Engr , Product Development

Position: Engr 2, Product Development
Description:

Pay Rate: $43/hour

Job Description Summary
Support BD's Vascular Access Device business in converting all products to ISO 80369 compliance. Activities focus on ensuring external vendor compliance to ISO 80369 in support of BD's required timeline and providing ISO compliance functional testing oversight (for internal and external Luer components).

Job Description
The preferred candidate will have strong technical design skills, excellent written and oral communication skills, and leadership abilities. This candidate should possess a strong capability to interpret and ensure compliance with all local, state, federal and BD
safety regulations, quality policies, best practices and procedures through appropriate communication, training, and education. Other duties and responsibilities include but are not limited to the following:

Technical Product Design:

• Identify the best tools and approaches to effectively solve engineering problems to develop, optimize and/or analyze designs by applying the appropriate mix of first principles, analytical, computational and experimental methods.

• Ensure the implementation and rigor of product development processes and design control procedures.

• Support current products in terms of quality, manufacturing, supply continuity and cost improvement.

• Support execution of technical and/or cross-functional project work.

• Write detailed technical reports based on design verification analysis/testing for design changes and product design activities.

• Develop and execute test methods which specify measurement equipment, test set-up, measurement systems analysis, and data analysis.

• Develop realistic and actionable design plans.

Organizational Development:

• Proactively develop, maintain & share technical knowledge in specialized area(s), remaining up-to-date on current trends and best practices.

• Develop and apply innovative approaches to ensure the effective capture, retention and communication of technical and project knowledge generated (tacit & implicit).

• Effectively collaborate with laboratory technicians and support staff.

• Ensure compliance with BD quality policies, procedures and practices as well as with all local, state, federal and BD safety regulations, policies and procedures.

Desired

Qualifications:

• BS degree in Engineering (Mechanical Engineering, Materials Science & Engineering, Biomedical Engineering or a closely related engineering degree required)

• Minimum of 2 years of engineering experience or equivalent is required with a strong preference for least 1 year product development and design experience in medical devices / products

• Strong interpersonal and influencing skills.

• Excellent technical judgment.

• Strong communication skills.

• Demonstrated accountability for successful completion of designated tasks.

• Team oriented.

• Understanding of disciplined product development processes and quality requirements.

• Strong fit with BD values.

Experience to include:

• Demonstrated ability to utilize statistical tools, computer analysis and engineering fundamentals to support sound engineering judgment. Solidworks, Minitab, and FEA (Abaqus / Fluent) experience is preferred.

• Experience in developing project / technical development plans.

• Design control experience.

• Developed understanding of DOE and statistical methods.

• Understanding of failure theory and modes for plastics, elastomers, and metals due to static and time-variable loading conditions.

• Experience with contact and non-contact metrology.

• Knowledge of high-volume manufacturing and assembly processes, particularly those of plastic injection molding.

• Experience with manufacturing process validation including strategy development, First Article Inspection, Factory
Acceptance Testing, and IQ/OQ/PQ's.

• Knowledge of disciplined product development processes, regulatory and quality requirements such as 21

CFR
820.30