OriGen Biomedical Open Jobs

POSITION SUMMARY

The Customer Service Representative I serves as the primary point of contact for customers, delivering prompt, professional, and courteous service through phone and email communications. As the customer’s first impression of OriGen Biomedical, this role is responsible for creating a positive experience while ensuring inquiries are handled accurately and efficiently. The candidate is expected to develop a thorough understanding of OriGen Biomedical’s product portfolio to confidently and efficiently respond to level one technical inquiries and support customer needs.

ESSENTIAL DUTIES AND RESPONSIBILITIES

The essential duties and responsibilities of this position include, but are not limited to the following:

• Create new customer accounts per established approval processes and procedures.
• Serve as the first contact for incoming Customer Service queue calls, provide timely assistance, and ensure customer inquiries are addressed or appropriately routed.
• Demonstrate a friendly, professional, and courteous communication style, with the ability to create a positive customer experience over the phone.
• Process customer phone orders, ensuring all order details are complete, correct, and completed within established procedures.
• Enter and process all customer orders received via email and electronic fax into the ERP system, verifying order details for completeness and accuracy.
• Confirm customer orders via email, providing accurate order details, estimated ship dates, and any additional information needed to ensure clear communication.
• Coordinate with Production to verify lead times for products requiring confirmation and communicate updates accurately and promptly to customers and Account Managers.
• Support customers with return requests and coordinate with the Account Manager and Finance team to facilitate the processing of credit notes or refunds as needed.
• Assist customers with verbal quote requests received by phone and ensure all formal written quote requests are forwarded to the assigned Account Manager for timely response.
• Process and ship sample product to both domestic and international customers.
• Cross-train with Logistics to gain knowledge of customer shipment processes and provide support with shipping-related tasks as needed or assigned.
• Other duties as assigned.

REQUIRED SKILLSETS

• Good organizational skills, attention to detail, and follow-through are essential to meeting customer expectations, supporting departmental objectives, and contributing to our overall business success.
• Proficient in computer systems and standard business software applications, including Microsoft Word, Excel, and Google Workspace. Experience with ERP systems is preferred but not required.
• Excellent written and verbal communication skills, with the ability to communicate effectively with customers, Production Management, Production Technicians, Engineers, and senior leadership.
• Must be able to read, write, speak, and fully understand English

COMPETENCIES

• Customer Focus & Empathy
• Commitment to Excellence & Results
• Ownership & Accountability
• Technical Aptitude & Curiosity
• Integrity & Professionalism
• Critical Thinking & Problem Solving
• Attention to Detail
• Interpersonal Skills & Collaboration
• Adaptability & Flexibility
• Learning Agility & Growth Mindset

MINIMUM QUALIFICATIONS (KNOWLEDGE, SKILLS, & ABILITIES)

• High school diploma or equivalent.
• Minimum of one to two years of customer service or equivalent experience.
• Ability to understand, interpret, and respond appropriately to customer needs.
• Strong interpersonal skills, including the ability to build positive relationships with customers and internal teams.
• Reliable organizational and time management skills with the ability to prioritize tasks, manage multiple responsibilities, and meet deadlines.
• Excellent verbal and written communication skills.
• Strong attention to detail and commitment to accuracy.
• Ability to work independently while also collaborating effectively within a team environment.
• Ability to manage assigned projects and responsibilities from initiation through completion.

PREFERRED QUALIFICATIONS

• Two or more years of customer service, related, or equivalent experience.
• Experience managing customer accounts and inquiries in an environment that emphasizes quality of
• service, responsiveness, and relationship management over high-volume transaction handling.
• Experience working within the medical device, life sciences, healthcare, or regulated industry environment.
• Experience using ERP systems or other business management software.

SUPERVISORY RESPONSIBILITY

This position has no direct supervisory responsibilities. However, the individual may be responsible for coordinating assigned projects, collaborating with cross-functional teams, and supporting completion of activities within established timelines.

WORK ENVIRONMENT

This job operates in a professional office environment. This role routinely uses standard office equipment, including computers, phones, photocopiers, filing cabinets, and fax machines. Must be able to stand or sit for extended periods. Must be able to wear personal protective equipment when required.

PHYSICAL DEMANDS & WORK ENVIRONMENT

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential job duties and responsibilities of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.

While performing the duties of this position, the employee is regularly required to talk and hear. The employee is frequently required to use hands, fingers, handle, or feel objects, tools, or controls. The employee is occasionally required to stand, walk, sit, and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, color vision, and the ability to adjust focus. The noise level in the work environment is usually moderate.

NOTE

This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employees will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorized to give instructions or assignments. All duties and responsibilities are essential functions and requirements and are subject to possible modification to reasonably accommodate individuals with disabilities.

To perform this job successfully, the incumbents will possess the skills, aptitudes, and abilities to perform each duty proficiently. Some requirements may exclude individuals who pose a direct threat or significant risk to the health or safety of themselves or others. The requirements listed in this document are the minimum levels of knowledge, skills, or abilities. This document does not create an employment contract, implied or otherwise, other than an “at-will” relationship.

POSITION SUMMARY

The Sustaining Engineer level I will support on-market Class I and Class II disposable, sterile medical devices with

technical support, product training, improved processes, contingency planning, and implementation of cost savings

initiatives. The sustaining engineer will assist both manufacturing and development engineers to maintain our on-

market devices.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• The essential duties and responsibilities of this position include, but are not limited to the following:
• Draft and execute test protocols to demonstrate product capabilities that meet customer needs.
• Manage the design history files of on-market devices and keep to state-of-the-art standards.
• Consult with marketing and regulatory to identify new markets for devices and plan new validation and testing activities as necessary.
• Assess risk to the design, manufacturing process, and use of on-market devices.
• Execute risk mitigation activities to reduce risk to patients as far as possible and document to current standards.
• Assist in complaint and discrepant material investigations with good documentation and reporting.
• Create supply-chain contingency plans for critical raw material components of on-market devices.
• Assist Development Engineering with variant development projects of on-market devices including preparation of cost estimations, drawings, and samples.
• Provide product technical support to account managers and customer service.
• Train manufacturing technicians and quality inspectors to the use of products.
• Establish and maintain standards for released drawings and material specifications.
• Review revisions to Standard Operating Procedures and manufacturing instructions.
• Evaluate and document process risks that tie into validation.
• Perform Root Cause Analysis of product-related problems, plan, and implement corrective actions.
• Other duties and/or projects as assigned

REQUIRED SKILLSETS

Knowledge of FDA regulations and GMP guidelines for medical device validation.

Proven skills in coordinating and managing day to day tasks and working in collaboration to accomplish

deadlines and objectives.

Proficiency in technical and layman writing.

Works in cross functional teams to complete projects and testing.

Knowledge of and skills in using computer software and hardware applications, including Microsoft Word,

CAD, and Excel.

Outstanding communication skills, both written and oral, and will be expected to communicate directly with

production management, production technicians, engineers, and senior management.

COMPETENCIES

• Self-motivated
• Broad creativity and curiosity
• Problem-solving skills
• Computer Aided Design software (e.g. SolidWorks)
• Project Management
• Ethical Conduct
• Communication and interpersonal skills
• Strategic Thought
• Adaptability
• DOE and Validation testing
• Decision making
• Corrective and preventative actions

MINIMUM QUALIFICATIONS (KNOWLEDGE, SKILLS, & ABILITIES)

• Bachelor’s degree in Engineering OR 4+ years’ experience in engineering principals of medical devices /ISO 13485 environment
• Demonstrated ability to use effective and results-oriented problem solving and critical thinking skills; strong troubleshoot ability
• Strong interpersonal and people skills
• Strong organization and time management skills with the demonstrated ability to meet deadlines
• Strong and effective communication skills (verbal and written)
• Close attention to detail
• Ability to work independently and lead or participate in a cross-functional team environment

PREFERRED QUALIFICATIONS

• ISO 13485 experience

SUPERVISORY RESPONSIBILITY

This position has no supervisory responsibilities. This position may be required to lead/report on projects and

ensure participants meet deadlines.

WORK ENVIRONMENT

This job operates in a climate-controlled warehouse and/or professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets, and fax machines. The noise level in the work environment is generally moderate however periods of higher-level noise may occur. This job may also operate in a cleanroom environment. The cleanroom environment requires personnel to wear personal clothing completely covering the legs; company-provided cleanroom attire; e.g. coat, bouffant, face mask, and gloves.

• Must be able to stand or sit for extended periods. Must be able to wear personal protective equipment when required

PHYSICAL DEMANDS & WORK ENVIRONMENT

The physical demands described here are representative of those that must be met by an employee to successfully

perform the essential job duties and responsibilities of this position. Reasonable accommodations may be made to

enable individuals with disabilities to perform the functions.

While performing the duties of this position, the employee is regularly required to talk and hear. The employee is

frequently required to use hands, fingers, handle or feel objects, tools, or controls. The employee is frequently

required to stand, walk, climb, sit, stoop, bend, and reach with hands and arms. The employee must frequently lift

and/or move up to 50 pounds and may be required to operate automated warehouse equipment; e.g. electric pallet

jack, or forklift. Specific vision abilities required by this position include close vision, distance vision, color vision,

and the ability to adjust focus.

NOTE

This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employees will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorized to give instructions or assignments. All duties and responsibilities are essential functions and requirements and are subject to possible modification to reasonably accommodate individuals with disabilities. To perform this job successfully, the incumbents will possess the skills, aptitudes, and abilities to perform each duty proficiently. Some requirements may exclude individuals who pose a direct threat or significant risk to the health or safety of themselves or others. The requirements listed in this document are the minimum levels of knowledge, skills, or abilities. This document does not create an employment contract, implied or otherwise, other than an “at-will” relationship.

POSITION SUMMARY

The Cleanroom Line Lead is responsible for leading and directing the CR team in assembly, testing and packaging of medical devices and components.   Role is required to understand and comply with drawings, written procedures, batch records and apply these standards to their work.

As a team lead, you will be the main contact point for all team members. You will possess the ability to be a team player, team leader and are expected to timely escalate issues to management for resolution. You should lead by setting a good example and engage and motivate the team to achieve daily goals.   You will oversee production processes in accordance with OriGen’s policies and procedures.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• The essential duties and responsibilities of this position include, but are not limited to the following:
• Daily CR Shift Setup:
• Equipment inspection and start-up
• Daily log review/completion
• Priority assessment and assignment
• Shift pass down – verify all paperwork is filled out before passing on
• Report problems or concerns with quality, processes, equipment, materials and staffing to Operations Manager or designee
• Meet production schedules and deadlines while maintaining quality standards
• Work in a flexible and changing environment
• Communicate, delegate and motivate in a positive manner
• Lead and motivate team members to meet production goals
• Follow detailed written and verbal instructions
• Aid in training members on assembly processes and answers related questions from team
• Effectively communicate daily concerns and issues with others and management during shift and at shift change
• Learn multiple tasks and train in other areas as needed
• Work with a variety of tools and equipment
• Maintain all logs, paperwork and forms accurately
• Understand, access and make entries to documents on the company Electronic Document System
• Accurately perform job duties with minimum supervision
• Adhere to cleanroom dress code and policies
• Work in a multi-cultural team environment and be a team player
• Work in a cleanroom environment for extended periods of time
• Must be punctual, reliable and willing to lead by example

REQUIRED SKILLSETS

• Detailed oriented and able to focus on repetitive tasks for long periods of time
• Proficient on computer; possessing basic navigation and program knowledge
• Able to absorb, assimilate and accurately recall/locate and retain large quantities of data/information
• Must be able to read, write, speak and fully understand English

COMPETENCIES

• Adaptability/Flexibility
• Ethical Conduct/Integrity
• Communication/Listening
• Detail-Oriented
• Interpersonal skills
• Personal Effectiveness
• Teamwork/Team Leadership

MINIMUM QUALIFICATIONS (KNOWLEDGE, SKILLS, & ABILITIES)

• Basic computer navigation and program knowledge
• Strong organization and time management skills with the demonstrated ability to meet deadlines
• Close attention to detail
• Ability to work independently and within a team environment
• Prior Clean Room experience

PREFERRED QUALIFICATIONS

• Prior experience in a lead position is preferred

SUPERVISORY RESPONSIBILITY

This position has no direct supervisory responsibilities although the role will be responsible for daily work/task assignment and oversight.

WORK ENVIRONMENT

This job often operates in a cleanroom environment. Cleanroom environment requires personnel to wear personal clean and non-frayed pants/scrubs completely covering the legs and/or a full pants/body “bunny suit”.  Personnel may also be required to wear company-provided cleanroom coat, bouffant, face mask, and gloves.

• Must be able to stand or sit for extended periods of time. Must be able to wear personal protective equipment when required.
• Due to extremely detailed nature of work, may be required to submit to periodic post-employment vision screening and be willing/able to wear corrective eye wear if deemed necessary/appropriate.
• Note:  OriGen is a fragrance, smoke, smokeless tobacco and vape-free facility.  There is NO use of any tobacco or vape products permitted anywhere on company grounds/property or during any shift, break or lunch period. 

PHYSICAL DEMANDS & WORK ENVIRONMENT

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential job duties and responsibilities of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.

While performing the duties of this position, the employee is regularly required to talk and hear. The employee is frequently required to use hands, fingers, handle or feel objects, tools, or controls. The employee is frequently required to stand; walk; sit; and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, color vision, and the ability to adjust focus.The noise level in the work environment is usually moderate.

NOTE

This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employees will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorized to give instructions or assignments. All duties and responsibilities are essential functions and requirements and are subject to possible modification to reasonably accommodate individuals with disabilities. To perform this job successfully, the incumbents will possess the skills, aptitudes, and abilities to perform each duty proficiently. Some requirements may exclude individuals who pose a direct threat or significant risk to the health or safety of themselves or others. The requirements listed in this document are the minimum levels of knowledge, skills, or abilities. This document does not create an employment contract, implied or otherwise, other than an “at-will” relationship.

POSITION SUMMARY

The Cleanroom Line Lead is responsible for leading and directing the CR team in assembly, testing and packaging of medical devices and components.   Role is required to understand and comply with drawings, written procedures, batch records and apply these standards to their work.

As a team lead, you will be the main contact point for all team members. You will possess the ability to be a team player, team leader and are expected to timely escalate issues to management for resolution. You should lead by setting a good example and engage and motivate the team to achieve daily goals.   You will oversee production processes in accordance with OriGen’s policies and procedures.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• The essential duties and responsibilities of this position include, but are not limited to the following:
• Daily CR Shift Setup:
• Equipment inspection and start-up
• Daily log review/completion
• Priority assessment and assignment
• Shift pass down – verify all paperwork is filled out before passing on
• Report problems or concerns with quality, processes, equipment, materials and staffing to Operations Manager or designee
• Meet production schedules and deadlines while maintaining quality standards
• Work in a flexible and changing environment
• Communicate, delegate and motivate in a positive manner
• Lead and motivate team members to meet production goals
• Follow detailed written and verbal instructions
• Aid in training members on assembly processes and answers related questions from team
• Effectively communicate daily concerns and issues with others and management during shift and at shift change
• Learn multiple tasks and train in other areas as needed
• Work with a variety of tools and equipment
• Maintain all logs, paperwork and forms accurately
• Understand, access and make entries to documents on the company Electronic Document System
• Accurately perform job duties with minimum supervision
• Adhere to cleanroom dress code and policies
• Work in a multi-cultural team environment and be a team player
• Work in a cleanroom environment for extended periods of time
• Must be punctual, reliable and willing to lead by example

REQUIRED SKILLSETS

• Detailed oriented and able to focus on repetitive tasks for long periods of time
• Proficient on computer; possessing basic navigation and program knowledge
• Able to absorb, assimilate and accurately recall/locate and retain large quantities of data/information
• Must be able to read, write, speak and fully understand English

COMPETENCIES

• Adaptability/Flexibility
• Ethical Conduct/Integrity
• Communication/Listening
• Detail-Oriented
• Interpersonal skills
• Personal Effectiveness
• Teamwork/Team Leadership

MINIMUM QUALIFICATIONS (KNOWLEDGE, SKILLS, & ABILITIES)

• Basic computer navigation and program knowledge
• Strong organization and time management skills with the demonstrated ability to meet deadlines
• Close attention to detail
• Ability to work independently and within a team environment
• Prior Clean Room experience

PREFERRED QUALIFICATIONS

• Prior experience in a lead position is preferred

SUPERVISORY RESPONSIBILITY

This position has no direct supervisory responsibilities although the role will be responsible for daily work/task assignment and oversight.

WORK ENVIRONMENT

This job often operates in a cleanroom environment. Cleanroom environment requires personnel to wear personal clean and non-frayed pants/scrubs completely covering the legs and/or a full pants/body “bunny suit”.  Personnel may also be required to wear company-provided cleanroom coat, bouffant, face mask, and gloves.

• Must be able to stand or sit for extended periods of time. Must be able to wear personal protective equipment when required.
• Due to extremely detailed nature of work, may be required to submit to periodic post-employment vision screening and be willing/able to wear corrective eye wear if deemed necessary/appropriate.
• Note:  OriGen is a fragrance, smoke, smokeless tobacco and vape-free facility.  There is NO use of any tobacco or vape products permitted anywhere on company grounds/property or during any shift, break or lunch period. 

PHYSICAL DEMANDS & WORK ENVIRONMENT

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential job duties and responsibilities of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.

While performing the duties of this position, the employee is regularly required to talk and hear. The employee is frequently required to use hands, fingers, handle or feel objects, tools, or controls. The employee is frequently required to stand; walk; sit; and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, color vision, and the ability to adjust focus.The noise level in the work environment is usually moderate.

NOTE

This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employees will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorized to give instructions or assignments. All duties and responsibilities are essential functions and requirements and are subject to possible modification to reasonably accommodate individuals with disabilities. To perform this job successfully, the incumbents will possess the skills, aptitudes, and abilities to perform each duty proficiently. Some requirements may exclude individuals who pose a direct threat or significant risk to the health or safety of themselves or others. The requirements listed in this document are the minimum levels of knowledge, skills, or abilities. This document does not create an employment contract, implied or otherwise, other than an “at-will” relationship.

Morning Shift: Work hours: five days, 8-hour shifts (Monday-Friday 5:30am – 2:00pm).

Evening Shift: Work hours: four days, 10-hour shifts (Monday-Thursday  2:15pm – 12:45am). 

The Clean Room Tech (CRT) is responsible for the assembly, testing, and packaging of medical devices and components. Required to understand and comply with drawings, written procedures, batch records, and must apply these standards to their work.

Essential Duties and Responsibilities

The essential duties and responsibilities of this position include, but are not limited to the following:

• Ability to meet production schedules and deadlines according to quality standards
• Ability to work in a flexible and changing environment
• Ability to follow detailed written and verbal instructions
• Ability to learn multiple tasks and train in other areas as needed
• Ability to work with a variety of tools and equipment
• Ability to maintain all logs, paperwork, and forms accurately
• Required to understand, access, and make entries to documents on the company Electronic Document System
• Ability to accurately perform job duties with minimum supervision
• Ability to adhere to cleanroom dress code and policies
• Ability to work in a multi-cultural team environment and be a team player
• Ability to work in a cleanroom environment for extended periods of time
• Punctual and Reliable!!

Required Skill Sets

• Must be detailed oriented and be able to focus on a repetitive task for long periods of time
• Must be proficient on a computer, possessing basic navigation and program knowledge
• Must be able to absorb, assimilate and accurately recall/locate and retain large quantities of data/information
• Must be able to read, write, speak and fully understand English

Competencies

• Adaptability/Flexibility
• Ethical Conduct/Integrity
• Communication/Listening
• Detail-Oriented
• Interpersonal skills
• Personal Effectiveness
• Teamwork

Minimum Qualifications (Knowledge, Skills, and Abilities)

• Basic computer navigation and program knowledge
• Strong organization and time management skills with the demonstrated ability to meet deadlines
• Pays very close attention to detail
• Ability to work independently and within a team environment  

Preferred Qualifications

• Prior Clean Room experience preferred

Compensation

Based on experience and ability

How to Apply

Interested candidates should send their resume, title(s) of job for which they wish to be considered, and salary requirements to origenjobs@origen.com. Unfortunately, due to the volume of candidates, it is not possible to follow up with all applicants, but we invite you to visit OriGen’s Career Page often, as we are updating with new opportunities frequently.  We look forward to hearing from you.

If you are interested in working at OriGen, but do not see a current opening that fits your skillset, please use the form below and you’ll be notified if a similar role becomes available.

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