Medical Device Job Description (2023)

Medical DeviceJob Description

To supervise the production personnel within the production area by administering company policies and procedures

Evaluate current processes & procedures and implement new and necessary improvements and additions

Conduct project activities within the framework of the group’s ISO 13485 Quality System

Follow ASD Quality procedures

Works with Value Stream and Quality Engineering Manager to deliver business objectives, lean manufacturing metrics, VIP, cycle time, scrap as %VOP

Responsible for the departmental basics including budgeting, hiring, day-to-day Management, project resourcing

Month-end closing and support for statutory, tax and internal audits

Fixed Asset and depreciation

Lead Accounts Payable and Accounts Receivable transactions

Assisting in year end activities and analysis of financial reports

Key user in SAP and take part in process improvement projects

Product Standard Cost and other Costing related activities such as Cost Structure Development Analysis and Base Cost Analysis

Support budgeting processes, annual stock take and cost roll

Perform weekly cycle count, scrap process, monthly reconciliation of inventory and ongoing item reclassification analysis

Involve in process improvement projects

3-5 years of software development experience with 1+ years in C++ and VB+, Microsoft Certified will be highly desirable

Our innovative and growing company is hiring for a medical device. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.

Responsibilities for medical device

• Build an efficient organization that supports pre-market, post-market and regulatory operations for LSAG medical device products
• Manage all aspects of the Medical Device Regulations (QSR, IVDD, …) for LSAG medical device products and own the resulting responsibilities in LSAG (incl
• Provide expert guidance and education to LSAG organization
• Monitor global regulatory changes and assure continuous compliance for LSAG medical device products and processes
• Manage facility inspections and audits from regulatory authorities and certification bodies in close cooperation with the Agilent Enterprise RA/QA function
• Lead proposal efforts, in collaboration with internal team and client, to define an overall approach, schedule, and cost that represents an acceptable benefit to the client
• Facilitate detailed project planning, including all elements of scope, cost, schedule, risk and technical performance deliverables, to fully define the project through completion
• Manage internal team project performance by proactively balancing the triple-constraint of scope, cost, and schedule, leading to a successful conclusion
• Serve as the primary client contact throughout the project execution, providing periodic assessments of project performance against plan, raising and executing needed risk mitigations
• Provide technical support and oversight throughout the execution of the project

Qualifications for medical device

• Must have worked in Microsoft Windows application development
• Hands-on experience with MS tools and technologies such as Visual Studio, TFS
• Preferred with a working knowledge on Microsoft Windows Embedded
• Very good knowledge on general computer software and network systems
• Knowledge of communication standards ASTM, HL7, POCT1-A
• Knowledge of Mirth

Our company is hiring for a medical device. If you are looking for an exciting place to work, please take a look at the list of qualifications below.

Responsibilities for medical device

• Comply with safety and housekeeping procedures and standards
• Maintain GMP systems, including pre-production quality assurance procedures, pre-clinical testing programs, and post-production GMP compliance in coordination with the Document Control, Clinical, and Quality Assurance functions
• Prepare and present periodic project performance updates to internal management
• Stay abreast of Project Management best practices and share key learning with project management and project team staff
• Understand, embrace and ensure compliance to relevant Quality Systems and applicable government and industry regulations
• Handle quality system programs including
• Work with R&D scientists, engineers, managers and technical experts to develop, and implement design history file documents in the standard formats
• Maintain a SharePoint document library as needed
• Generate status reporting and presentation content as needed
• Collaborate across a global organization

Qualifications for medical device

• Able to work with a minimum of supervision, prioritizes and executes complex tasks in a multitasking environment
• Experience with data and statistical analysis (JMP, Minitab), DOE, and measurement system analysis
• Bachelor’s Degree in Engineering or a business management field from an accredited institution and a minimum of 5 years of product development experience, at least 3 of which is in medical devices
• A minimum of 3 years of product development experience in a project management role
• Demonstrated interpersonal and project management skills with ability to work collaboratively with both internal and external counterparts
• Demonstrated ability to give presentations and communicate effectively with internal and external clients

Our company is hiring for a medical device. If you are looking for an exciting place to work, please take a look at the list of qualifications below.

Responsibilities for medical device

• This position requires excellent organization skills, the ability to multi-task and prioritize various types of work and be able to meet/set deadlines for all assigned work
• ACCOUNTABILITY/DECISION MAKING
• The individual will be motivated with the ability to be self-directed and work well independently in support of a Project team
• Ensure complete, accurate and timely reporting of MDR/vigilance data as required by regulatory agencies
• Provide input on internal system and methods to maintain MDR/vigilance compliance and support post-market surveillance
• Develop SOPs and guidance documents to assist other staff with device field event evaluation
• Participate in the development of the electrical system within diagnostic instrumentation to the agreed upon technical project goals with guidance from the Senior Manager of Systems Engineering
• Work with sources external to the company to identify and implement applicable systems, system components and/or technologies
• Produce documentation for each development phase of sufficient scope and detail to understand the theory of operation of the system and be able to support and reproduce the hardware
• Provide supervisor with information of daily, weekly, and monthly activities and schedules to keep him/her aware of the progress on each project

Qualifications for medical device

• Proficient use of Microsoft Office, Project, Excel, and other standard programs for project, business and financial management
• Experience working within medical device development Quality Systems
• Must have strong design skills in single use plastic and/or metal disposable products with at least 3-5 years’ experience using SOLIDWORKS or PRO E
• Ability to Support/Lead new product development activities including conceptualization and design controls (design verification, validation, process validation )
• Highly desirable to have experience in mechanical test systems such as Instron for measuring forces, speed, and pressure
• Analyze process and products and implement enhanced quality systems enhancements

Our company is growing rapidly and is looking to fill the role of medical device. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.

Responsibilities for medical device

• Electronically process events to determine complaint and reportability status
• Assist in inspection support for FDA and global regulatory agencies
• Provides project and product managers support and assistance in planning, documenting, communicating, and executing sustainability and maintenance activities aimed at long term compliance and optimization of existing medical devices
• Facilitates change requests, project planning/execution, document updates, and procedural implementation of initiatives assigned
• Conduct engineering testing
• Build prototypes and test samples
• Effectively use engineering tools, such as 3D modeling, statistical software and FEA in their daily work
• Take responsible for multi-disciplinary project teams and be capable of managing multiple projects simultaneously
• Conduct independent engineering analysis
• Originate, update and edit engineering drawings, work instructions, protocols, reports and specifications

Qualifications for medical device

• 18 Years or Older (Cannot operate vehicles that exceed 10,000 lbs
• Bachelors in Engineering or Bachelor’s degree in another concentration with a combination of education and professional experience
• Experience in quality assurance and compliance, manufacturing and/or development, working with consumer and/or pharmaceutical products
• Proven record of supporting of quality operations business objectives
• General knowledge of regulatory compliance requirements, including medical devices
• Experience with QMS documentation processes required for product release, complaint management and coordination of formal agreements

Our growing company is hiring for a medical device. If you are looking for an exciting place to work, please take a look at the list of qualifications below.

Responsibilities for medical device

• Support and lead the creation of intellectual property
• Act as the technical contact with outside suppliers for custom components
• Visualize, create and implement department and cross-department systems that improve efficiency and effectiveness
• Actively mentor and train other engineers
• Working within the team to write, test, debug and peer review code for the
• Setting up Electrical equipment to run diagnostic and reliability tests
• Documenting data into Excel and other computer programs
• Ability to operate a stop watch
• Follow written instruction and verbal instruction
• Procure products by establishing MOQ, safety stock and lead time

Qualifications for medical device

• Good knowledge of Regulatory and ISO Quality management system standards
• Good supply chain (rather than functional) thinking
• Broad network within CH Business
• Minimum of 1 year experience in a QA setting
• Previous experience with complaint handling for Medical devices
• Proven ability to work under pressure and facilitate conversations with suppliers