Job Description Summary

Job Description

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

1. Design development and implementation. : Designs, develops and implements existing products and processes of a medical device, translating ISO standards into tangible engineering specifications and drawings. ISO 80369-7:2021 is the primary ISO standard that will be implemented. Makes and presents engineering decisions. Participates and leads cross-functional teams in the implementation of ISO standards applicable to medical device.

2. Process Development: develops new processes by understanding key process inputs and outputs, using statistic methods such as DOE as appropriate. Develops new process equipment and tooling, including specification development, vendor selection and negotiation.

3. Documentation: write and review product development plans, design reviews, technical documents and reports. Prepares and approves verification and validation protocols and reports. Develops and implements procedures.

4. 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.

5. Testing: conduct engineering and competitor evaluations, and development unit testing. Plan, develop, execute and manage verification and validation activities for products and processes.

6. Fiscal: Creates, controls, manages a project budget (expense and/or capital expenditure). Create and critique engineering cost analysis.

Other Responsibilities may include, however are not limited to:

• Support Manufacturing, Quality, Regulatory & R&D to ensure systems are compliant with all internal and external guidelines.
• Support/lead 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: 6-9 years of industrial experience in R&D or process development, preferably in medical device or other regulated FDA/QSR and ISO environment (Masters degree plus with 4-6 years or Ph.D. degree with 3-4 years, medical device or equivalent industry experience).
• 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 execute validation.
• Ability to create and execute project plans.
• Ability to lead cross functional teams.
• Basic tooling, design and drafting knowledge.
• Excellent oral and written communication skills.
• Ability to analyze data, interpret results, and write reports. Proficient in statistic software.
• Training in Six Sigma or Design for Six Sigma.

Preferred Qualifications:

• Masters degree in relevant engineering discipline.
• Knowledge of cGMP and GLP 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: 6-9 years of industrial experience in R&D or process development, preferably in medical device or other regulated FDA/QSR and ISO environment (Masters degree plus with 4-6 years or Ph.D. degree with 3-4 years, medical device or equivalent industry experience).

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.

Required Skills

Optional Skills

.

Primary Work Location

Additional Locations

Work Shift