Manufacturing Operations Manager
Vor 2 Tagen
Avive Solutions, Inc. (https://avive.life) is a VC-backed healthcare technology company that has developed an FDA approved, next-generation Automated External Defibrillator (AED) and response system in an effort to –literally– save 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 team 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 providing an advanced AED technology, coupled with a first-of-its-kind software platform solution to enable a quicker and more streamlined response to cardiac arrest emergencies.
We believe that this unique combination of deploying advanced – yet still accessible – hardware, and novel 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 liveshttps://youtu.be/0AS_pyg4RB8 Job DescriptionPlan, design, implement and validate manufacturing processes for production.Lead efforts to develop manufacturing processes and procedures from early R&D concept/prototype phase performing hands on assembly through design/manufacturing transfer, process validation and product launch scaling to high volume manufacturing.Lead cross functional teams to set up and qualify high-volume production facility in compliance with common good manufacturing practices (CGMPs) and applicable FDA and ISO quality system regulations.Comply with FDA 21 CFR Part 820 and ISO 13485:2016 quality system regulations used in the Medical Device Industry.Propose and execute growth strategies for the manufacturing team, write job requisitions, conduct interviews and hire necessary personnel.Develop and manage KPIs for the manufacturing process across all production lines.Manage manufacturing equipment/tool design, implementation on production line, and validation for high volume production.Author Material Specifications (MSs), Tool Specifications (TSs), Supply Specifications (SSs), Standard Test Methods (STMs), Bill of Material (BOM), Lot History Records (LHRs), Manufacturing Process Instructions (MPls) in compliance with common good manufacturing practices (CGMPs) set forth by FDA.Lead process improvement teams to analyze and improve existing processes using Lean Manufacturing principles.
Coordinate with appropriate suppliers and other external resources needed in developing and implementing process improvement plans.Use Statistical Process Control concepts and Minitab Statistical Analysis software to analyze process data.Author test protocols, perform testing, and author reports to support test method validation (TMV), design verification, design validation, process validation (IQ, OQ, PQ), intended use validation (IUV), flowcharts, PFMEA, DOE, Gage R&R in accordance with FDA and ISO quality system regulations.Generate detailed fabrication drawings using SolidWorks with familiarity of GD&T and tolerance stack up analysis.Lead packaging design, configuration design, and packaging validation testing to ensure safe packaging.
Participate in FDA, ISO and internal quality audits involving areas of responsibility.Assist with related corrective/preventive action planning and implementation.Interface with Quality group to resolve Manufacturing related CAPAs using different quality tools such as 5 Whys, cause and effect diagram, etc.
and problem solving methodologies such as Six Sigma.Contribute to operations functions outside areas of direct responsibility including but not limited to Supplier Quality and support fulfilling requirements such as supplier assessments, audits, continuous improvement, etc.Provide mentoring and training to Manufacturing Engineering Technicians and Manufacturing Engineering Assistants in subjects such as equipment maintenance and repair, machine programming and optimization, and other areas of responsibility.Mentor and train other Company personnel concerning areas of responsibility.
Telecommuting allowed for this position.Minimum Qualifications:The position requires a Master's degree in Manufacturing Engineering, Mechanical Engineering, or closely related field plus one (1) year of experience in manufacturing engineering.The position requires any amount of experience in all of the following:
Manufacturing Technologies/processes: injection molding, machining, welding, Additive ManufacturingAutomation/RoboticsPlant Layout and Material HandlingLean Manufacturing Principles, Six Sigma Problem SolvingQuality Control and Statistical Process Control using software such as Minitab Statistical analysis softwareDOE - Design of ExperimentsApplication of Quality Tools including 5 Whys, Cause and effect diagrams, Pareto charts for continuous improvement activitiesFDA 21 CFR Part 820 and ISO 13485 Quality System RegulationsMechanical Engineering Concepts: Machine Design, Engineering Mechanics Telecommuting allowed for this position at times.
Equal Employment Opportunity It is the policy of the company to provide equal employment opportunity to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law.
In addition, the company will provide reasonable accommodations for qualified individuals with disabilities.
NOTE: This Job Description in no way states or implies that these are the only duties or functions to be performed by the incumbent.
Personnel are required to follow any other job-related instructions and to perform any other job-related duties/functions requested by their supervisor.
Anticipated salary range: $120,000-$160,000* Annually *Depending on experience
#J-18808-Ljbffr
-
Manufacturing Operations Manager
Vor 2 Tagen
Brisbane, Österreich Avive Solutions, Inc VollzeitAvive Solutions, Inc. () is a VC-backed healthcare technology company that has developed an FDA approved, next-generation Automated External Defibrillator (AED) and response system in an effort to –literally– save 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...
-
Manufacturing Operations Manager
Vor 2 Tagen
Brisbane, Österreich Avive Solutions, Inc VollzeitAvive Solutions, Inc. () is a VC-backed healthcare technology company that has developed an FDA approved, next-generation Automated External Defibrillator (AED) and response system in an effort to –literally– save 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...
-
Senior Manager Business Process Excellence
vor 1 Stunde
Brisbane, Österreich Brooks Automation VollzeitSenior Manager Business Process Excellence - Manufacturing Operations and QABrooks is a growing, fast-paced technology leader of automation solutions which support the dynamic and expanding semiconductor and life sciences lab markets.Our customer-focused culture encourages employees to embrace innovation and collaborate with one another to achieve new...
-
Brisbane, Österreich Recruitment Partners VollzeitSenior Operations Accountant | Manufacturing, Inventory & CostingAbout the roleReporting to the Financial Controller and Plant Manager within a global manufacturing business headquartered in Brisbane, this Senior Operations Accountant role has been created to act as the conduit between finance and its large-scale manufacturing operations. You will be...
-
Senior Manager, Business Process Excellence
Vor 5 Tagen
Brisbane, Österreich Brooks Automation VollzeitBrooks is a leading provider of automation solutions with over 40 years of experience in the semiconductor industry, offering precision robotics, integrated automation systems, and contamination control solutions that empower chip manufacturers worldwide. Our product portfolio includes a range of automation solutions, including robots, vacuum systems, and...
-
Senior Manager, Business Process Excellence
Vor 3 Tagen
Brisbane, Österreich Brooks Automation VollzeitBrooks is a leading provider of automation solutions with over 40 years of experience in the semiconductor industry, offering precision robotics, integrated automation systems, and contamination control solutions that empower chip manufacturers worldwide.Our product portfolio includes a range of automation solutions, including robots, vacuum systems, and...
-
Brisbane, Österreich Tideri Jobbörse VollzeitAvive Solutions, Inc. ( ) is a VC-backed healthcare technology company that has developed an FDA approved, next-generation Automated External Defibrillator (AED) and response system in an effort to –literally – save 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...
-
Senior Manager, Business Process Excellence
Vor 2 Tagen
Brisbane, Österreich Brooks Automation VollzeitSenior Manager, Business Process Excellence - Manufacturing Operations and QualityApply locations Australia - Brisbane time type Full time posted on Posted 30+ Days Ago job requisition id R2366Brooks is a leading provider of automation solutions with over 40 years of experience in the semiconductor industry, offering precision robotics, integrated automation...
-
Senior Manager, Business Process Excellence
vor 15 Stunden
Brisbane, Österreich Brooks Automation VollzeitSenior Manager, Business Process Excellence - Manufacturing Operations and Quality Apply locations Australia - Brisbane time type Full time posted on Posted 30+ Days Ago job requisition id R2366 Brooks is a leading provider of automation solutions with over 40 years of experience in the semiconductor industry, offering precision robotics, integrated...
-
Manufacturing Manager
vor 2 Monaten
Brisbane, Österreich Sharp & Carter Supply Chain VollzeitManagement (Manufacturing, Transport & Logistics) Full timeWhy should you apply?Our client is a significant player in the Australian FMCG industry with a global presence, specialising in production and supply across both fresh and prepared foods.Currently undergoing rapid change management due to growth, this is a fantastic opportunity to shape the future of...
-
Manufacturing Manager
vor 2 Monaten
Brisbane, Österreich Sharp And Carter VollzeitManagement (Manufacturing, Transport & Logistics) Full time Why should you apply?Our client is a significant player in the Australian FMCG industry with a global presence, specialising in production and supply across both fresh and prepared foods.Currently undergoing rapid change management due to growth, this is a fantastic opportunity to shape the future...
-
Manufacturing Manager
vor 2 Monaten
Brisbane, Österreich Sharp And Carter VollzeitManagement (Manufacturing, Transport & Logistics)Full timeWhy should you apply?Our client is a significant player in the Australian FMCG industry with a global presence, specialising in production and supply across both fresh and prepared foods.Currently undergoing rapid change management due to growth, this is a fantastic opportunity to shape the future of...
-
Manufacturing Engineer
vor 1 Monat
Brisbane, Österreich Rheinmetall VollzeitManufacturing EngineerRheinmetall Defence Australia Pty Ltd in BrisbaneRheinmetall / Manufacturing EngineerRef. no.: AU02062Contract Type: Permanent Full-TimeWHAT WE ARE LOOKING FORRDA Production and Manufacturing EngineeringThe RDA Operations team will plan and conduct production tasks out of the MILVEHCOE facility at Redbank, QLD. As part of the set-up and...
-
Manufacturing Engineer
vor 1 Monat
Brisbane, Österreich Rheinmetall VollzeitManufacturing EngineerRheinmetall Defence Australia Pty Ltd in BrisbaneRheinmetall / Manufacturing EngineerRef. no.: AU02062Contract Type: Permanent Full-TimeWHAT WE ARE LOOKING FORRDA Production and Manufacturing EngineeringThe RDA Operations team will plan and conduct production tasks out of the MILVEHCOE facility at Redbank, QLD. As part of the set-up and...
-
Manufacturing Engineer
vor 1 Monat
Brisbane, Österreich Rheinmetall Defence Australia Pty Ltd | Brisbane VollzeitManufacturing EngineerRheinmetall Defence Australia Pty Ltd in BrisbaneRheinmetall / Manufacturing EngineerRef.no.: AU02062Contract Type: Permanent Full-TimeWHAT WE ARE LOOKING FORRDA Production and Manufacturing EngineeringThe RDA Operations team will plan and conduct production tasks out of the MILVEHCOE facility at Redbank, QLD.As part of the set-up and...
-
Brisbane, Österreich Tideri Jobbörse VollzeitBrooks is a leading provider of automation solutions with over 40 years of experience in the semiconductor industry, offering precision robotics, integrated automation systems, and contamination control solutions that empower chip manufacturers worldwide.Our product portfolio includes a range of automation solutions, including robots, vacuum systems, and...
-
Finance Manager | Manufacturing
vor 3 Wochen
Brisbane, Österreich Quinn Allan VollzeitQuinn Allan is currently partnering with a manufacturing company that is part of a global network.Our client is looking for an experienced Finance Manager to oversee all financial aspects of the business and actively engage in the implementation of best practices, enhancing processes, and shaping the business's strategic financial direction.About the role...
-
Operations Manager
vor 1 Woche
Brisbane, Österreich Hays Recruitment VollzeitManagement (Manufacturing, Transport & Logistics)Full timeOperations Manager - Steel FabricationYour new companyAn established global organisation, renowned for its diverse manufacturing processes, is seeking an experienced Operations Manager to develop and optimise a greenfield facility dedicated to the fabrication of large-scale steel and aluminium...
-
Brisbane, Österreich Tideri Jobbörse VollzeitSenior Operations Accountant | Manufacturing, Inventory & Costing About the roleReporting to the Financial Controller and Plant Manager within a global manufacturing business headquartered in Brisbane, this Senior Operations Accountant role has been created to act as the conduit between finance and its large-scale manufacturing operations.You will be...
-
Operations Coordinator
vor 4 Wochen
Brisbane, Österreich Criterion Industries Pty VollzeitOperations Coordinator - Queensland (Manufacturing and Warehouse)Join Criterion! Drive operations, manage inventory, and support logistics in a collaborative workplace where you'll thrive in a Great Place to Work!About the RoleWe are seeking a proactive and detail-oriented Operations Coordinator to join our QLD branch in Eagle Farm. In this hands-on role,...
