Responsible for leading engineering projects as they relate to Sonendo’s process development and sustaining activities with disposable products.
- Routinely leads cross-functional project teams.
- In a cross functional environment, has broad responsibility for process development and sustaining activities.
- Leads and directs groups of technical personnel when transferring new products to production.
- Primary interface with suppliers and contract manufactures for product conformance and process issues.
- Develop and qualify high-volume manufacturing processes.
- Design and build production equipment, fixtures and tooling as required.
- Perform IQ, OQ and PQ, including writing protocols and reports.
- Identify and resolve production issues as they arise.
- Produce manufacturing drawings and documentation.
- Leads process training for new processes.
- Develop project schedules and expenses.
- Apply problem solving techniques perform root cause and failure analysis as required. Qualifications
- Requires a BSME or equivalent with 10+years experience.
- Medical device manufacturing experience essential; plastic part assembly, metal fabrication processing, fluidics knowledge, low volume – high pressure fluid systems and low-vacuum systems desirable.
- Demonstrated knowledge of ISO and FDA requirements as they relate to manufacturing and product design.
- Functional with Solidworks, Microsoft Project, Microsoft Word and Excel.
- Knowledge of machine shop practices desirable.
- Must be a hands-on problem solver.
- Must have demonstrated cross-functional team effectiveness, excellent interpersonal and written communication skills.
- Ability to initiate a project and follow-through to completion. Additional Information
Sonendo offers a competitive benefits package and a collaborative, motivating work environment where you will be encouraged to innovate continuously; This is a place where you are required to actively participate – your ideas will have a direct impact on the success of the organization. If you are interested in applying for this position, please apply online.
No recruiters please.
Sonendo, Inc. is an Equal Opportunity Employer
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