Job Description

Curt Koland Recruiting is looking for candidates who are passionate about developing innovative medical technologies that can significantly improve patient outcomes. Our client is a growing Medical Device company with intelligently designed and engineered products.

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We are looking for engineering candidates currently living in the San Francisco Bay Area with 5 or more years of experience in the Medical Device industry or a closely related field. Candidates must possess either US Work Authorization or US Citizenship. We are not able to accommodate H-1B Visa transfers at this time.

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Responsibilities:

• Senior technical resource for processes, systems, and equipment for Manufacturing Engineering. Requires detailed technical knowledge of processes and systems. Must be able to develop new processes, optimize existing processes and systems, and design for future requirements.
• Develop Manufacturing Engineering projects to improve quality, capacity, and cost. Lead cross-functional stakeholder groups for projects. Analyze benefits vs investment for initiatives. Manage projects and resources from initiation to implementation on-time and on-budget.
• Apply internal and external resources to appropriately address Manufacturing Engineering requirements.
• Mentor junior engineers and technicians in the organization.
• Resolve manufacturing equipment issues.
• Work with the R&D team to develop and optimize manufacturing processes.
• Maintain compliance with FDA and ISO guidelines for medical device development and manufacturing.

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Qualifications:

• Minimum 5 years relevant experience in the medical device industry Manufacturing Engineering (ME); preferably including Class III implants.
• Technical project management experience. Some experience managing engineers is a plus.
• Experience with technical writing; TP/TR, IQ/OQ/PQ, etc., with documentation sufficient for regulatory submissions.
• Knowledge of Statistics and Data Analysis.
• Solid operational project management experience together with the ability to work in a collaborative environment.
• Excellent communication, both verbal and written and people skills.
• Advanced MS Excel and Word skills. SolidWorks is a plus.
• Experience integrating automation stations, programming PLC (Arduino), computer-controlled machinery.
• Experience with ERP systems such as QAD, Oracle, SAP or similar is a plus.
• Experience with electronic Quality Management Systems such as Arena is a plus.
• This is not an entry-level role.

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Education:

• Bachelor’s or Master's degree in Mechanical Engineering or equivalent

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