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Form of work The Associate Director is responsible for Design Development for new product development and sustaining engineering for the Infusion Specialty Disposables (ISD) business groups within the Medication Delivery Solutions business unit.
This position will report solid line to the Director of Design Development for the ISD business group.
This leader is responsible for all global design and development activities (both new product development and sustaining engineering) for both the MDS (ISD and HDS) and MMS disposables devices, of which ISD (MDS and MMS) are significantly driving growth for MDS and BDX over the next several years. The WW Director will lead teams responsible for System Design, Mechanical Design, and Design Evaluation for highly complex mechanical and material product development programs including how the disposables interface with the infusion pumping systems within the MMS Business. These teams are responsible for designing, implementing, and building product as well as ensuring products meet both product and customer requirements. The Design and Development organization will collaborate with the Systems Engineering team and the V&V teams to ensure that the development of products meet product requirements and customer needs. As a highly cross-functional role, the WW Director and the teams will also collaborate with multiple organizations across geographies within Client including the Materials COE, the Biomaterials Testing COE, the Computer Aided Engineering (CAE) COE, and the Analytical Chemistry COE as well as with Marketing, Quality, Regulatory, Manufacturing Technology Innovation, and Operations.
The organizational span will be approximately 6 direct reports with a total organization of approximately 15 associates and contractors. This includes integrating with our associates in Bangalore, India. Combined, MDS and MMS Infusion Disposables represents greater than $1.3B in combined revenue that this Associate Director and team will be responsible for engineering design and development of new products and sustaining engineering of existing products.
This leader will have a proven record of product development excellence and leadership, preferably in the medical device industry. In order to effectively lead strong technical teams, s/he should be well-versed in the execution of all aspects of product development including requirements management, design, development, verification and validation, transfer to manufacturing, and other aspects relevant to successful product commercialization. The candidate must have a deep understanding of systems design, mechanical design as well as materials science. They must also have solid R&D experience employing modern, lean product development methodologies across large multi-disciplinary teams.
This Associate Director will lead the multifunctional R&D team dedicated to the development of ISD product solutions. They will have responsibility for developing a robust design, understanding user and system requirements and drive deep design and development excellence to realize the implementation and delivery of the design partnering with verification and validation team members.
This leader will possess exceptional organizational leadership, inspires, motivates and builds confidence and engagement in their team and creates an environment where associates are highly committed and perform at their best. They are also able to instill a sense of stability and a steady hand, even in unstable or challenging times.
They have the capability to partner with business and cross-functional leaders to ensure the development of the product design solution is delivered on-time, with quality.
Job Description
RESPONSIBILITIES
The Associate Director is accountable to deliver, with high technical competence and capability, product designs, analyses, reviews, prototypes, engineering studies, and products suitable for design verification and validation for high visibility, high growth programs. Responsibility spans from product definition and design through full scale product development within high growth spaces. The Associate Director is expected to leverage both skill sets within MDS as well as develop and acquire talent with new skill sets as needed to deliver on these responsibilities. S/he is also responsible for on-time and on-budget delivery for high visibility R&D milestones associated with design and development.
The Associate Director is responsible for engineering design and development for all products across two highly complex businesses and 2 platforms (MMS, MDS (ISD)) and many product offerings (Connectors, gravity sets, extension sets, pump sets). The R&D teams will provide capabilities in critical areas such as System Design, Mechanical Design and Design Evaluation. The System Design capability is responsible for translating product requirements (design inputs) from the System Engineering team into robust high-level system architecture designs that provide the roadmap for detailed design through deep Mechanical Design optimization. The Mechanical Design capability is responsible for developing the detailed designs for all aspects of product development and any updates to existing products. Engineers in this team are responsible for applying a wide variety of design and development technical approaches including design for six sigma (DFSS), computer aided design, simulation, modeling (Finite Element Analysis, Fluid Modeling), tolerance analyses, and statistical analysis as required to meet product and manufacturing requirements. The Mechanical Design capability will also be responsible for building conceptual, functional, and design verification units for evaluation and testing. The Design Development team will work collaboratively with the System Engineering and V&V teams to conduct evaluations and engineering studies of functional units throughout the development cycle to ensure designs meet system and sub-system requirements as well as customer requirements and that final design verification and validation units are suitable for formal DV testing. The Associate Director is also responsible for all design documentation associated with products within the WW ISD business.
R&D sites are located in San Diego, Brea, CA, Franklin Lakes, NJ and Bangalore, India. Manufacturing sites for which R&D is responsible for transition of product designs include Tijuana, Almaraz Spain, Sandy, Utah, Villamarzana, Italy and Cazin, Boznia. Program complexity and engineering discipline expertise ranges from intricate and tolerance-sensitive mechanical and materials designs and modeling of complex silicones, tubing and connection capability with robust processes and high-volume assembly operations. These devices are critical to support Client's solution to provide best in class medication preparation and administration globally.
As a highly cross-functional role, the Associate Director and the teams will also collaborate with multiple organizations across geographies within Client including the Materials COE, the Biomaterials Testing COE, the Computer Aided Engineering (CAE) COE, and the Analytical Chemistry COE as well as with Marketing, Quality, Regulatory, Manufacturing Technology Innovation, and Operations.
The Associate Director is the functional leader of a multifunctional R&D team which includes systems engineering, design development and verification and validation engineering personnel and has ownership for the delivery of a robust technical design implementation. The responsibilities will include leading teams across multiple sites in the US and Asia.
They will also be responsible for supporting identification and partnership with the concept leader to develop and execute R&D innovation programs and strategies in support of the business to develop concepts and establish technical feasibilities of new innovative differentiated solutions for the business. This includes searching for and synthesizing new product opportunities (internally and externally) as well as identifying and guiding the solution of technical problems. This position partners with R&D, technology development, strategic innovation and the business teams to develop realizable concepts for new opportunities.
POSITION REQUIREMENTS
KNOWLEDGE AND EXPERIENCE:
OVERALL
The successful candidate will have a proven record of product development excellence and leadership in the medical device industry with a minimum of eight years of experience. In order to effectively lead strong technical teams, s/he should be well-versed in the execution of all aspects of product development including requirements management, design, development, verification and validation, transfer to manufacturing, and other aspects relevant to successful product commercialization. The candidate must have a deep understanding of systems design, mechanical design as well as materials science. S/he must also have solid R&D experience employing modern, lean product development methodologies across multi-disciplinary teams.
The candidate must be a self-starter, have a strong work ethic, and have a experience in effective change management. Experience as a creative problem solver, a passion for continuous improvement, and the ability to work independently and within a team setting are all required attributes.
The candidate will have a reputation and record of effective collaboration with peers, subordinates and superiors as well as outside advisors and customers. S/he should also have demonstrated clear history of attracting, developing, and empowering technical talent, with an emphasis on building engineering competencies, technical excellence and engineering robustness. The candidate will have earned an undergraduate degree in engineering or similar technical discipline. An advanced degree in engineering will be advantageous.
Education
This position will report solid line to the Director of Design Development for the ISD business group.
This leader is responsible for all global design and development activities (both new product development and sustaining engineering) for both the MDS (ISD and HDS) and MMS disposables devices, of which ISD (MDS and MMS) are significantly driving growth for MDS and BDX over the next several years. The WW Director will lead teams responsible for System Design, Mechanical Design, and Design Evaluation for highly complex mechanical and material product development programs including how the disposables interface with the infusion pumping systems within the MMS Business. These teams are responsible for designing, implementing, and building product as well as ensuring products meet both product and customer requirements. The Design and Development organization will collaborate with the Systems Engineering team and the V&V teams to ensure that the development of products meet product requirements and customer needs. As a highly cross-functional role, the WW Director and the teams will also collaborate with multiple organizations across geographies within Client including the Materials COE, the Biomaterials Testing COE, the Computer Aided Engineering (CAE) COE, and the Analytical Chemistry COE as well as with Marketing, Quality, Regulatory, Manufacturing Technology Innovation, and Operations.
The organizational span will be approximately 6 direct reports with a total organization of approximately 15 associates and contractors. This includes integrating with our associates in Bangalore, India. Combined, MDS and MMS Infusion Disposables represents greater than $1.3B in combined revenue that this Associate Director and team will be responsible for engineering design and development of new products and sustaining engineering of existing products.
This leader will have a proven record of product development excellence and leadership, preferably in the medical device industry. In order to effectively lead strong technical teams, s/he should be well-versed in the execution of all aspects of product development including requirements management, design, development, verification and validation, transfer to manufacturing, and other aspects relevant to successful product commercialization. The candidate must have a deep understanding of systems design, mechanical design as well as materials science. They must also have solid R&D experience employing modern, lean product development methodologies across large multi-disciplinary teams.
This Associate Director will lead the multifunctional R&D team dedicated to the development of ISD product solutions. They will have responsibility for developing a robust design, understanding user and system requirements and drive deep design and development excellence to realize the implementation and delivery of the design partnering with verification and validation team members.
This leader will possess exceptional organizational leadership, inspires, motivates and builds confidence and engagement in their team and creates an environment where associates are highly committed and perform at their best. They are also able to instill a sense of stability and a steady hand, even in unstable or challenging times.
They have the capability to partner with business and cross-functional leaders to ensure the development of the product design solution is delivered on-time, with quality.
Job Description
RESPONSIBILITIES
The Associate Director is accountable to deliver, with high technical competence and capability, product designs, analyses, reviews, prototypes, engineering studies, and products suitable for design verification and validation for high visibility, high growth programs. Responsibility spans from product definition and design through full scale product development within high growth spaces. The Associate Director is expected to leverage both skill sets within MDS as well as develop and acquire talent with new skill sets as needed to deliver on these responsibilities. S/he is also responsible for on-time and on-budget delivery for high visibility R&D milestones associated with design and development.
The Associate Director is responsible for engineering design and development for all products across two highly complex businesses and 2 platforms (MMS, MDS (ISD)) and many product offerings (Connectors, gravity sets, extension sets, pump sets). The R&D teams will provide capabilities in critical areas such as System Design, Mechanical Design and Design Evaluation. The System Design capability is responsible for translating product requirements (design inputs) from the System Engineering team into robust high-level system architecture designs that provide the roadmap for detailed design through deep Mechanical Design optimization. The Mechanical Design capability is responsible for developing the detailed designs for all aspects of product development and any updates to existing products. Engineers in this team are responsible for applying a wide variety of design and development technical approaches including design for six sigma (DFSS), computer aided design, simulation, modeling (Finite Element Analysis, Fluid Modeling), tolerance analyses, and statistical analysis as required to meet product and manufacturing requirements. The Mechanical Design capability will also be responsible for building conceptual, functional, and design verification units for evaluation and testing. The Design Development team will work collaboratively with the System Engineering and V&V teams to conduct evaluations and engineering studies of functional units throughout the development cycle to ensure designs meet system and sub-system requirements as well as customer requirements and that final design verification and validation units are suitable for formal DV testing. The Associate Director is also responsible for all design documentation associated with products within the WW ISD business.
R&D sites are located in San Diego, Brea, CA, Franklin Lakes, NJ and Bangalore, India. Manufacturing sites for which R&D is responsible for transition of product designs include Tijuana, Almaraz Spain, Sandy, Utah, Villamarzana, Italy and Cazin, Boznia. Program complexity and engineering discipline expertise ranges from intricate and tolerance-sensitive mechanical and materials designs and modeling of complex silicones, tubing and connection capability with robust processes and high-volume assembly operations. These devices are critical to support Client's solution to provide best in class medication preparation and administration globally.
As a highly cross-functional role, the Associate Director and the teams will also collaborate with multiple organizations across geographies within Client including the Materials COE, the Biomaterials Testing COE, the Computer Aided Engineering (CAE) COE, and the Analytical Chemistry COE as well as with Marketing, Quality, Regulatory, Manufacturing Technology Innovation, and Operations.
The Associate Director is the functional leader of a multifunctional R&D team which includes systems engineering, design development and verification and validation engineering personnel and has ownership for the delivery of a robust technical design implementation. The responsibilities will include leading teams across multiple sites in the US and Asia.
They will also be responsible for supporting identification and partnership with the concept leader to develop and execute R&D innovation programs and strategies in support of the business to develop concepts and establish technical feasibilities of new innovative differentiated solutions for the business. This includes searching for and synthesizing new product opportunities (internally and externally) as well as identifying and guiding the solution of technical problems. This position partners with R&D, technology development, strategic innovation and the business teams to develop realizable concepts for new opportunities.
POSITION REQUIREMENTS
KNOWLEDGE AND EXPERIENCE:
OVERALL
The successful candidate will have a proven record of product development excellence and leadership in the medical device industry with a minimum of eight years of experience. In order to effectively lead strong technical teams, s/he should be well-versed in the execution of all aspects of product development including requirements management, design, development, verification and validation, transfer to manufacturing, and other aspects relevant to successful product commercialization. The candidate must have a deep understanding of systems design, mechanical design as well as materials science. S/he must also have solid R&D experience employing modern, lean product development methodologies across multi-disciplinary teams.
The candidate must be a self-starter, have a strong work ethic, and have a experience in effective change management. Experience as a creative problem solver, a passion for continuous improvement, and the ability to work independently and within a team setting are all required attributes.
The candidate will have a reputation and record of effective collaboration with peers, subordinates and superiors as well as outside advisors and customers. S/he should also have demonstrated clear history of attracting, developing, and empowering technical talent, with an emphasis on building engineering competencies, technical excellence and engineering robustness. The candidate will have earned an undergraduate degree in engineering or similar technical discipline. An advanced degree in engineering will be advantageous.
Education
- BS degree in Mechanical Engineering, Materials Science and Engineering, Biomedical Engineering or a closely related engineering degree required. An advanced degree in a complimentary engineering discipline and/or an MBA are preferred.
- At least 8 years relevant experience in concept and product development and design with at least 5 years product development and design experience in medical devices/products is preferred.
- Successful track record of developing new medical device products, including multiple successful end-to-end product development cycles for complex medical systems.
- Successful track record of commercializing new medical device products.
- Development and implementation of design and development plans based on business needs.
- Successful track record of identifying new opportunities, developing concepts, and transferring product concepts into product development.
- Successful track record of commercializing new products.
- Business acumen to align innovation actions with business objectives, knowledge of business context and goals, finance and marketing knowledge, knowledge of legal agreements and IP processes.
- Technical organizational development, including a strong track record of attracting, mentoring, developing, and empowering technical talent.
- Demonstrated development and implementation of R&D organizational tools, processes, standards and metrics, including establishment of best practices.
- Demonstrated hands on R&D impact as an individual contributor in product development.
- Demonstrated ability to develop and evaluate business case assumptions.
- Interaction and successful negotiations with external partners.
- Mechanical design and development including computer aided modeling and simulation.
- Demonstrated customer focus and engagement.
- Development and maintenance of product and technology roadmaps along with intellectual property management.
- Leading and managing product development for concepts, new product development and product engineering.
- Project planning and resourcing. An ability to articulate the level of resources necessary to execute product development projects successfully.
- Development of project and product requirements.
- Demonstrated hands on R&D impact as an individual contributor in product development.
- Demonstrated ability to develop innovative ideas to solve complex problems and reduce them to practice.
- Deep understanding of disciplined product development through phase gate processes, regulatory and quality requirements, as well as high-volume manufacturing experience.
- Exceptional written and oral communication skills required. Experience leading global teams is a strong plus.
- Demonstrated cross functional problem-solving skills.
- Budget development and management.
- Organizational planning and development including resource planning and hiring.
- Successful track record of organizational development including acquisition and development of talent.
- Self-initiator, results driven and action and detail oriented.
- Design for Reliability (DFR), DFSS, DMAIC, and/or Agile development methodologies preferred.
- Ability to partner with business leadership and align actions in the R&D organization to meet the objectives.
- Business acumen is required to align R&D actions to business objectives and strategies.
- Ability to participate with other leaders to contribute to establishing strategic business plans and objectives.
- Ability to identify, break down and solve deep technical problems.
- Ability to influence senior level leaders regarding matters of significance to the organization.
- Ability to work independently and think strategically.
- Disciplined and well organized.
- Able to effectively lead change efforts with limited resources.
- Demonstrated learning agility of new subject matter.
- Ability to act as a change protagonist.
- Ability to manage ambiguity and consolidate disparate thoughts into a single message.
- Demonstrates strong intellectual horsepower: Intellectually sharp, mentally quick, and deals with concepts and complexities better than most.
- Demonstrates exceptional emotional intelligence: High understanding of self and others; excellent "people" and influence skills, including under conditions of stress, pressure or conflict.
- Clear in presenting their viewpoints and thinking. Simplifies complex issues and ideas so others can more easily understand them.
- Excellent...
