Current Openings

Starting Pay

$18.00/hour

Essential Responsibilities

• Sizing product by processing it with die cutters and powder milling equipment
• Packaging product into sterile barrier packaging including filling jars, tubes, and pouches
• Sealing pouches, labeling pouches, assembly into boxes and labeling boxes
• Printing product labels using barcode label software and a label printer
• Performing measurements of length, thickness, mass, volume, torque, and pH
• Mixing both dry and liquid chemicals as directed by standard work instructions
• Documenting work performed in batch records as directed by standard work instructions
• Collecting samples of products for quality assurance purposes
• Setup, operation, monitoring, and teardown of mixing equipment, filling equipment, cutting presses, milling equipment, heat sealers, and other packaging equipment
• Cleaning and disinfecting equipment and supplies used in the manufacture of product
• Comply with FDA Good Manufacturing Practices and Good Documentation Practices
• Promote and enforce a safe working environment by adhering to OSHA regulations and company safety policies

Additional Responsibilities

• Regular cleaning and disinfection of the cleanroom areas
• Picking raw materials from inventory locations
• Identifying raw material shortages and issues
• Identify, label, and properly store hazardous waste

Required Qualifications

• High School diploma or GED
• Ability to count and perform basic math calculations (addition, subtraction, greater-than/less-than scenarios)
• Ability to add, subtract, and evaluate time in 24-hour (military) format
• Good verbal communication skills
• Legible handwriting for recording data in manufacturing records
• Proficient reading, analysis and interpretation of business documents, technical procedures, and government regulations in English
• Ability to effectively present information and respond to questions from managers, clients, and customers

Preferred Qualifications

• 2-year technology degree in biotechnology or another scientific field
• Experience working in a cleanroom environment
• Experience in medical device or pharmaceutical industry with Good Manufacturing Practices (GMP)
• Experience measuring length, thickness, mass, volume, and pH
• Familiarity with FDA regulations, ISO standards, and Quality Management Systems

Work Environment

Most time will be spent in an air-conditioned cleanroom environment with some time in the warehouse. Work performed in both sitting and standing positions. Cleanroom requires designated gowning and standard anti-contamination practices.

Physical Requirements

• Bending, lifting, pulling, pushing, and standing for long periods of time
• Manual dexterity for measurement, assembly, and documentation activities
• Ability to move containers and boxes weighing up to 50 pounds occasionally
• Cleaning (mopping and wiping) of cleanrooms and equipment

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Job Summary

In this role, the individual is primarily responsible for performing activities in support of the development and manufacture of tissue and polymer based medical devices based on proven scientific concepts.

Responsibilities and Duties

• Interpret customer and market needs into documented product requirements
• Refine product and process characteristics through research and experimentation
• Evaluate product risks using traditional methods and implement control mechanisms to reduce risks to acceptable levels
• Create product specifications, raw material specifications, and manufacturing procedures
• Demonstrate the ability of products to meet requirements through verification and validation testing
• Become familiar with and follow design control procedures according to FDA and ISO requirements
• Plan and manage project work in accordance with defined deliverable targets
• Support regulatory product submissions through testing and documentation
• Specify materials and equipment required to achieve objectives
• Identify and direct work with outside strategic partners as required
• Research scientific and clinical publications to support methods or conclusions
• Generate technical reports, making data-based recommendations for the products
• CAD design of product, tooling and fixtures as required
• Comply with regulatory guidelines for design control

Required Qualifications

• Bachelor’s degree in Engineering or a related field
• Strong written and verbal communication skills, with the ability to work closely with both internal and external team members
• Proficient in the use of personal computers, including Microsoft Outlook, Microsoft Word and Microsoft Excel
• The ability to make necessary decisions and/or take action required to carry out job duties
• The ability to operate independently and to self-manage all activities in working towards the common goals of the organization
• Proficient reading, analysis and interpretation of business documents, professional journals, technical procedures, and government regulations in English
• Ability to effectively present information and respond to questions from managers, clients, customers, and the general public in English

Preferred Qualifications

• Undergraduate experience with tissue engineering and/or polymer science
• Prior experience with medical devices
• Experience working in cleanroom environments

Work Environment

The individual will split time between a typical office environment and the manufacturing area, which consists of a mix of cleanroom and lab-style manufacturing spaces. When in the cleanroom, the individual will be expected to wear designated gowning and follow standard anti-contamination practices. All areas are environmentally controlled.

Physical Requirements

• Standard office work, which involves writing, typing, filing and other work performed at a desk or in a normal office environment
• Lab and manufacturing work, which involves taking measurements using hand-held and large computer-controlled tools
• Measuring and mixing chemicals, and operating large pieces of laboratory and manufacturing equipment

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