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.

Current Job Openings:

Buyer / Planner

Position Summary

The Buyer/Planner will perform and manage plant supply chain activities. Ensure the continuous supply of high quality, low cost raw materials efficiently to keep daily operations running, while maintaining and reporting metrics that allow us to evaluate the performance of our suppliers. Confirm materials and capacity, plan and schedule production work orders to meet master schedule requirements. Manage inventory levels of raw material and work in process and manage inbound and outbound logistics.

Essential Duties and Responsibilities

  • Review and analyze weekly requirements generated by Epicor to determine what materials should be purchased.
  • Generate and track purchase orders for raw materials in order to ensure on time delivery.
  • Review and determine the availability of materials and capacity to meet the schedule in order to ensure that the production of final products meets customer needs.
  • Verify the availability of materials, weekly, relative to the production plan and make necessary adjustments to the weekly build schedule.
  • Manage inbound and outbound logistics to optimize the lead time, transportation costs, customs and regulatory clearances.
  • Evaluate Supplier Quality (in conjunction with Quality Assurance Engineer) and Delivery Performance and provide feedback to the supply base.
  • Work with the supply base to ensure timely delivery of supplier documentation (invoices, CoCs, etc.) to ensure a smooth flow of goods through the logistics pipeline as well as Incoming Quality Assurance.
  • Manage the return of rejected products with the supply base and follow up to receive the credit for the returned product.
  • Review and approve change orders in order to determine the impact of changes on material in the warehouse, on order and work in process. Work to minimize obsolescence.
  • Maintain MRP data in Epicor to ensure that the Epicor requirements correctly generate new raw material purchases.
  • Drive improvements in quality, cost and delivery of supplied components.
  • Coordinate the inspection of first articles when needed.
  • Resolve inventory discrepancies as appropriate.
  • Comply with all requirements, duties and obligations of our Quality Management System.
  • Comply with healthy and safety initiatives, policies and procedures. Identify opportunities to improve health and safety.
  • Safeguard all documents, confidential information, equipment, tools, raw materials, products or other assets directly related to their area of ​​work.

Required Skill Sets

  • Must be proficient on computer, possessing intermediate/ advanced 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)

  • 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

  • B.S. or Masters degree in Engineering or Business Administration. At least 7 years of supply chain experience. At least 5 years experience in purchasing and production planning.
  • APICS CPIM certification. Experience in logistics and warehouse operations. Medical device experience preferred.
  • Knowledge and use of Epicor.

Supervisory Responsibility

This position has no supervisory responsibilities.

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 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. 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. The noise level in the work environment is usually moderate.

Salary:

Commensurate with Experience.

Material Handler

Position Summary

The Material Handler provides material handling and storage support for the manufacturing activities at OriGen. Coordinates shipments to and from sterilization for finished products and from internal location to location. Interfaces with warehouse team at main location on a daily/ weekly operational level to ensure basic service levels and procedures are followed.

Essential Duties and Responsibilities

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

  • Ensure inventory and shipment accuracy.  Compile and maintains reports.  Maintain inventory accuracy by periodic cycle counting.
  • Analyze and correct discrepancies. Deallocate/reallocate as necessary.
  • Create and monitor work orders for sterilization.
  • On-going organization and maintenance of the materials storage area.
  • Collect, categorize and compartmentalize production materials and components.
  • Kit and stage manufacturing builds.
  • Track and receive material from vendors, support and track internal QA inspection for Manufacturing production facility.
  • Track and document movement of materials in and out of storage area using ERP system.
  • Assist in accommodating temporary storage needs.
  • Assist with the procurement, delivery and pick-up of manufacturing components from local vendors.
  • Assist with all shipping and receiving related to the manufacturing activities.
  • Ensure that all responsibilities within the scope of this job comply with the scope of the OriGen Quality System.
  • Handle manufacturing related documentation including ECO’s, bill of materials, routers, rework instructions, NCR’s, CAPA’s.
  • Ensure clean room supplies inventory is maintained at an adequate level.
  • Ensure test lab and production support area supplies inventory is maintained at an adequate level.
  • Perform tool tech duties as required for manufacturing location.
  • Any other duties required within the job role.
  • Other duties and/or projects as assigned

Required Skill Sets

  • Must be detailed oriented
  • Must be proficient on 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)

  • ERP System (Epicor preferred) experience
  • Microsoft Excel experience
  • Strong organization and time management skills with the demonstrated ability to meet deadlines
  • Able to review and analyze discrepancies
  • Ability to work independently and within a team environment
  • High school diploma or GED
  • Proficient knowledge of warehouse procedure and policy
  • Excellent problem-solving skills, communication and leadership qualities
  • Ability to work with all levels of company staff
  • Comfortable delivering frequent direct written and oral feedback

Preferred Qualifications

  • Prior warehouse experience preferred
  • Forklift Certification and Valid Driver License preferred
  • Minimum 2 years’ of related experience experience
  • Knowledge of warehousing Key Performance Indicators (KPIs)
  • Knowledge of Lean concepts

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. 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 of time. Must be able to wear personal protective equipment when required.

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 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 operated automated warehouse equipment; e.g. electric pallet jack, forklift. Specific vision abilities required by this position include close vision, distance vision, color vision, and the ability to adjust focus.

Salary:

Commensurate with Experience.

QA Technician, Inspector

The QA Technician, Inspector works with limited supervision to conduct incoming, in-process, and final product inspection; support the control and disposition of nonconforming materials and supplier corrective actions; calibrate equipment; create, finalize and maintain quality records; process customer returns; and print product labels.

Essential Duties and Responsibilities

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

  • Performs inspections of incoming, in-process, and final product for conformance to quality assurance standards using an approved sampling plan.
  • Accurately completes all quality control documentation and inspection sheets in accordance with ISO 13485 Standard and established procedures.
  • Verify inspection equipment, machinery and tools used are calibrated per company policy.
  • Follows verbal and/or written instructions such as production traveler, work instruction, process specifications, and drawings at the direction of supervisor in completing a variety of inspection tasks.
  • Makes decisions as to the acceptable quality; determines reasons for rejection; completes required quality records.
  • Identify, initiate quarantine, report and document all nonconforming product.
  • Bring problems/issues to attention of Management.
  • Work efficiently to achieve targeted goals as set by the production schedule.
  • Participates and/or assists with cross training activities, training of new hires and temporary staff.
  • Follows set training program for position and ensures training requirements are up to date.
  • Demonstrates safe work habits, maintain clean and safe work area.
  • Performs other duties as assigned, to maintain efficiency throughout the company.
  • Conducts equipment calibration activities, requiring a good understanding of current metrology practices and use of measuring instruments.

Competencies

  • Self-starter
  • Close attention to detail
  • Ability to perform product inspections, including understanding of drawing dimensions and tolerances.
  • Understanding of the selection and use of sampling plans.
  • Familiar with quality tools and procedures
  • Creativity and curiosity
  • Organizational and time management skills
  • Good math, technical writing and computer skills.
  • Effective problem-solving skills
  • Ethical Conduct
  • Communication and interpersonal skills
  • Adaptability, can work with changing priorities
  • Measured decision making
  • TeamworkWork Environment

Minimum Qualifications (Knowledge, Skills, and Abilities)

  • High school diploma
  • 1 – 3+ years’ experience working within a formalized FDA or ISO Quality System.
  • 1 – 3+ years’ experience within a medical device manufacturing environment.

Preferred Qualifications

  • Associate degree or professional certification

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.

  • 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 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.

Strategic Partnerships Associate

Position Summary

The Strategic Partnerships Associate maintains and grows relationships with the global distributors of OriGen Biomedical products. This position grows the distribution network by working with distributors in new or existing geographies and manages all relevant contracts, agreements and non-disclosure agreements in place with the distributors and key accounts.

Essential Functions

Daily activities include:

  • Assists in the onboarding, training, ongoing management and off-boarding of global distributors
  • Develop and maintain third-party contracts/agreements/non-disclosure agreements with key accounts, as needed
  • Monitor contract obligations from both parties and initiate action accordingly.
  • Evaluate distributor sales records to identify sales trends, obtain sales forecasts from distributors, and support distributors to meet sales objectives
  • Participate in business review meetings and present reports on sales results, analysis, opportunities and forecasts
  • Ensure fast customer support to enable future opportunities with distributors and other key accounts
  • Works with OriGen regulatory department to ensure compliance with foreign trade regulations, international product registration processes, and additional relevant legislative concerns with regards to medical device sales internationally
  • The role encompasses management of teams (direct & indirect management) establishing and maintaining many essential processes, ensuring distributors are equipped to comply with relevant regulatory requirements regarding distribution and sale of OriGen products, allowing products to be maintained in the market place and ensuring minimal impact on Supply Chain performance measures and customer satisfaction
  • Working with Quality & Regulatory, identifies global supply chain processes within the organization that are impacted by the EU MDR legislation and recommends solutions required to achieve MDR compliance including any system enhancements required within overall supply chain
  • Attend trade shows, labs and conferences, as necessary
  • This requires supporting and influencing cross-functional team members in Regulatory, Quality, Engineering, Marketing, Finance, and External Distributors.

Competencies

  • Experience with managing global distributors and geographically dispersed teams
  • Experience in analyzing pricing, sales, forecasts, and contracts
  • Team oriented and possessing strong collaboration skills to liaise with sales, product management, customer service, engineering, regulatory, and senior management
  • Self-starter managing day to day tasks and working in collaboration to accomplish deadlines and objectives
  • Accountable for all work and projects and self-directed to provide status updates to relevant parties
  • Exercises judgment within broadly defined practices and policies
  • Experience with an online CRM/SalesForce.com preferred
  • Proficiency with Google G Suite (Gmail, Sheets, Docs, Hangouts, etc.) and Microsoft Office including Word, PowerPoint and Excel
  • Outstanding communication skills, both written and oral
  • Experience in the medical device and/or pharmaceutical industry

Supervisory Responsibility 

This position has no supervisory responsibilities; however, the individual may be required to lead projects and ensure participants meet deadlines.

Position Type and Expected Hours of Work

This is a full-time position.

Days and hours of work are typically Monday through Friday, 8:30 a.m. to 5 p.m. In some cases, additional work hours may be required.

Travel

5%

Required Education and Experience

  • Bachelor’s Degree or equivalent in business, international business, or related field
  • Minimum of 1 years’ experience in medical device business management discipline: knowledge of domestic and international medical device regulation, practical experience in global registrations and filings (i.e. US, EU, Canada.)

Preferred Education and Experience

  • Minimum of 3 years in supply chain management

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.

Physical Demands 

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 5:45am – 2:15pm).

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

The Clean Room Tech (CRT) is responsible for: assembly, testing and packaging of medical devices and components. Required to understand and comply with drawings, written procedures, batch records and 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 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