Manufacturing Operations Manager

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 lives! [https://youtu.be/0AS%5Fpyg4RB8>

Job Description

• Plan, 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 KPls 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.
• Assists with related corrective/preventive action planning and implementation.
• Interface with Quality group to resolve Manufacturing related CAPAs using different quality tools such as 5whys, 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 Manufacturing
• Automation/Robotics
• Plant Layout and Material Handling
• Lean Manufacturing Principles, Six Sigma Problem Solving
• Quality Control and Statistical Process Control using software such as Minitab Statistical analysis software
• DOE - Design of Experiments
• Application of Quality Tools including 5Whys, Cause and effect diagrams, pareto charts for continuous improvement activities
• FDA 21 CFR Part 820 and ISO 13485 Quality System Regulations
• Mechanical 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