The preferred candidate will have strong technical design skills, excellent written and oral skills, and developed 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:
- Drive design and development of product systems, subsystem and components by understanding design space with design options and tradeoffs, managing critical parameters, using design for manufacture principles as well as geometric dimensioning and tolerancing tools.
- Integrate product systems and subsystems to meet business objectives by addressing customer needs and product requirements under defined cost targets.
- Identify the best tools and approaches to effectively solve engineering problems to develop/optimize designs by leveraging appropriate mix of first principles / analytical, computational and experimental methods.
- Ensure implementation and rigor of product development processes and design control procedures.
- Support 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.
- Lead execution of technical and/or cross-functional project work.
- Contribute to a culture of innovation by proactively generating novel concepts for new products and enhancements 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 advanced engineering methods such as FEA
- 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.
Project and Cross-Functional Leadership:
- Demonstrate strong accountability for successful completion of designated tasks
- Develop project schedules and demonstrate strong accountability for successful completion of projects/programs and team deliverables
- Ensure efficient and effective transition from research to development to high volume manufacturing in locations throughout the world
- Provide project leadership to cross-functional teams comprising QA, Medical Affairs, Regulatory Affairs, Marketing, and Manufacturing team members
- Effectively lead and direct the work of other engineers and laboratory technicians
- Ensure compliance with BD quality policies, procedures and practices as well as with all local, state, federal and BD safety regulations, policies and procedures
- Proactively develop, maintain & share technical knowledge in specialized area(s), remaining up-to-date on current trends and best practices.
- Actively lead, mentor and motivate team members and junior associates, while also ensuring effective cross-functional communication and engagement
- Develop and apply innovative approaches to ensure the effective capture, retention and communication of technical and project knowledge generated (tacit & implicit).
- 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 strongly preferred.
- Minimum of 8 years of engineering experience or equivalent is required with a strong preference for least 3 years product development and design experience in medical devices / products
- Education requirement may substitute for years of work experience as follows:
- Masters and 6 years of relevant work experience
- Medical device design and development experience related to high-volume manufacturing is strongly preferred.
- Strong interpersonal and influencing skills.
- Advanced technical and business judgment.
- Strong communication skills.
- Team oriented.
- Strong understanding of disciplined product development processes, regulatory, and quality requirements.
- Strong fit with BD values
Experience to include:
- Demonstrated ability to deliver robust products by following a disciplined design process such as Design for Six Sigma
- 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.
- Project leadership and management experience
- Experience in developing business cases and project plans
- Strong design control experience
- Experience writing invention disclosures, patent applications, patents, and publications
- Strong understanding of DOE and statistical methods.
- Strong 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, including solvent bonding, adhesive bonding, ultrasonic welding, and interference-fitting.
- 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