Job ID R-409698 Date posted 15/10/2021 BACK TO SEARCH RESULTS Apply

R&D Engineer II

Job Description Summary

Position Summary:  

Primary focus of this position is to support in developing, optimizing, implementing, 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.

Job Description

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. May lead or manage technicians or engineering interns.

Other Responsibilities may include, however are not limited to:

  • Assist in the support of Manufacturing, Quality, Regulatory & R&D to ensure systems are compliant 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 discipline.  Biomedical Engineering or Bioengineering degree preferred.
  • Experience: 1-3 years of industrial experience in R&D or process development, preferably in medical device or other regulated FDA/QSR and ISO environment.
  • Demonstrated hands-on technical aptitude.
  • Experience in process validation (IQ, OQ and PQ), writing protocols and reports to support verification and validation activities for product commercialization; ability to assist in executing validation.
  • Excellent oral and written communication skills.
  • Ability to work in cross functional teams.

Preferred Qualifications:

  • 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.

Education and/or Experience:

  • B.S. degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering or other related engineering discipline.   Biomedical Engineering or Bioengineering degree preferred.
  • Experience: 1-3 years of industrial experience in R&D or process development, preferably in medical device or other regulated FDA/QSR and ISO environment.

Physical Demands:

While performing the duties of this job, the employee is regularly required to stand, walk, sit, use sight, and use hands to manipulate, handle or feel objects, tools, controls, and office equipment. The employee frequently is required to verbally communicate with other associates. The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch. 

Work Environment:

While performing the duties of this job, the employee may be in an open cubicle environment.  Candidate must be able to work in a team-oriented, fast-paced environment. BD is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce. On occasion the employee may work in a preclinical setting like an animal lab, cadaver lab or attend clinical case observations.

This job description is intended as a summary of the primary responsibilities of and qualifications for this position. The job description is not intended as inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may be required either now or in the future.

Primary Work Location

IRL Wexford - Enniscorthy

Additional Locations

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