Founded in 1997 and headquartered in Austin, Texas, OriGen Biomedical® is a privately-held medical device manufacturer that is experiencing growth. Our company is a leading producer of cryopreservation and cell culture products with a focus on developing a range of solutions to support the treatment of life-threatening diseases such as cancer and genetic conditions. Our products are designed with both the patient and user in mind, and we take pride in our commitment to providing excellent customer service to ensure patient care always remains our top priority. The primary way to achieve this is by attracting and hiring the right people who share our vision.
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Current Job Openings
How to Apply: Interested candidates should send their resume, title(s) of job for which they wish to be considered, and salary requirements to hr@origenbio.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.
Senior Quality Engineer
Position Summary
The Senior Quality Engineer is responsible for technical duties within the Quality organization including validation and qualification, calibration, and customer contact. These duties will support manufacturing operations, customer service, process improvement, and Regulatory requirements.
Essential Duties and Responsibilities
The essential duties and responsibilities of this position include, but are not limited to the following:
- Assesses new problems with identifiable factors with accuracy and good judgement
- Reviews and revises existing risk plans, plans on-going risk activities, approves low risk ad hoc risk assessments
- Plans corrective and preventative actions, advises on investigations, represents engineering at QMS meetings, assesses trending for opportunities for improvement
- Run technical programs within the Engineering and Quality departments, including calibration, sterilizer qualifications and clean room qualifications
- Completes and reviews complaint investigations and letters, may coordinate responses and follow up directly with customers
- Participates in Post Market Surveillance activities, including literature reviews, data analysis, risk updates, and report writing
- Determines methods on new assignments independently, sets individual priorities within company or department priorities
- Review design validation and verification reports and protocols
- Technical writing to include document development and review
- Assist with Technical writing to support regulatory submissions.
- Develop Root Cause Analysis on problems originating from many sources, from production to end-user.
- Support the Regulatory group with verification and validation activities, maintenance of technical files.
- Other duties and/or projects as assigned.
Required Skillsets
- Must be detail-oriented
- 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
- Self-starter
- Good math, technical writing and computer skills
- Close attention to detail
- DOE and validation testing
- Familiar with quality tools and procedures
- Broad creativity and curiosity
- Organizational and time management skills
- Seasoned problem-solving skills
- Ethical Conduct
- Communication and interpersonal skills
- Can work with changing priorities
- Adaptability
- Results-driven
Minimum Qualifications (Knowledge, Skills, and Abilities)
- Bachelor’s degree in Engineering, or equivalent
- Haas previously worked or interned experience in medical device quality / ISO 13485 environment
- Demonstrated ability to use effective and results-oriented problem solving and critical thinking skills; hands-on troubleshooting ability
- Ability to understand and interpret customer needs; ability to work with all work functions (i.e. Regulatory, Operations, Human Resources, Engineering)
- Ability to work independently and lead or participate in a team environment
Preferred Qualifications
- 3+ years’ experience in medical device quality / ISO 13485 environment
Supervisory Responsibility
This position has no supervisory responsibilities; however, the individual may be required to lead projects and ensure participants meet deadlines.
Work Environment
This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.
This job often operates in a cleanroom environment. Cleanroom environment requires personnel to wear personal clothing completely covering the legs; company-provided cleanroom coat, bouffant, face mask, and gloves.
Physical Demands and 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 office environment is usually minimal.
Salary:
Commensurate with Experience.
Cleanroom Tech for Medical Device Production - Morning and Evening Shift
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 hr@origenbio.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.
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Why Work at OriGen Biomedical
Are you looking for a job that excites and inspires you while making a difference in people’s lives?
Working at OriGen means you are directly making an impact on patient lives. Our products are used in the treatment of various conditions and life-threatening diseases. You’ll enjoy a positive, stimulating, and inclusive environment – with opportunities to grow, all while making a difference.
Our Full-Time Benefits
The physical, mental, and financial health of our employees and their families is a top priority for OriGen. This is why we have a strong, competitive benefits program, which includes:
- Competitive pay with possibilities of bonuses and merit-based raises
- Health, vision, and dental insurance plans available
- Base level health insurance is free to the employee with a $500 contribution to your Health Savings Account by OriGen
- Employer-paid long-term disability and life insurance up to 1 year of employee’s annual salary
- 401(k) Retirement Savings Plan with up to 4% matching contribution
- Flexible work schedule for most office staff
- Generous paid time off, including ten company holidays, paternity/maternity leave, and bereavement leave
- Employee Stock Ownership Program (ESOP)
- Home office improvement incentives for remote workers
- Awards and recognition
- Educational Assistance Program for undergraduate, graduate, and post-graduate studies
- Professional development and training opportunities
- Two different schedules for production employees
- 1st shift: M-F 5:45am – 2:15pm
- 2nd shift: M-Th 2:15pm – 12:45am (includes differential pay)
Our Vision
To be the supplier of choice for single-use disposables within cell and gene therapy and to support transformational therapies across the world.
Our Credo
While our primary responsibility is to the patients who ultimately receive our product, our second responsibility is to our staff, the men and women who work for OriGen. We believe each employee should have a sense of security in their job, fair and adequate wages, as well as clean and orderly working conditions. Management must be qualified and just, and the working environment pleasant.
Core Values
- Be an example of Corporate Responsibility
- Demonstrate excellence in all aspects of the company
- Foster incremental innovation
- Provide unparalleled customer service
- Advancement opportunity based on merit
- Our work should benefit the community and the world
What Makes Working at OriGen Unique
We not only improve the lives of our customers and their patients, but we also try to improve the lives of our own employees by fostering good company culture. OriGen offers a friendly workplace, where individuals treat each other with respect and kindness. Meaningful interactions between colleagues are encouraged. We are always looking to nurture talent and provide opportunities to progress, which is why we often fill available roles from within.
OriGen frequently offers fun in-office activities, led by the Diversity and Inclusion Committee, whose sole mission is to provide fun ways for employees to engage with one another.
We are a woman-led business and strive to provide an inclusive workplace for all employees no matter their age, race, gender, ethnicity, religion, sexual orientation, differing abilities, or veteran status.
Safety and Pandemic Protocols
OriGen Biomedical manufactures essential, life-saving products. As such, OriGen is an essential business and some jobs may be required to work onsite. Your health and safety is important, and while we take pride in our everyday practices to maintain a clean and sanitary environment within our facilities, at present, we have implemented additional measures that reflect the recommended standards of the Centers for Disease Control and Prevention (CDC) in response to the coronavirus.
If needed or desired, masks are available to all employees. Continuous sanitization and cleaning measures are done throughout the day. Workstations and desks are arranged in a manner to maintain a distance of 6 feet.
OriGen has maintained operations throughout the entirety of the pandemic to date, adjusting and adapting as necessary.
