Excellent New Product Introduction Project Leader

DALI Medical Devices, a company founded in 2003, specializing in development of novel injectable drug delivery devices, for global pharma and medical device companies, is looking for an talented & experienced excellent NPI project leader that will be a part of the Operations unit and help transfer projects from development to production.

The chosen candidate will work as part of an excellent team, who work together on developing solutions which promote patients’ quality of life globally.

Responsibilities:

Overall responsibility for transferring a product from design to production as far as:

o   Timelines

o   Budget

o   Procurement

o   Suppliers management

o   Production launching

Close work with DALI’s R&D to ensure design requirements are adequately defined and met.

Partnership with DALI’s QA department

Suppliers management: definitions, sourcing, negotiating, control and improve work processes of suppliers locally and abroad in the areas of:

o   Manufacturing

o   Sterilization

o   Supply

Writing Specs for:

o   Molds, Jigs, Machines, Materials and Processes

Writing SOPs to support manufacturing processes of new products and implement design and change controls

o   Work instructions

o   Manufacturing procedures

o   Writing/Approving validation plans

Writing and management of project related documents (Simploud system)

Define and manage processes via ERP system

Work closely with our customers to make sure requirements are met

Qualifications

• Bachelor’s degree in mechanical, biomedical or industrial engineering, preferably from a distinguished university
• 2+ years of experience as an NPI engineer or leader, managing vendors in Israel and abroad - a must
• Fluent in English – speaking, writing, and reading, including writing protocols and reports – a must.
• 2+ years' of experience in the medical devices field, preferably in disposable devices, plastics and/or drug delivery devices – a significant advantage
• Understanding of QA and validation processes – a significant advantage
• High level of proficiency in the requirements of medical device development, regulation, ISO 13485, Risk Analysis - an advantage
• Proven experience with SolidWorks, PDM and ERP systems – an advantage
• Supply chain knowledge – an advantage.
• Excellent technical skills and understanding, especially in design, molding & plastics and automation.

Required Capabilities:

• Excellent communication, teamwork and interfaces management
• Excellent negotiation & assertiveness skills
• Ability to work under tight schedules and uncertainty
• Multi-tasking and prioritizing abilities
• Highly motivated and looking to excel

This job is full time.

The role will be performed at DALI’S offices, located in Yavne (15 min. from Tel-Aviv, in the vicinity of Yavne West train station), and in the manufacturing plants of our subcontractors – travel is required.

At DALI, we support hybrid work.

Please submit CVs here or send to: [email protected]