Manufacturing NPI & Configuration Leader
Inspira Technologies is an innovative medical device company in the respiratory care industry. Inspira is developing the ART device, a cost-effective early extracorporeal respiratory support system with an intent to function as an “Artificial Lung” for deteriorating respiratory patients. The ART device is designed to utilize a hemo-protective flow approach aimed to rebalance saturation levels while patients are awake and breathing, potentially minimizing the patient’s need for mechanical ventilation.
The product is currently in a developmental stage and has not yet been tested or used in humans and has not been approved by the U.S. Food and Drug Administration (FDA).
For more information, please visit the company website:
We are looking for a Manufacturing NPI & Configuration Leader to be a Member of the Operations department.
In this job you will Provide daily support of products, processes, materials, and equipment to achieve production goals (i.e., quality, delivery, cost, productivity, and safety).
- ISO:13845 & FDA regulations
- Verify multi-disciplinary system requirements, testing & support during V&V process.
- Full responsibility of Component Engineering
- Supporting Process FMEA (Failure Mode and Effect Analysis)
- Supporting Regulatory audits and CAPA process
- Full responsibility on company’s PLM system (Agile) – Open P/Ns, issue BOMs and ECO/DCO
- Lead a complex process – which includes Engineering, Logistics and Testability experience.
- Define and implement production testing tools and jigs.
- Support OEMs with design issues.
- (DFM/A) Review and approve design part for mass production.
- Source and approve (Technical and capability) new suppliers and provide work instruction and quality requirement.
- Production line layout – responsible to implement and verify Verification and validation.
- Support environmental, Reliability and standard tests (i.e. “CE”)
- Support quality control of products: validation, pass-fail criteria, testing requirements implementation.
- Relevant degree (Industrial & management engineer for instance)
- Experience in working with PLM system – Agile is advantage
- At least 5 years of experience in the Engineering/NPI fields
- Experience in transfer to production /NPI in the medical field
- Very good English with experience in writing engineering documentation, such as reports and tool files
- A team player, open minded with good communication skills
- Willing to multiple trips abroad