Manufacturing Engineer II

About Avive: Avive Solutions, Inc. (https://avive.life) is a growth stage Automated External Defibrillator (AED) company with a connected response system that is rapidly gaining market share. We are a mission driven team that is quite literally saving lives. Sudden Cardiac Arrest (SCA) is a leading cause of death in the United States, and we are on a mission to change that! We are a dynamic organization that builds elegant, creative solutions to solve complex problems. Ultimately, our mission is for all cardiac arrest victims to have rapid access to life-saving defibrillation. Avive is taking a fresh approach to addressing this decades-old problem by innovating AED technology, coupled with a first-of-its-kind software platform solution to enable a quicker and more streamlined response to SCA emergencies. We believe that this unique combination of deploying advanced – yet still accessible – hardware, and software, has the potential to revolutionize out-of-hospital cardiac arrest response and massively impact SCA survival rates. Check out this short video that shows a glimpse of how our team is working to re-think cardiac arrest response and save lives! https://www.youtube.com/watch?v=2p4zfOWo62E Learn more about working at Avive: https://avive.life/careers/ About the Role: The Manufacturing Engineer II will work in deep collaboration with the Operations, Research & Development, and Quality functions to develop and sustain production processes to efficiently manufacture our products within Avive’s manufacturing operations and with our contract manufacturing supply base. What you'll do:

• In collaboration with Research & Development, Operations, and Quality, responsible for developing, maintaining, and improving manufacturing procedures, work instructions and test procedures for different Avive products.
• Plan and supervise in-house production activities to fulfill the demand.
• Provide DFM feedback and initiate process improvement projects to drive down product cost and streamline operations.
• Initiate and lead tool and equipment development projects to drive down product cost and streamline production process.
• Implement lean manufacturing concepts/principles to streamline operations and increase efficiency.
• Comply with FDA 21 CFR Part 820 Quality System Regulations and ISO 13485:2016 used in the Medical Device Industry.
• Author Material Specifications (MSs), Tool Specifications (TSs), Equipment Specifications (ESs) and configure Bill of Materials (BOMs) per the product structure in accordance with Avive’s quality system.
• Author test protocols, perform testing, and author reports to support test method validation (TMV) and process validation (IQ, OQ, PQ) in accordance with FDA 21 CFR Part 820 and ISO 13485 quality system regulations.
• Train and supervise technicians for manufacturing operations to effectively build the product and verify the product’s performance to specification.
• Gather process data and perform statistical analysis to determine trends and perform root cause analysis.
• Identify the root cause of manufacturing process and product nonconformities, implement necessary actions to correct and prevent recurrence though the corrective and preventative action process.
• Participates in third party and internal quality audits involving areas of responsibility. Assists with related corrective/preventive action planning and implementation.
• Support operations functions outside areas of direct responsibility including but not limited to Supplier Quality and Supply Chain/Warehouse Management.

Required Skills & Experience:

3 years of relevant experience with Bachelors Degree in Mechanical Engineering, Manufacturing Engineering or closely related field.

Understanding of Lean Manufacturing and Six Sigma, certification preferred (Green Belt, Black Belt).

Experience in high-volume manufacturing, preferably in the medical device industry.

Strong understanding of process validations (IQ, OQ, PQ) per FDA 21 CFR Part 820 and ISO 13485 Quality System Regulations.

Working knowledge of manufacturing processes such as Injection Molding, Additive Manufacturing, Machining, Welding, etc.

Experience in Windows applications including Microsoft Office and Excel.

A self-motivated team player with excellent verbal and written communications skills. Must be able to convey business and technical concepts to diverse stakeholders and technical teams in a clear and concise manner.

Bonus Points For:

• Experience in Statistical methodologies: DOE, SPC, etc.
• Experience with programming language: Python
• Experience with CAD systems: SolidWorks (or equivalent).
• Experience with risk management, including Process Failure Mode Effects Analysis (pFMEA), fault tree analysis, or other risk management tools.