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Careers 2018-01-17T19:23:21+00:00

ThermoGenesis, a wholly owned subsidiary of Cesca Therapeutics, is a pioneer and market leader in the development and commercialization of automated technologies for cell-based therapeutics and bio-processing. We’re dedicated to advancing technologies and improving lives.

Open Positions

POSITION:                          Quality Engineer    

Department:                         Quality

POSTING DATE:                  January 9, 2018          

 

Job Summary

  • Support the manufacturing of Disposable Devices to achieve quality and business objectives through sustaining and continuous improvement activities.
  • Ensures compliance to 21CFR820, ISO 13485, the Medical Device Directive, other applicable regulatory and industry standards.
  • Effectively asses risk of design changes and process controls to assure high quality.
  • Analyze quality system data (field complaints, nonconforming product, etc.) to identify adverse trends and opportunities for continuous improvement.

Responsibilities and Duties

  • Regularly monitor, investigate and review nonconformance activities and generate CAPAs/SCARs based on trends/issues identified from operations, MRB and drive them to closure
  • Perform thorough root cause analysis investigations for nonconforming product, field complaints, and supplier issues; and implement effective corrections and/or preventive actions
  • Review change orders to ensure justification, impact level, and evidence of required activities are properly documented
  • Facilitate Risk Management activities throughout the product lifecycle
  • Ensure suppliers deliver quality parts, materials, and services by effectively qualifying and monitoring supplier performance.
  • Uphold company compliance programs in support of government standards including FDA Quality System Regulation 21 CFR 820, ISO 13485.

Enable high product quality by ensuring “built in reliability and Quality by design” during product design and development technical reviews and with manufacturing partners.

Qualifications and Skills

  • S. in Mechanical or Material Science Engineering
  • 7+ years’ experience in quality, engineering, or operations in a medical device or pharma environment
  • Technical writing of manufacturing procedures, work instructions, test protocols and reports
  • Experience in Root Cause Analysis and Corrective Action/Preventative Action (CAPA)
  • Product Risk Management throughout the product lifecycle
  • Standard statistical principles, theories, concepts, and techniques
  • Design Controls in accordance with 21 CFR 820
  • Project management of process/product improvements
  • Quality Management Systems (ISO 13485, 21 CFR 820)
  • Failure investigations in a manufacturing environment
  • Blue print reading and interpretation including Geometric Dimensioning and Tolerance (GD&T) is preferred
  • Experience with contract manufacturing operations
  • High performing leadership skills, prioritization, communication (verbal and writing)
  • Self-starter, motivated, able to prioritize tasks and meet deadlines
  • Excels in use of Microsoft Office suite and statistical analysis software such as Minitab
  • Process Excellence (Six Sigma) and/or ASQ certifications is preferred

POSITION:                          Product Manager    

Department:                         Commercial Operations

POSTING DATE:                  January 10, 2018        

Position Summary:

Product manager develops product portfolio by identifying potential products; conducting market research; generating product requirements; determining specifications, production timetables, pricing, and time-integrated plans for product introduction; developing marketing strategies. The Product Manager is also responsible for communicating product changes and supporting customer’s technical issues including working directly with customers on-site, introducing product, providing training/troubleshooting and coordinating with technical support and service teams to ensure customer success.

 

Responsibilities and Duties:

  • Manage all Marketing issues related to new product development, continuous improvement of existing products and product line extensions
  • Participates in cross functional activities related to product development and is responsible for completing new projects in a timely and successful manner.
  • Develops and updates all marketing related materials for all products, including customer requirements and market research information.
  • Bring new products to market by analyzing proposed product requirements and product development programs; establishing time schedules with engineering and manufacturing.
  • Coordinate all activities related to labeling, packaging, instructions for use, translations
  • Assist in developing product literature and promotional materials
  • Launch new products in world- wide markets and assist in preparation of all launch activities including training and education of internal/external partners when launching new products
  • Conduct and lead post-launch product trials with customers and generate clinical updates for publication.
  • Determine customers’ needs and desires by specifying the research needed to obtain market information.
  • Recommend the nature and scope of present and future product lines by reviewing product specifications and requirements; appraising new product ideas and/or product or packaging changes.
  • Assess market competition by comparing the company’s product to competitors’ products.
  • Develop product line communications to customers and distributors.
  • Obtain product market share by working with sales team to develop product sales strategies.
  • Assesse product market data by communicating with customers
  • Introduces and markets new products by developing time-integrated plans with marketing and sales teams.
  • Determines product pricing by utilizing market research data; reviewing production and sales costs; anticipating volume; costing special and customized orders.
  • Maintains product management training support teams, i.e., technical support/services and distribution teams.
  • Maintains professional and technical knowledge by attending conferences, and educational workshops; reviewing professional publications; establishing personal networks; participating in professional societies.
  • Contributes to team effort by accomplishing related results as needed.

Qualifications and Skills:

  • Minimum of a Bachelor’s degree in Marketing, Science or Business
  • Experience in product management, project management, new product launch and market research or analysis preferred
  • Prefer experience in Immunology and/or stem cell related technology
  • Global market experience in medical device industry is a plus
  • Ability to partner cross-functionally with internal and external teams
  • Excellent written/oral communication, people management and decision making skills
  • Must have attention to detail and a strong ability to analyze data
  • Ability to work and juggle multiple priorities and deliver results on time
  • Excellent computer skills required: PowerPoint, Excel, Word and MS Project
  • Travel 25-30%

POSITION:                          Technical Support Scientist/Manager   

Department:                         Commercial Operations

POSTING DATE:                  January 10, 2018        

 

Position Summary:

The Technical Support Scientist/Manager is responsible for providing technical product and clinical support to customers and distributors.  Provides follow up support in disseminating technical information on specific applications. Prepares training plans, presentations and conducts technical training and installations for customers. In addition, provides training materials and conducts technical product training for distributors and/or employees.

Responsibilities and Duties:

  • Fully competent in the application and operation of products.
  • Provide high-quality technical support for all products and services to international customer technical support groups and field service engineers and works with distributors to maintain ongoing contact with customers.
  • Prepare and keep current installation and training documentation, presentations and create technical documentation including field bulletins, installation and training manuals, troubleshooting guides.
  • Schedule and conduct product installations. Provide customer training enabling users to perform all tasks on the system needed to complete the installation and achieve productive use.
  • Assist customers during product performance qualification and product validation runs.
  • Works closely with distributors to clinically and technically support customers in pre- and post-sales situations.
  • Perform troubleshooting procedures to identify and resolve problems.
  • Assist distributors with product demonstrations or clinical advice.
  • Participate in the development of customer training tools and provides input about relevant clinical tools needed for future products and services.
  • Communicates/reports all relevant customer information including product and/or customer problems or sales opportunities.
  • Provide timely and complete reports of activity as required.
  • Collaborate with subject matter experts to expedite solutions and meet customer expectations.
  • Interact with R&D, Sales, Marketing, Manufacturing, Quality and other departments as needed to improve products and customer experience.
  • Actively participate on project teams for new products and changes to existing products.
  • Responsibilities include service requirements, support strategies, product testing, servicing procedures, technical documentation, spare parts, field service training and on-site support.
  • Provide global on-site support for escalated situations and business needs as required.

Qualifications and Skills:

  • Minimum Bachelor’s degree in biological sciences, i.e., biology, immunology, cell biology, etc. or bioengineering required. Minimum 3 years technical or clinical experience and customer, user or industry experience. Previous sales experience is a plus. Possesses the following knowledge:
  • Cell processing and analysis – PB, BM, leukopaks, etc.
    • Cell separation/isolation
    • Cell counts and cell recovery
    • Mass balance
    • Flow cytometry
    • Microscopy
    • Cell Therapy
  • Diagnosis of various user and equipment errors
  • Well defined organizational skills and decision-making ability. Ability to prioritize multiple assignments and multitask.
  • Five + years formal or informal training experience.
  • Strong interpersonal skills, with a high degree of self-motivation and ability to work independently.
  • Effective problem and troubleshooting skills.
  • Experience working in a cGMP/ISO regulated industry desirable.
  • Strong PC skills, including intermediate to advanced knowledge of Microsoft Office.
  • Excellent communication skills – ability to interface and influence at multiple organization levels.
  • Committed to customer satisfaction; quality focused; resourceful; able to work independently and in a team environment.
  • Domestic and international travel up to 30%

POSITION:                          Manufacturing Engineer, Medical Device

Department:                         Engineering

POSTING DATE:                  January 16, 2018        

Job Summary

Provide support for manufacturing operation, new technology introduction, manufacturing development, process validation and day to day manufacturing activities. Position requires:

  • Knowledge of the production and process development of medical devices
  • Sustain engineering activities for existing products
  • Installation of manufacturing equipment and transfer of new technologies to production
  • Knowledge of relevant validation protocols (IQ,OQ, PW) involving all aspects of process and product validation i.e., manufacturing process instructions, test protocols, manufacturing software, design of experiments, engineering studies, root cause analysis and the creation of pFMEA’s
  • Participation in cross-functional teams in which engineering activities are coordinated through project plans
  • Must be comfortable providing technical leadership for operations personnel and presentation of technical data to management

Responsibilities and Duties

Major Activities:  Apply engineering principles to the manufacture of medical devices in a cleanroom environment.  In-depth knowledge of plastics methods of assembly for small to medium scale volumes.

Essential activities: 

  • Initiate Engineering Change Requests
  • Initiate and review manufacturing process instructions (MPIs)
  • Participate in Material Review Board (MRB) to address non-conforming assembly/components
  • Conduct feasibility studies
  • Perform engineering analyses as it pertains to troubleshooting, verifications, writing and conducting test protocols.
  • Improve product manufacturability and establish manufacturing solutions
  • Sustaining and technical support for existing products
  • While working as a member of a multi-functional project team, changes to products to be developed in adherence to specified Design Control and Product Development Processes while achieving performance that satisfies Product Specifications within planned timeframes.
  • Participate in transfer-to-manufacturing activities and establishment of process validation for product assembly
  • Work with external suppliers (Contract Manufacturers, distributors, etc.) to sustain existing products
  • Effectively communicate verbally and in writing with Engineering management as well as all functional areas within the organization.
  • Travel 5-10%

Qualifications and Skills

BS in ME

5+ years related experience in medical device manufacturing

Tactical and/or strategic skills

  • SolidWorks parts, assemblies and drawings
  • Experience with medical devices and systems that incorporate mechanic, electronics and software a plus
  • Manufacturing process validation
  • Strong analytical and problem-solving skills
  • Ability to accurately estimate technical and time requirements to complete planned activities
  • Ability to define the objectives, requirements, and assumptions necessary
  • Communication, teamwork and time management skills

ThermoGenesis is an Equal Opportunity Employer.  If you are interested and meet these qualifications, please forward your resume to Human Resources at hr@thermogenesis.com.