Excellent New Product Introduction Project Leader

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

The chosen candidate will work as part of an excellent team, working together to develop solutions that promote patients’ quality of life globally.

Responsibilities

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

- Timelines

- Budget

- Procurement

- Suppliers management

- 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:

- Manufacturing

- Sterilization

- Supply

• Writing Specs for:

- Molds, Jigs, Machines, Materials and Processes

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

- Work instructions

- Manufacturing procedures

- Writing/Approving validation plans

• Writing and management of project-related documents
• 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 engineering, or industrial engineering
• 2+ years of experience as an NPI engineer or leader, managing vendors in Israel and abroad - 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
• Fluent in English – speaking, writing, and reading, including writing protocols and reports – a must
• Required Capabilities:

- Excellent teamwork and communication skills

- Excellent interpersonal skills, including management interfaces

- Excellent negotiation and 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 – traveling is required.

At DALI, we support hybrid work.