Staff Manufacturing Engineer
San Jose, CA
Operations /
Full-Time /
On-site
The Opportunity That Awaits You:
Are you ready to embark on an exciting journey that will revolutionize the way men suffering from BPH are treated? Join us as a Staff Manufacturing Engineer and be at the forefront of engineering technologies for the groundbreaking Aquabeam Robotic System. Your mission? To establish engineering technologies for the operations team to become best in class manufacturers of medical devices and equipment. This isn't just any job - it's a chance to make a real difference. We need someone driven, motivated, and determined to drive new process technologies. Get ready to transform lives and shape the future of healthcare!
What You Day-To-Day Will Involve
- Lead engineering support to manufacturing and resolve issues related to process and equipment (e.g. troubleshoot existing manufacturing processes, fixtures, tooling or equipment)
- Develop training programs for operators and engineers
- Responsible for helping define technology and equipment roadmap for medical device technologies
- Champion continuous improvement by identifying projects to create and support best in class lean manufacturing systems to maximize yield, capacity, and capability
- Identify, justify and implement multiple significant Design for Manufacturability DFM projects to reduce manufacturing costs, improve processes, increase product reliability, and enhance process capability.
- Design and evaluate new and existing fixtures and equipment, test methods, specifications, layouts, and standards.
- Responsible for process documentation and ensuring it is kept current like Manufacturing Instructions, Standard works documents, PFMEA, standard works and Control Plans
- Work with R&D and Process Development teams to develop weld schedule development for transfer of new products into commercial manufacturing, both in-house and at contract manufacturer
- Identify, define and execute new technical projects that improve manufacturing processes – this will include developing the scale, scope and ROI.
- Design, build or procure improved fixtures, tooling or equipment to increase quality, reliability, capacity, and yield
- Provide engineering support to outside suppliers and contract manufacturers, ensuring quality and production targets are met
- Train, develop, and/or provide work direction to operators and technicians
- May require up to 20% travel, domestic and international.
The Qualifications We Need You to Possess
- BS in an Engineering discipline such as welding, mechanical or electrical engineering with a minimum of 8 years’ experience or an MS in Engineering with a minimum of 6 years’ experience.
- Extensive experience with root cause analysis and problem solving for both technical and process issues.
- Experience working in a structured design process such as ISO9000 or FDA QSR, knowledge of regulatory approval process and requirements.
- Working knowledge of design control and cGMP requirements for medical device manufacturing per FDA QSR and ISO13485-2003 or ISO9001and EN46001.
- Basic working knowledge of CAD (Solidworks or other) software.
- Citizen/Permanent Resident required
The Qualifications We Would Like You to Possess
- Recognized as subject matter expert in process technologies such as laser cutting, welding, brazing, and joining.
- Experience supporting medical device manufacturing.
- Experience in leading highly technical projects in a cross functional environment both internally and with CMOs/Vendors.
- Preferred experience with Lean and Six Sigma tools.
- Excellent computer skills with specific skills in Microsoft Office and proficient in SolidWorks.
$162,000 - $191,000 bimonthly
For this role, the anticipated base pay range is $162,000 to $191,000 per year, plus eligibility for an annual bonus of 15% and RSUs.
