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About the Role
The Senior Manager of Engineering will manage a team in its efforts to develop, support, and maintain products and manufacturing processes for medical device instruments in an FDA regulated manufacturing environment.
Responsibilities
- Lead, own and be accountable for complex Engineering projects across all phases of planning, implementation and production readiness and support.
- Report status of key project deliverables including delays, constraints and other issues to the Project Review Board committee.
- Lead Problem Solving Teams in the failure analysis, root cause investigation, and corrective and preventative action activities for customer complaint resolution and internal manufacturing defect resolutions ensuring feedback and corrective action communication and implementation is consistent with customer expectations.
- Ensure closure of site corrective actions within timing goals.
- Collaborate across all the functional areas (R&D, Marketing, QA/QC, Regulatory, Clinical, Operations, Service and others) necessary to insure successful project completion and delivery.
- Track all current and incoming resource requirements and works with Engineers and Management to prioritize deliverables.
- Anticipate, identify, document and manage key program risks; propose and drive appropriate mitigation and contingency plans.
- Lead teams to define and prioritize scope, objectives, and requirements.
- Demonstrate and utilize knowledge of current industry best practices and implement strategies based on best practices.
- Provide technical leadership and mentor direct reports.
- Build effective relationships with core and extended team members, functional managers, senior management, and customers.
- Develop ROI data in coordination with operations personnel for equipment replacement and coordinate its design, purchase or construction, and implementation with emphasis on design of fixtures.
- Coordinate activities to ensure departmental compliance to all Federal, State, Local and Company regulatory requirements.
- Perform these and other duties as necessary or required, the inclusion of which will not alter the basic scope of the position.
Requirements
- Experience in developing customer and product requirements, translating requirements into systems level architecture designs and interface design definitions, and requirement allocation.
- Requires significant cross-functional coordination, excellent written and communications skills, and the ability to drive collaborative discussions and decisions with all key stakeholders.
- Strong hands-on skills in complex system design, integration, testing, and troubleshooting.
- Familiar with quality management system, product safety analysis, risk assessment and mitigation.
- Knowledge and experience in, ECR/ECO process, Cost analysis, value streaming, project management process monitoring and Fixture/Tool designs.
- Project management and leadership skills with an ability to collaborate with cross functional departments such as R&D, Product Management, and Process Engineering.
- Experience in medical device development.
- Excellent analytical and problem-solving skills in mechanical systems.
- Must be 18 years of age.
Skills
- AutoCAD
- strong Microsoft Office
- ERP systems skills (Oracle desired)
- Six Sigma Black Belt and Lean Manufacturing certification or experience also desirable
Location
- remote
Work Type
- full-time
Experience Level
- 8+ years of relevant experience
- 5+ years of Management experience
- A minimum of 4 years of high-volume manufacturing related experience in manufacturing facility with demonstrated skills in effective management, planning, supervision, administration and associate relations.
- Prefer background in Injection Molding and/or Medical Device manufacturing environment
Education Level
- Bachelor’s degree from an accredited college or university (Engineering, Technology, or STEM)
- Black Belt certification or ability to obtain Black Belt certification
About the Company
- We manufacture the critical IV solutions providers count on to deliver consistent, reliable care.
- Each product we make helps ensure patients receive the therapies they need without disruption.
- When you work here, you become part of something bigger—a team dedicated to reliability and innovation.
- No matter the role, your work directly strengthens the healthcare supply chain and impacts patients nationwide.
- We offer opportunities for growth, collaboration, and meaningful contributions, all in pursuit of a mission that truly matters.
- Join us and help shape the future of IV solutions.
Equal Opportunity
- Otsuka ICU Medical is committed to being an Equal Opportunity Employer.
- We ensure that 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.
- If you are an individual with a disability and need reasonable accommodation to participate in the employment selection process, please contact us at austinhr@icumed.com.
- We are committed to providing equal access and opportunities for all candidates.