Senior Engineering Manager

Otsuka ICU Medical•Austin, TX

6d•Hybrid

About The Position

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.

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; 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
Bachelor’s degree from an accredited college or university (Engineering, Technology, or STEM)
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.
Must be 18 years of age

Nice To Haves

Medical Device experience a plus
Black Belt certification or ability to obtain Black Belt certification
Prefer background in Injection Molding and/or Medical Device 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. 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