Job Description Summary
We are a global business within BD Medical, dedicated to delivering quality and innovative solutions in Infusion Specialty Disposables. The business is committed to maintaining its accelerated growth through portfolio diversification, differentiated offerings and geographic / market expansions, while maintaining the profitability of the core product lines. We manage a healthy portfolio of programs ranging from incremental innovation to disruptive & breakthrough opportunities enabling medication delivery solutions. Our engineers and scientists have passion for bringing new technical solutions to meet serious unmet clinical needs, have strong records of professional achievement, and have the capacity and desire for continuous development and growth. We strive to provide each individual with opportunities to develop skills, gain and share knowledge, understand and deliver what our customers want and build a rewarding and fulfilling career.
We are recruiting for a highly driven technical leader with a passion for product development and a proven track record of successfully developing medical products. The successful candidate has a unique opportunity to join a high-caliber R&D team responsible for the development of products in a growing businesses within BD Medication Delivery Solutions (MDS).
Reporting to the Director of Systems Engineering, the Sr. Staff Engineer will progress design concepts through the product development stages utilizing processes and skills such as BD's Global Product Development Systems (GPDS), Project Management, Design of Experiments, Design for Six Sigma, Design for Manufacturability and Statistical Analysis for a dynamic portfolio of new product development and product engineering projects.
- Lead the R&D team over the continuum of product development; Define, plan, coordinate & communicate R&D deliverables on the program and maintain collaborative relationships with cross-functional team including Marketing, Quality, Regulatory, Manufacturing Technology and Operations. Deliverables could include:
- Translation of customer and operational requirements into verifiable product requirements and specifications for product systems, subsystems, interfaces and components and maintain traceability throughout the development process.
- Drive design decisions at the intersection of material, form factor, process, human factors considerations that enable robust system architectures that are built upon deep subject matter expertise in key foundational technology domains.
- Synthesize, develop, update and optimize designs that meet requirements by understanding design space with design options and tradeoffs, managing critical parameters, leverage strong engineering fundamentals and tools and integrating manufacturing principles early in the development.
- Critically evaluate and analyze system performance and reliability and ensure the design space is adequately pressure-tested to satisfy user, regulatory and business requirements. Understand system and subsystem design sensitivity and identify and address early any potential design integration and transfer risks.
- Implement DFSS rigor throughout the design selection and development process, leveraging and deploying empirical, statistical and analytical tools which will improve design decisions and reduce design iteration cycle times.
- Ensure the design considerations are embedding all applicable DFX (Design for Excellence) aspects including manufacturability, serviceability, reliability and safety.
- Provide technical ownership for product design aspects for developmental and commercial products within the platforms throughout their entire lifecycle. Resolve technical problems. Create solutions for technical problems using systematic problem-solving methodologies.
- Provide subject matter expertise and stay current with cutting edge technologies and material advancements to improve the rigor of Design and Development. Conduct in depth research and assessment of the industry landscape from IP, regulatory, products, technologies standpoint. Present and lead technical reviews at the various stages of Design and development. Facilitate effective multi-functional communication and engagement
- Mentor junior engineers and technicians in the execution of R&D project deliverables.
- Follow the Design Control process for medical devices and ensure compliance with all local, state, federal, international and internal safety regulations, policies, and procedures.
- Education: Minimum BS in Mechanical, Chemical, Materials or Biomedical Engineering or related field. MS/PhD preferred.
- Minimum 6 years of experience (or educational equivalent) leading / supporting product development projects in the medical device industry.
- Experience with implementing product changes through a structured, phase-gated, product development process.
- Critical Thinking:
- Skilled at finding logical flaws in arguments and plans; provides detailed insight and constructive criticism into problems and complex situations; foresees problems and potential solutions
- Ability to identify, break down and solve deep technical problems.
- Leadership Skills:
- Strong sense of accountability and action orientation.
- Ability to set direction, align goals, lead and influence others in a matrix organization
- Ability to analyze, organize and present large amounts of data in a clear and concise manner.
- Ability to appropriately set a technical vison/strategy, distill the vison into an actionable plan and delegate effectively to extended engineering team members
- Excellent interpersonal, communication, presentation and cross functional influencing skills
- Ability to mentor and coach junior members in the organization.
- Displaying Technical Expertise:
- Design for Six Sigma and proficiency with statistical techniques including familiarity with analysis of variance (ANOVA) and design of experiment (DOE) methodologies is highly desirable
- Keeps their technical skills current through literature review and attending conferences;
- Feels a strong desire & has the ability / willingness to learn and acquire new skills, knowledge and subject matter;
- Effectively applies specialized knowledge and skills to perform work tasks;
- Masters the technical skills, knowledge, and tasks associated with the role
- Making Accurate Judgements and Decisions:
- Bases decisions on a systematic review of relevant facts and information
- Uses logical and theoretical thought process to make decisions in cases of insufficient information
- Feels comfortable with ambiguity, making practical assumptions with engineering justifications, where needed.
Primary Work LocationUSA CA - Brea