Sales Support Specialist

Company: BD (Becton, Dickinson and Company)
Location: Ashland
Posted on: June 8, 2021

Job Description:

Job Description Summary

Job Description

Primary focus of this position is to assist in developing, optimizing, and validating components/elements of a medical device. The candidate will perform hands-on testing in optimization of a device; conduct process development activities to understand process inputs and outputs; assist/write technical documents, validation protocols and reports; prepare work instructions and standard operating procedures; assist in conducting design and process qualification and validation; support equipment development; support other activities from R&D, Quality, Operations, and Regulatory Affairs.

Primary focus of this position is to assist in developing, optimizing, and validating components/elements of a medical device. The candidate will perform hands-on testing in optimization of a device; conduct process development activities to understand process inputs and outputs; assist/write technical documents, validation protocols and reports; prepare work instructions and standard operating procedures; assist in conducting design and process qualification and validation; support equipment development; support other activities from R&D, Quality, Operations, and Regulatory Affairs.

Essential / Key Job Responsibilities (including supervisory and/or fiscal):

Design: Design components of a medical device, translating intangible design inputs into tangible engineering specifications and drawings. Select appropriate materials, processes and vendors to achieve the design, and challenge these designs against design specifications, clinical use scenarios and international standards. Build test parts for engineering evaluation, pre-clinical studies and clinical studies. Process Development: assists in the development and optimization of processes to understand key process inputs and outputs, using statistic methods such as DOE as appropriate. Supports new process equipment and tooling development, including specification development, vendor selection and negotiation. Documentation: prepare work instructions and standard operating procedures (SOP), write technical documents and reports. Prepare raw material specifications and drawings. Assist in preparing verification and validation protocols and reports. Test Method Development: develop new engineering test methods and clinically relevant simulated use test methods in conjunction with R&D technicians; prepare and assist in the validation of test methods. Testing: perform lab bench testing, conduct engineering and competitor evaluations, development unit testing, and execute verification and validation activities. Training: train technicians on new design and process development as well as new test methods. Assist/conduct new process development training with operations and quality assurance. Supervisory/mentoring/coaching: Mentor/coach R&D technicians through New Product Development activities like new process development, R&D materials/inventory control etc.

Other Responsibilities may include, however are not limited to:

• Assist in the support of Manufacturing, Quality, Regulatory & R&D to ensure systems are aligned with all internal and external guidelines.
• Assist in design and process root cause analysis and support non-conforming product and complaint investigations.

Required Qualifications:

• B.S. degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering or other related engineering field. Biomedical Engineering or Bioengineering degree preferred.
• Experience: 0-2 years of experience in R&D or process development, preferably in medical device or other regulated FDA/QSR and ISO environment.
• Demonstrated hands-on technical capability.
• Experience in process validation (IQ, OQ and PQ), writing protocols and reports to support verification and validation activities for product commercialization.
• Excellent oral and written communication skills.
• Ability to work in multi-functional teams.

Preferred Qualifications:

• Ability to assist in executing validation is a plus.
• Ability to analyze data, interpret results, and write reports. Proficient in statistic software is a plus.
• Knowledge of cGMP and GLP is a plus.
• Training in Six Sigma or Design for Six Sigma is a plus.

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

Primary Work Location

USA UT - Salt Lake City BPV Satellite

Additional Locations

Work Shift

Keywords: BD (Becton, Dickinson and Company), Medford , Sales Support Specialist, Other , Ashland, Oregon