All Skills Related to Product Development Technician

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Career Description

Product Development Technicians assist with the creation and production of medical devices (products for use in the medical sciences). The medical device field has a broad range of products, including coronary artery stents, orthopedic devices, dental products, surgical products and bone transplantation products.  Some of the larger companies create a variety of medical products.  Smaller companies may make only one or two products.  You can work at a company that doesn’t manufacture any products, but has a heavy research dynamic.  Working in medical devices usually means working in private

Skill Sort descending Skill Category Description Career Options
Analyze Data Data analysis

Use a data set to understand and draw conclusions about a sample.  The analysis may include graphing, statistics, and presenting work in tables.

cGMP manufacturing Regulations

cGMP stands for current Good Manufacturing Practices. GMPs apply to industries that produce pharmaceuticals, food, and beverages. The FDA publishes guidances to help companies understand how they view the regulations related to drug manufacturing. Since FDA's thinking evolves, it is important to know what about the current GMPS. People who manufacture drugs for human use are expected to understand and comply with current FDA guidelines related to Good Manufacturing Practices.

Clean room Clean room Demonstrate proper gowning and cleanroom behavior.
Compliance management Quality Understand and comply with the procedures and systems needed to comply with company standards.
Computer skills Computer

Use Microsoft Office programs such as Word, Excel, and PowerPoint.  Word or another writing program would be used to prepare technical documents and write reports. Excel is used to create spreadsheets, tables, and graphs, and for data analysis. PowerPoint is used to present results.

Database skills, inventory tracking, and the ability to use a Laboratory Information Management system are also common requirements.

Data management Data management

Ensure that manufacturing data is maintained, reviewed, analyzed, assessed, ensuring accuracy and compliance

Documentation Documentation

Promptly and accurately enter information, calculate, and report results.

Electronic Laboratory Notebook Documentation Use an electronic laboratory notebook for recording and reporting results.
Electronics Instrumentation

Be able to repair small electronics. Understand current, voltage, and power.

Emergency procedures Workplace behavior

Know what to do when there is an emergency.  This would include CPR and basic first aid.

Environmental Health and Safety Safety Understand and comply with environmental health and safety rules to prevent injuries, protect the environment, and prevent pollution.
Good Manufacturing Practices (GMPs) Regulations

Companies that manufacture substances regulated by the FDA must adhere to Good Manufacturing Practices (GMPs). Good Documentation Practices (GDP) are important in recording and managing data related to test results.

Inventory Laboratory Operations

Review, document, maintain, and order laboratory supplies. Record information.

Laboratory Information Management Systems (LIMS) Data management Understand the purpose of a LIMS and be able to use one.
Laboratory Safety Safety Know how to find MSDS information and follow proper laboratory safety protocols
Manufacturing operations Manufacturing Understand the steps involved in manufacturing and delivering a product that meets the required specifications.
Math Math

Perform mathematical calculations, including addition, subtraction, division, multiplication, ratios, and percentages. Must be able to use proportions, understand orders of magnitude, convert units, and use dimensional analysis.

Oral communication Communication Able to convey information accurately orally
Project Management Workplace behavior Project managers identify components of a project, develop timelines, and work with a team to assign tasks and follow up on progress.
Project timelines Project management Understand project timelines, start-up and changeover schedules
Quality Control Quality Understand quality systems and documentation
Regulatory Agencies Biotechnology Demonstrate knowledge of regulatory agencies governing the manufacture and distribution of biotechnology-derived products
Safety Compliance Safety

Carry out laboratory work and field work without endangering yourself or others.

Spreadsheets Computer Use Microsoft Excel to create tables, graph data, and carry out calculations
Standard Operating Procedures (SOPs) Biotechnology Follow SOPs and adhere to quality guidelines.
Team work Communication Work effectively with team members to coordinate tasks and meet objectives
Technical writing Communication

Know how to write, revise, and collaborate on technical documents such as standard operating procedures (SOPs) and analytical methods.

Time management Workplace behavior

Accurately estimate the amount of time needed to perform one or more tasks and organize time effectively.

Troubleshooting Laboratory Operations

Analyze a problem and identify the correct solution

U.S. Food and Drug Administration (FDA) Regulations

The FDA protects public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of the U.Ss food supply, cosmetics, and products that emit radiation. They also regulate tobacco.

Many biotechnology companies require employees to understand and know how to comply with FDA requirements. These include for Good Laboratory Practices (GLPs), Good Manufacturing Practices (GMPs), and Good Documentation Practices (GDPs). Companies that are carrying out clinical trials must also comply with Good Clinical Practices (GCPs).

Written communication Communication Able to convey information accurately through writing