Senior Engineering Manager

Otsuka ICU Medical LLC; Austin (TX); Presencial; USD 120.000 - 180.000; Jornada completa

Descripción de la vacante

Otsuka ICU Medical LLC is seeking a Senior Manager of Engineering to lead a team responsible for developing, supporting, and maintaining medical device instruments in an FDA-regulated manufacturing environment. The role requires managing complex projects across planning, implementation, and production readiness, while ensuring regulatory compliance and robust CAPA processes.

The ideal candidate will bring extensive cross-functional collaboration experience, strong problem-solving and project

Formación

• Requires 8+ years of relevant engineering experience with 5+ years of management experience.
• Experience in medical device development or FDA-regulated environments is a plus.
• Black Belt certification or ability to obtain Black Belt is preferred.
• Minimum 4 years of high-volume manufacturing experience in a manufacturing facility, with exposure to Injection Molding or medical device manufacturing.

Responsabilidades

• Lead complex engineering projects across all phases from planning to production readiness.
• Report status of key deliverables to Project Review Board.
• Drive root cause analysis and CAPA for customer complaints and internal defects.
• Collaborate with R&D, QA/QC, Regulatory, Operations and other functions to ensure project success.
• Prioritize deliverables with engineers and management; manage resource requirements.
• Identify and mitigate program risks with contingency plans.
• Provide technical leadership and mentor direct reports.
• Coordinate compliance with FDA, EPA, OSHA, ISO and company policies.

Conocimientos

Engineering leadership

Cross-functional coordination

Problem solving

Project management

AutoCAD

Oracle ERP

Six Sigma Black Belt

Lean Manufacturing

Medical device knowledge

Quality systems

Educación

Bachelor's degree in Engineering/ STEM

Six Sigma Black Belt certification

Herramientas

Oracle ERP

Microsoft Office

Descripción del empleo

Job Description

Position Summary

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.

Essential Duties & 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. These elements include FDA, EPA, OSHA, ISO, EEOC and Company policies related to the manufacture of products, lot control requirements, documentation requirements, housekeeping, preventative maintenance, calibration, associate training and safety (equipment, associate and material).
• Perform these and other duties as necessary or required, the inclusion of which will not alter the basic scope of the position

Knowledge, Skills & Qualifications

• 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; AutoCAD, strong Microsoft Office and ERP systems skills (Oracle desired). Six Sigma Black Belt and Lean Manufacturing certification or experience also desirable
• Experience in medical device development
• Excellent analytical and problem-solving skills in mechanical systems

Education and Experience

Bachelor's degree from an accredited college or university (Engineering, Technology, or STEM) 8+ years of relevant experience to include 5+ years of Management experience Medical Device experience a plus Black Belt certification or ability to obtain Black Belt certification 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

Minimum Qualifications

Must be 18 years of age

Travel Requirements

Typically requires travel 5-20% of the time

Physical Requirements and Work Environment

While performing the duties of this job, the employee is regularly required to talk or hear. This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Work is frequently performed in a clean room environment While performing the duties of this job, the employee may be required to sit or stand for long periods of time. Must be able to occasionally move and lift objects of up to 25 lbs

About Us

Innovation, Impact, and Purpose. Find Your Future Here. 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 strengths 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.

EEO Statement

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 [e-mail]. We are committed to providing equal access and opportunities for all candidates.

Otsuka ICU Medical EEO Policy Statement Know Your Rights: Workplace Discrimination is Illegal Poster Otsuka ICU Medical CCPA Notice to Job Applicants