- Create, maintain, and improve "low to mid-volume" manufacturing lines, specifying and/or refining BOMs, workflow processes, manufacturing plan and detailed work instructions
- Apply engineering concepts to the optimization of equipment and procedures to achieve better maintainability, reliability, capacity, and availability of equipment.
- Independently and proactively determines and analyzes trends for equipment performance
- Diagnose equipment breakdowns to define and implement improvement strategies.
- Perform installation, repair, and upkeep services for a variety of equipment either in the fields of mechanics and electronics.
- Deal with emergency and unscheduled problems/repairs of equipment
- Design, document, procure, qualify, implement, and improve fixtures, tools, and equipment
- Responsible for creation and upkeep of equipment qualification approaches (IQ/OQ/PQ/DQ) including input from risk documentation and pFMEA
- Responsible for the validation and qualification of manufacturing equipment and processes to production status leveraging standard qualification approaches (IQ/OQ/PQ/DQ)
- Responsible for handling multiple priorities and projects as a matter of routine
- Able to operate independently to develop innovative solutions and processes
- Orchestrates approach to determining root cause and problem solving on complex issues
- Demonstrate leadership through knowledge transfer, mentoring, and training of others
- Conduct testing of software releases before deploying on manufacturing line
- Identify and implement continuous improvement projects with respect to first pass yield, cycle time reduction, product reliability, capacity enhancement and cost reduction
- Execute manufacturing process validations, process FMEAs and other elements associated with production Master Validation Plans
- Maintain compliance with medical device quality system including corrective action closure and Change Order implementation
- Conduct SAP transactions relevant to equipment operations.
- Provide technician training and oversee specified manufacturing stations to ensure quality.
- Contribute to the establishment of group and individual objectives consistent with overall product development goals, including planning, priority setting, establishment of metrics, and effectively communicating progress
- Specify, fit, and integrate new equipment and ensure it is working properly, along with required documentation
- Proactively seeks better and improved technologies for improving production processes
- Provide resource planning and budget estimates for product and process improvements, tooling development, and testing
- Improve existing documentation for equipment installation, repair, and upkeep.
- Responsible for review of peer edits to documentation of fixtures, tools and equipment.
- Strong technical analytical and troubleshooting skills
- Must possess strong communication skills to interface with many teams
- Strong organizational skills and proven ability to work on several fast-paced projects simultaneously
- Prior experience with technical writing
- Minimum BS degree in Mechanical Engineering, Mechatronics, Electrical Engineering, Industrial Systems Engineering, or similar relevant experience.
- Minimum 3 years of experience as design or manufacturing engineer supporting product with significant mechanical, electromechanical, or electro optical content.
- Prior responsibility for process, equipment, or product validation/verification
- Occasional travel to the other ISI offices will be required
- Mechanical CAD software experience (SolidWorks or equivalent) is a plus
- Programming skills is a plus
- Experience in an ISO 13485, ISO 9001, or medical device manufacturing environment a plus
- Prior experience with complex device manufacturing is a plus
- Previous experience with ERP systems (preferred SAP) is a plus
- Experience with line duplication and/or transfer is a plus
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Equipment Engineer - Blacksburg, United States - Intuitive
Description
Company DescriptionAt Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.
As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.
Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.
Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.
Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care.
Job Description
Primary Function of the Position
Contribute your technical manufacturing and equipment design skills to a dynamic development and manufacturing team that creates sensing platforms for minimally invasive robotic surgery. The role requires active participation in new product development teams that create and refine electro-mechanical components, assemblies, process documentation, tooling and test methods while challenging new product designs to improve efficacy, reliability, manufacturability and cost for robotic surgical instruments.
The candidate must be able to coordinate their efforts with the development and manufacturing teams, and be able to report progress and milestones relative to the overall project. He or she must excel in a high-energy team environment and be capable of making sound decisions when faced with the time pressures and incomplete information typical of new product development and early stage manufacturing environments.
Essential Job Duties
Required Skills and Experience
Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.
Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.
We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target salary ranges are listed.
