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About the Role

Completes advanced engineering projects with peer input and guidance from management to increase yield, maximize capacity, reduce costs, and decrease process variability, while maintaining regulatory compliance. Acts as a specialist on complex technical and business matters with highly independent work. May assume a team lead role.

Responsibilities

• Analyzes, plans, organizes and completes projects of a very complex nature, developing scope and providing creative solutions.
• Plans, organizes and conducts technical projects, consolidating results of design elements for design review.
• Integrates subsystems and components into total systems design.
• Develops specifications from customer requirements.
• Receives general project direction and is responsible for project progress.
• Makes decisions that consistently affect multiple or critical projects and may impact external relationships.
• Delivers communications tailored to the receiver's needs to promote cross-functional collaboration.
• Brings substantive conflicts and disagreements into the open and attempts to resolve them collaboratively.
• Manages training for new and current employees on documentation, equipment use, laboratory techniques, and department procedures.
• May monitor or supervise the work of others and provide input on performance evaluations.
• Identifies opportunities, develops insights, stimulates new ideas, and implements process improvements in collaboration with internal and external partners.
• Assists with technically challenging process deviations and their resolution.
• Provides direct support to commercial pharmaceutical manufacturing and support operations with technical expertise and advanced statistical concepts.
• Provides direct project management support, including planning, securing funding, technical support, and oversight.
• Participates in start-up efforts of new equipment, software, or processes.
• Implements changes using GMP change control and validation processes.
• Reviews and provides feedback and technical/scientific support on project deliverables.
• Collaborates with center functions on product development initiatives.
• Works on special projects as they arise.

Requirements

• Bachelor’s degree required; master's or PhD strongly preferred.
• 7+ years of experience with a bachelor’s degree or 5 years of experience with a PhD.
• Possesses all credentialing requirements to perform the essential functions of the role at customer locations.

Skills

• Mastery of best practices.
• Advanced understanding of engineering discipline.
• Ability to assess work supporting product strategy and make insightful recommendations regarding priorities.
• Expertise in domain of expertise and familiarity in other areas within the team's domain.

Location

• Remote (less than 5% travel)

Work Type

• Full-time
• Sedentary role
• Professional office environment
• Occasional work in a clean room environment

Experience Level

• 7+ years with Bachelor's degree
• 5+ years with PhD

Education Level

• Bachelor's degree required
• Master's or PhD strongly preferred
• Specialties: Mechanical, Chemical, Industrial, or Biomedical engineering

About the Company

• Manufactures critical IV solutions providers count on for consistent, reliable care.
• Each product helps ensure patients receive needed therapies without disruption.
• A team dedicated to reliability and innovation.
• Work strengthens the healthcare supply chain and impacts patients nationwide.
• Offers opportunities for growth, collaboration, and meaningful contributions.
• Mission-driven pursuit of shaping the future of IV solutions.

Equal Opportunity

• Otsuka ICU Medical is committed to being an Equal Opportunity Employer.
• Ensures all qualified applicants receive fair consideration for employment regardless of race, color, nationality or national origin, ethnicity, sex, gender, religion or belief, marital or civil partnership status, sexual orientation, pregnancy or maternity, age, disability, or protected veteran status.
• Provides reasonable accommodation for individuals with disabilities to participate in the employment selection process.
• Committed to providing equal access and opportunities for all candidates.