Senior Staff Engineer, PIVC Product Development Engineering

Job Description Summary

The R&D team is seeking a highly talented and passionate individual to help us identify and implement innovative solutions to address current and future health care needs in the Peripheral Vascular Access (PIVC) markets.

Within BD Medication Delivery Solutions (MDS) Research & Development, the associate in this position will be part of the PIVC Lifecycle Management R&D team.

This Senior Staff R&D Engineer is responsible for developing and implementing innovative product improvements, and critical component changes for high volume, disposable medical devices.

This engineer will also be accountable for developing workstream’s to educate and train our diverse engineering team.

If you would like to know a bit more about this opportunity, or are considering applying, then please read the following job information.

Responsibilities

• Drive the design and development of product systems, subsystem and components by understanding design space with design options and tradeoffs, handling critical parameters, using design for manufacture principles as well as geometric dimensioning and tolerancing tools.
• Integrate product systems and sub-systems to meet business objectives by addressing targeted customer needs and product requirements under defined cost targets.
• Identify the best tools and approaches to effectively solve engineering problems to develop and optimize designs by using an appropriate mix of first principles / analytical, computational and experimental methods.
• Ensure implementation and difficulty of product development processes and design control procedures.
• Support the evaluation and assessment of new technologies, intellectual property, products, processes and industry trends that can or have the potential to impact our business strategies.
• Support current products in terms of quality, manufacturing, supply continuity and cost improvement.
• Support the execution of technical and / or multi-functional project work.
• Contribute to a culture of innovation by proactively generating novel concepts for new products and improvements to current product performance.
• Understand customer needs through literature review, customer interviews, direct observation, competitive analysis, prototype evaluation, and clinical / simulated use studies.
• Translate customer needs into engineering requirements into specific product, packaging and process specifications.
• Analyze design solutions using engineering first principles and sophisticated engineering methods such as FEA.
• Write detailed technical reports based on design verification analysis / testing for design changes and product design activities.
• Develop and implement test methods which specify measurement equipment, test set-up, measurement systems analysis, and data analysis.
• Develop realistic and actionable design plans.

Desired Qualifications

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

A Master’s degree in engineering is preferred.

• 8+ years of engineering experience or equivalent is required with a strong preference for least 2 years product design and development experience in medical devices / products.
• Medical device design and development experience related to high-volume manufacturing is strongly preferred.
• Strong interpersonal and influencing skills.
• Advanced technical judgment.
• Strong communication skills.
• Collaborative and team oriented.
• Significant understanding of disciplined product development processes, regulatory, and quality requirements.
• Strong fit and alignment with BD values.

Experience to include :

• Demonstrated ability to deliver robust and successful products by following a disciplined design process such as Design for Six Sigma.
• Demonstrated ability to apply statistical tools, computer analysis and engineering fundamentals to support sound engineering judgment.

Experience with Solidworks, Minitab, and FEA (Abaqus / Fluent) is preferred.

• Experience in developing project and technical development plans.
• Design control experience.
• Experience writing invention disclosures, patent applications, patents, and publications.
• 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 clinical studies, human physiology, and simulated product use studies.
• Experience with contact and non-contact metrology.
• Knowledge of high-volume manufacturing and assembly processes, particularly those of plastic injection molding, metal stamping and automated assembly techniques.
• 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 21CFR820.30.

Primary Work Location

USA UT - Sandy

Additional Locations Work Shift

J-18808-Ljbffr