

• Support and coach the managers in finding opportunities, estimating financial and non-financial gains, and developing an annual Performance roadmap.

• On-the-Floor Implementation: Hands on support the teams to implement actions “on the floor” (write work instructions, define 5’s, eliminate waste, build performance and parts boards, kamishibai, TPM, PCP checklists, audits…) to reach objectives on productivity, service, quality, and consumable cost.

• Apply Lean office methodology for the other functions to optimize strategies and processes

• Lean Coaching & Culture: Act as an Ambassador and constant coach/trainer to develop operational excellence competencies at company level, providing teams with structure and methodology for all their improvement initiatives.

Key Relationships

• Hierarchical Management: 0 supervised teams.

• Internal: Manufacturing, distribution, purchasing, engineering...

• External: Partners, subcontractors, and corporate support teams

Authorities

• Accountable for all the activities related to Operations inside the product development projects.

• Responsible for the timing, content, and quality of the design transfer activities as defined in the project plans.

• Document approval: View, create, edit and revise documents; Sign off for review, publish, approve, obsolete; Read and understood workflows.

• Approval of change requests related to projects: Sign to approve or reject change requests relating to products.

• Escalation of issues to project managers and/or functional managers.

Profile:

Level of Education & Professional Experience:

• A B.Sc. or an M.Sc. engineering degree, business engineering or similar technical background (General Industrial Engineering).

• Between 3 and 5 years of professional experience as a Lean Manufacturing Manager and/or Project Manager developed in manufacturing and engineering environments.

• Experience related in material management, production planning, purchasing and distribution of complex products in regulated industries is an important asset.

• Other experience and knowledge related to quality standards used for medical devices is a plus.

• Fluency in French and English (spoken/written).

Technical & Behavioral Skills:

• Technical:

Master all the Lean Manufacturing tools (Line balancing, problem solving, QRQC, Spaghetti diagram…). 

Facilitate the resolution and handling of a wide range of complex problems with cross-functional teams.

• Behavioral:

On the floor mindset with a strong leadership, pro-active stakeholder management, action-oriented and hands-on approach.

Interpersonal savvy, able to work/coach managers and operators, autonomous, organized, structured, and capable of priority management