Manufacturing Process Development Engineer
3 months ago
This position is responsible for aspects of the process design and development of a project with a focus on innovative medical devices that address the customer needs for a complete procedural solution. This role complies to FDA QSR (21 CFR 820), ISO 13485 requirements and adheres to the Quality Management System (QMS).
ESSENTIAL FUNCTIONS:
- Designs fixtures, tools, and machines used to manufacture
- Oversees the development of new processes, methods, and production
- Maintains knowledge of new and developing manufacturing technology, equipment, and applications; applies this knowledge to recommend and implement new technology and processes.
- Perform engineering and data analysis for activities such as validations and engineering studies including DOEs and root cause investigations.
- Generate and review process documentation including but not limited to Manufacturing Process Instructions (MPI), Bill of Materials (BOM), and Lot History Records (LHR).
- Generate and execute Engineering Change Orders (ECO).
- Identify and implement process improvements to increase quality, capacity, and efficiency, while reducing waste.
- Monitor process performance using Statistical Process Control (SPC), and other engineering principles.
- Communicate with customers to understand project needs and set expectations for
- Reviews production program equipment, hardware, and tooling; make recommendations for repairs or replacement.
- Installs new equipment and ensures that it operates correctly; train others to operate new machinery.
- Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies, and procedures.
- Responsible for communicating business related issues or opportunities to next management level.
- Responsible for ensuring subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition.
- Performs other duties assigned as
SUPERVISOR RESPONSIBILITIES:
The position does have supervisor responsibilities, is responsible for performance management and the hiring of the employees that are designated under their supervision.
QUALIFICATIONS:
- Bachelor's Degree in Mechanical Engineering, Biomedical Engineering, or related field is
- Master's Degree in Mechanical or Biomedical Engineering or related field is
- Must have one to five (1-5) years' relevant Engineering experience
- Knowledge and experience in catheter design is
- Experience with CAD software such as AutoCad or Solidworks is
- Knowledge and experience in development processes and in documentation writing is
- Experience with statistical analysis and design of experiments (DOE)
- Ability to use PC and associated software is
- In-depth knowledge of material and metals is
- Knowledge of Good Manufacturing Process and Good Documentation
COMPENTENCIES: To perform the job successfully, an individual should demonstrate the following competencies:
- Values: Integrity, Accountability, Teamwork, Innovation
- Excellent verbal and written communication skills
- Ability to work independently
- Ability to manage tight timelines and changing priorities
- Excellent problem -solving techniques
- Proficient with Microsoft office applications
- Skilled at providing technical leadership on cross-functional teams
PHYSICAL DEMANDS AND WORK ENVIRONMENT: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
PHYSICAL DEMANDS
- Physical Activity - Repetitive motions: Making substantial movements (motions) of the wrists, hands, and/or Fingering: Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling. Talking: Expressing or exchanging ideas by means of the spoken word.
- Physical Requirements - Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human Sedentary work involves sitting most
of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
- Visual Acuity - The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication of parts at distances close to the eyes.
WORK ENVIRONMENT
- Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work). The performance of this position may occasionally require exposure to the manufacturing areas, which may require the use of personal protective equipment such as, gloves, frocks, hair and beard covers, face protection, foot protection, safety glasses with side shields and mandatory hearing
TRAVEL:
This position may require 10-25% travel between sites and customer or supplier locations as required, dependent on the needs of the organization
Other Duties
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice
Job Posted by ApplicantPro
-
Process Development Engineer
6 days ago
Sunnyvale, California, United States HCLTech Full timeJob DescriptionJob Title: Process Development EngineerCompany: HCLTechJob Summary:We are seeking a highly skilled Process Development Engineer to join our team at HCLTech. As a Process Development Engineer, you will be responsible for collaborating with cross-functional teams to develop and implement innovative manufacturing processes.Key...
-
Process Engineer
4 weeks ago
Sunnyvale, United States EPITEC Full timeOverview:We are seeking a Process Engineer V to join our New Technology Validation Team, contributing to the development of cutting-edge active alignment technology for depth and camera modules. This role involves leading the innovation and refinement of processes and materials essential for camera and depth module projects, supporting a world-class...
-
Process Engineer
4 weeks ago
Sunnyvale, United States EPITEC Full timeOverview:We are seeking a Process Engineer V to join our New Technology Validation Team, contributing to the development of cutting-edge active alignment technology for depth and camera modules. This role involves leading the innovation and refinement of processes and materials essential for camera and depth module projects, supporting a world-class...
-
Process Engineer
6 days ago
Sunnyvale, United States HCLTech Full timeCollaborate with mechanical, manufacturing, process, and materials engineers to manage the development and documentation of innovative camera and depth module assembly processes• Design and execute life-cycle approach validation efforts to validate existing processes for the production of quality and conforming parts• Lead the overseas production of...
-
Process Engineer
3 weeks ago
Sunnyvale, United States HCLTech Full timeCollaborate with mechanical, manufacturing, process, and materials engineers to manage the development and documentation of innovative camera and depth module assembly processes• Design and execute life-cycle approach validation efforts to validate existing processes for the production of quality and conforming parts• Lead the overseas production of...
-
Manufacturing Engineer
1 month ago
Sunnyvale, United States Intuitive Surgical Full timeJob DescriptionPrimary Function of Position:This entry level manufacturing engineer will support multiple manufacturing lines for both mature and new instruments and accessories for the Ion platform. This engineer must be able to support existing manufacturing lines, recommend and implement improved manufacturing processes, and guide manufacturing line...
-
Manufacturing Engineer
1 month ago
Sunnyvale, California, United States Intuitive Surgical Full timeJob DescriptionPrimary Function of Position:This entry level manufacturing engineer will support multiple manufacturing lines for both mature and new instruments and accessories for the Ion platform. This engineer must be able to support existing manufacturing lines, recommend and implement improved manufacturing processes, and guide manufacturing line...
-
Senior Process Engineer
6 days ago
Sunnyvale, United States Intelliswift Software Full timeJob Title: Process Engineer VLocation: Onsite in Redmond, WA, or Sunnyvale, CADuration: 12 Months 7-10 Years Experience preferred Must-Have Skills Ability to track and organize documentation, experiment results, standard operating procedures (SOPs), work-in-progress (WIP) logsExperience scaling processes/process development/process improvement/process...
-
Senior Process Engineer
4 weeks ago
Sunnyvale, United States Intelliswift Software Full timeJob Title: Process Engineer VLocation: Onsite in Redmond, WA, or Sunnyvale, CADuration: 12 Months 7-10 Years Experience preferred Must-Have Skills Ability to track and organize documentation, experiment results, standard operating procedures (SOPs), work-in-progress (WIP) logsExperience scaling processes/process development/process improvement/process...
-
Manufacturing Process Optimization Leader
1 week ago
Sunnyvale, California, United States Intuitive Surgical Full timeJob DescriptionPrimary Function of Position:The Production Control Manager will be responsible for overseeing the planning process to reduce costs, streamline processes, and implement continuous improvement objectives. This position will work closely with the Senior Production Control Manager and Production Departments to achieve the highest levels of...
-
Mechanical Manufacturing Engineer
1 month ago
Sunnyvale, United States Intuitive Surgical Full timeJob DescriptionPrimary Function of PositionAt Intuitive, we believe that minimally invasive care is life-enhancing care. We are looking for team members with exceptional character who have the capacity to simplify complex problems and the energy to urgently deliver solutions to our patients. We use creative techniques to solve hard problems to achieve...
-
Senior Manufacturing Engineer
2 weeks ago
Sunnyvale, California, United States Pacific Defense Full timeJob Overview** Due to the classified nature of our work, U.S. citizenship is required. Candidates must be willing to obtain and maintain a DoD Security Clearance.Location: Sunnyvale, CA About Pacific DefensePacific Defense is a prominent innovator in advanced RF and electronics systems tailored for the U.S. Department of Defense and commercial sectors. Our...
-
Senior Manufacturing Engineer
2 weeks ago
Sunnyvale, California, United States Pacific Defense Full timeJob Overview** Due to the classified nature of our work, U.S. citizenship is required. Candidates must be willing to obtain and maintain a DoD Security Clearance.Location: Sunnyvale, CA About Pacific DefensePacific Defense is a prominent innovator in advanced RF and electronics systems tailored for the U.S. Department of Defense and commercial sectors. Our...
-
Senior Manufacturing Engineer
2 weeks ago
Sunnyvale, California, United States Pacific Defense Full timeJob Overview** U.S. citizenship is mandatory due to the classified nature of our operations. Candidates must be prepared to obtain and maintain a DoD Security Clearance.Location: Sunnyvale, CAAbout Pacific DefensePacific Defense is a premier innovator in the development of sophisticated RF and electronic systems tailored for the U.S. Department of Defense...
-
Manufacturing Engineer
2 months ago
Sunnyvale, United States Intuitive Surgical Full timeJob DescriptionPrimary Function of PositionAs a member of the manufacturing engineering team, you will work in a dynamic, fast paced, and challenging environment. You will be responsible for supporting production of Da Vinci Surgical Robotic systems by applying your knowledge of system engineering including software, and electromechanical assemblies to...
-
Mechanical Manufacturing Engineering Manager
3 days ago
Sunnyvale, Texas, United States Google Full timeAbout the RoleAs a Mechanical Manufacturing Engineering Manager in the Cloud Supply Chain Organization at Google, you will lead a team of highly competent Mechanical Manufacturing Engineering Experts to deliver Cloud Hardware to our customers.Key ResponsibilitiesLead a team of Mechanical Manufacturing Engineering Experts to design, develop, and implement...
-
Sr. Manufacturing Engineer
4 weeks ago
Sunnyvale, United States Pacific Defense Full timeJob DescriptionJob Description** Due to the classified nature of our work, U.S. citizenship is required. Candidates must be willing to obtain and maintain a DoD Security Clearance.Location: Sunnyvale, CA About UsPacific Defense is a leading developer of advanced RF and electronics systems for the U.S. Department of Defense and commercial customers. Our team...
-
Sr. Manufacturing Engineer
4 months ago
Sunnyvale, United States Pacific Defense Full timeJob DescriptionJob Description** Due to the classified nature of our work, U.S. citizenship is required. Candidates must be willing to obtain and maintain a DoD Security Clearance.Location: Sunnyvale, CA About UsPacific Defense is a leading developer of advanced RF and electronics systems for the U.S. Department of Defense and commercial customers. Our team...
-
Sr. Manufacturing Software Engineer
3 weeks ago
Sunnyvale, United States Intuitive Surgical Full timeJob DescriptionPrimary Function of PositionThe engineer in this position will play a key role on the Manufacturing Software Engineering team to enable the manufacture of new surgical robotic instruments and accessories. This engineer will develop the software and algorithms that assure each instrument’s kinematic performance and safety. The position will...
-
Senior Manufacturing Software Engineer
2 weeks ago
Sunnyvale, California, United States Intuitive Surgical Full timeAbout the RoleWe are seeking a highly skilled Senior Manufacturing Software Engineer to join our team at Intuitive Surgical. As a key member of our Manufacturing Software Engineering team, you will play a critical role in developing software systems that control machines to streamline our manufacturing process.Key ResponsibilitiesSoftware Development:...