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

Apply Now

Essential Duties and Responsibilities

• Design, develop, validate, scale, and continuously improve manufacturing processes for extracellular matrix (ECM), natural polymer, and other biomedical products.
• Identify and implement opportunities to improve throughput, product quality, process consistency, capacity utilization, and cost performance through the application of Lean Manufacturing, Six Sigma, and other continuous improvement methodologies.
• Lead the transfer of new products and processes from R&D into pilot and commercial manufacturing, ensuring robust and sustainable production methods.
• Develop and maintain manufacturing procedures, work instructions, process specifications, batch records, and other production documentation required for controlled manufacturing operations.
• Specify, justify, procure, install, qualify, and optimize manufacturing equipment, tooling, fixtures, automation systems, and production technologies.
• Develop and execute equipment qualification and process validation activities, including IQ, OQ, PQ, DOE, process capability studies, SPC, and other statistical methods.
• Evaluate, implement, and support ERP/MRP, MES, electronic batch records, automation, and data collection systems to improve planning, traceability, operational efficiency, and manufacturing performance.
• Analyze production workflows, labor utilization, equipment performance, and material flow to identify and eliminate bottlenecks, reduce waste, and improve operational effectiveness.
• Investigate process deviations, identify root causes, and implement effective corrective and preventive actions (CAPA).
• Ensure manufacturing processes comply with FDA Quality System Regulations, ISO 13485 requirements, design control requirements, and internal quality procedures.
• Support risk management, supplier qualification, change control, and other quality system activities related to manufacturing processes.
• Collaborate with Manufacturing, Quality, Supply Chain, R&D, Project Engineering, and external partners to implement solutions that improve product quality, manufacturing performance, and business results.
• Lead cross-functional engineering projects, including the development of project plans, budgets, timelines, and resource requirements, to ensure successful implementation of manufacturing improvements and new technologies.

Non-Essential Duties and Responsibilities

• Develop and maintain manufacturing performance metrics and dashboards, including yield, cycle time, labor efficiency, capacity utilization, scrap rates, and on-time KPI reporting.
• Research emerging technologies, scientific literature, and industry best practices to identify opportunities for process innovation and operational improvement.
• Provide training and technical guidance to manufacturing personnel on new processes, equipment, and systems.
• Support special projects and continuous improvement initiatives as assigned by management.

Required Qualifications

• 3-years of relevant professional (non-internship or co-op) experience with a Bachelor’s degree in Engineering, or 2-years of relevant professional experience with an advanced degree.
• 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 the use of 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.

Preferred Qualifications

• Degree in Biomedical, Chemical, Polymer, Mechanical, or Industrial Engineering.
• Prior experience with medical device development and/or manufacturing.
• Prior experience with tissue engineering and/or polymer science.
• Experience working in cleanroom environments.
• Experience with process validation
• Experience with lyophilization processes
• Experience with statistical techniques
• Experience with project management

.

Language Skills

Candidate must have the ability to proficiently read, analyze and interpret general business periodicals, professional journals, technical procedures, and government regulations written in the English language. Must also be able to effectively present information and respond to questions from groups of managers, clients, customers, and the general public in the English language.

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

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.

Apply Now