Full Job Description

Quality Manufacturing Engineer

Looking for a highly motivated and experienced Quality ManufacturingEngineer to partner with Customer Product Development, Manufacturing Team’s initiatives, and maintain QMS compliance with the applicable Standards and Regulations.As a Quality Manufacturing Engineer, you will be a Subject Matter Expert (SME) in a variety of projects, which include leading validations, NPIs, as well as specific customer project scope with a focus on Additive Manufacturing, GMP, Process Equipment, and Facilities.

This individual will drive product quality, safety, design, and reliability through the R&D/Product Development and Quality teams and into the product. This individual will actively participate in risk management, design concepts, design specifications, design for quality and manufacturing requirements, process/technology development, product verification/validation, and associated documentation.

Job Description:

• Support new product introduction projects through development and execution of process validation and verification test plans, protocols, and report
• Ensure stabilization of new product launches through steady-state processes.
• Monitor the continuous improvement of product requirements, verification strategies, and validation strategies across design and manufacturing changes.
• Support design and process changes throughout commercialization of product lives
• Ensures continued product development compliance with FDA QSR (21 CFR 820), ISO13485:2016, MDSAP, and other applicable regulations
• Activities would drive prevention, detection of defects to improve/stabilize product launches, continuous improvement & customer satisfaction.
• Provide statistical support, expertise and analytical problem solving for sustaining activities, including development and manufacturing.
• Works directly with internal customers, design, manufacturing, and other groups to develop appropriate equipment specifications for calibration and preventative maintenance (PM), such as parameters, intervals, tolerances, acceptance criteria and operating limits for new and existing equipment and systems.
• Ensures inspection and sampling plans, test methods, and transfer functions for products and components are in place and working accordingly
• Participates in investigations of non-conformances, driving consistencies in manufacturing and design
• Contributes to CAPA investigations and solution verification
• Executes projects and assignments with technical responsibility
• Supports the Risk Management process per ISO 14971 and construction / maintenance of the Risk Management File.
• Support the implementation of quality management system (QMS) documentation to ensure compliance with the quality manual and associated Regulations.
• Plan and direct creation of quality standards, quality control, and quality assurance procedures, sampling plans, test methods, fixtures, and processes for finished devices
• Perform DHF/DHR review for product release.
• Ensures outside supplier quality systems meet requirements and coordinates any activities with the supplier as needed
• Participate in internal, third party and customer audits.
• Assist the Quality Department with other applicable tasks as assigned.

Qualifications:

• Bachelor’s degree with 3-5 years of related experience
• Experience working in a cross-functional team environment
• Proficient technical writing skills and use of documentation programs.
• Working knowledge of fundamental quality and statistical tools and familiarity with a statistical software package (Minitab, JMP, SAS, SPSS, etc.)
• Familiarity with FDA QSR, and ISO 13485 medical device regulations and standards (required); MDSAP (preferred)
• Certified ISO 13485 Lead Auditor a plus
• Additive Manufacturing (AM) experience a plus

Job Type: Full-time

Pay: $80,000.00 - $100,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• Monday to Friday

Ability to commute/relocate:

• Cincinnati, OH 45249: Reliably commute or planning to relocate before starting work (Preferred)

Education:

• Bachelor's (Preferred)

Experience:

• Additive Manufacturing: 3 years (Preferred)

Work Location: One location

Apply Now

Full Job Description

Medical Operations Manager

NEED:

Vertex Manufacturing, a Printerprezz company, is building a world-class medical manufacturing facility in Cincinnati, Ohio, and is currently searching for the right candidate to lead our operations group and build a best-in-class manufacturing capability. Deep domain expertise of medical implant, instrument, and device manufacturing is a must. Vertex is vertically integrating metal additive manufacturing, CNC machining, thermal processing, part marking, abrasive blasting, inspection, cleaning, passivation, and packaging of titanium and polymer implants, stainless steel instruments, and a variety of other medical products.

Successful candidates:

• Are well experienced in medical manufacturing
• Thrive with advanced technologies and talented team members
• Strive to build best-in-class cultures of innovation and efficiency
• Driven to succeed and continually improve operations

If you feel you have the skillset, experience, and expertise to elevate our organization please submit your resume today.

CORE RESPONSIBILITIES:

Additional duties may be assigned, but core expectations can be listed as the following:

• Building of team: Manage personnel and ensure positive culture continues. Foster innovation and continuous improvement.
• Drive Production Goal Attainment:
• Safety – Manage safety team and ensure zero accidents
• Schedule – Drive on-time delivery across the operation using tools like Oqton [MES] and others
• Cost – Help track and manage cost targets. Ensure efficiency.
• Quality – Support Quality Manager so the team meets regulatory, customer, and internal requirements
• Medical Manufacturing SME: Be the resident SME for medical manufacturing technologies. Ensure Vertex manufacturing is best-in-class for implant manufacturing. Drive the facility and team to exemplify what is expected in medical manufacturing.
• Job problem resolution: Find solutions for problems on the floor. Leverage proper resources to fix issues as they arise.
• Strategic initiatives: Working with senior leadership identify gaps. Help create and execute strategic plans to mitigate risks.
• Drive Continuous Improvement: Implement and drive formal programs to improve capability, capacity, and overall efficiency

ENVIRONMENT & CULTURE

Vertex Manufacturing is building a unique organization revolving around talented individuals and advanced manufacturing technologies. Hallmarks of the business include:

• Innovation & technology industrialization
• Individual ownership, development & empowerment
• Advanced technologies, equipment, tools, and software
• Positive attitudes & mentorship
• Open communication & information sharing

Job Type: Full-time

Pay: $150,000.00 - $200,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• Monday to Friday

Ability to commute/relocate:

• Cincinnati, OH 45249: Reliably commute or planning to relocate before starting work (Preferred)

Education:

• Bachelor's (Preferred)

Experience:

• Medical Operations: 3 years (Preferred)

Work Location: One location

Apply Now

CORE RESPONSIBILITIES

Additional duties may be assigned, but core expectations can be listed as the following:

• Fixture Build: Leveraging the multitude of technologies within reach, machine and build fixtures for a wide spectrum of applications.
• Machine Setup: Setting and loading tools, loading programs, establishing offsets, locating fixtures, loading parts etc.
• Cutting Stock: Using horizontal and vertical band saws to cut blanks from bar stock.
• Processing parts across multiple CNC machines: Operating mills, lathes, EDMs, etc. Communicate feedback efficiently with program creators and make changes required.
• In-Process Inspection: Measuring parts and fixtures as required.
• Documentation: Filling out the proper paperwork including job travelers, inspections forms and other records.
• Job Quoting: Provide estimates based on experience.
• Conducting Machine Maintenance: Manage day-to-day maintenance of equipment.
• Maintaining Tools and Libraries: Ensuring tooling stock levels are maintained.
• Operating additional equipment: Other duties may be assigned, including the operation of other manufacturing equipment.

 

ENVIRONMENT & CULTURE

Vertex Manufacturing is building a unique organization revolving around talented individuals and advanced manufacturing technologies. Hallmarks of the business include:

• Innovation & technology industrialization
• Individual ownership, development & empowerment
• Advanced technologies, equipment, tools, and software
• Positive attitudes & mentorship
• Open communication & information sharing

CORE RESPONSIBILITIES

Additional duties may be assigned, but core expectations can be listed as the following:

• Fixture Design & Build: Leveraging individual skill set and a multitude of technologies design, machine and build fixtures for a wide spectrum of applications.
• Machine Setup: Setting and loading tools, loading programs, establishing offsets, locating fixtures, loading parts etc
• Machine Programming: At the machine or Offline with CAM depending upon individual experience and skill level. Continue to grow in capability and experience.
• Cutting Stock: Using horizontal and vertical band saws to cut blanks from bar stock.
• Processing parts across multiple CNC machines: Operating mills, lathes, EDMs, etc. Communicate feedback efficiently with program creators and make changes required.
• In-Process Inspection: Measuring parts and fixtures as required.
• Documentation: Filling out the proper paperwork including job travelers, inspections forms and other records.
• Job Quoting: Provide accurate job quoting - including tooling, fixture, programming, stock, run time, and inspection costs. Coordinate bids from inside and outside resources when required.
• Conducting Machine Maintenance: Manage day-to-day maintenance of equipment.
• Maintaining Tools and Libraries: Ensuring tooling stock levels are maintained.
• Customer Interaction: Communicate with Vertex customers as required – retrieving information, providing status updates, promoting capabilities, and/or instilling confidence 
• Mentor: Educate and train less-experienced employees.

 

ENVIRONMENT & CULTURE

Vertex Manufacturing is building a unique organization revolving around talented individuals and advanced manufacturing technologies. Hallmarks of the business include:

• Innovation & technology industrialization
• Individual ownership, development & empowerment
• Advanced technologies, equipment, tools, and software
• Positive attitudes & mentorship
• Open communication & information sharing

CORE RESPONSIBILITIES

Additional duties may be assigned, but core expectations can be listed as the following:

• Machine Programming: Utilizing Offline CAM software, program tool paths for multiple CNC machines. Create set-up sheets or documentation required for machinist and operators to follow. Edit programs based on feedback from shop floor personnel.
• Fixture Design & Build: Design, machine and build fixtures for a wide spectrum of applications. Create drawings and models accordingly.
• Machine Setup: Specify the tools and set-up required to execute developed programs on machines. Be able to set and load tools, load programs, establish offsets, locate fixtures, and load parts etc.
• Process parts across multiple CNC machines: Operate mills, lathes, EDMs, etc. R
• In-Process Inspection: Measuring parts and fixtures as required.
• Documentation: Filling out the proper paperwork including job travelers, inspections forms and other records.
• Job Quoting: Provide accurate job quoting - including tooling, fixture, programming, stock, run time, and inspection costs. Coordinate bids from inside and outside resources when required.
• Specify Tool Libraries: Develop and spec tool libraries for use with programs. Stay educated on modern tools and methods to ensure efficient and cost effective material removal across a wide variety of materials and applications.
• Customer Interaction: Communicate with Vertex customers as required – retrieving information, providing status updates, promoting capabilities, and/or instilling confidence
• Mentor: Educate and train less-experienced employees.

 

ENVIRONMENT & CULTURE

Vertex Manufacturing is building a unique organization revolving around talented individuals and advanced manufacturing technologies. Hallmarks of the business include:

• Innovation & technology industrialization
• Individual ownership, development & empowerment
• Advanced technologies, equipment, tools, and software
• Positive attitudes & mentorship
• Open communication & information sharing