Strong leadership, influencing and negotiating skills
Preferred:
Advanced degree (technical or business) or trades background
Management experience of engineering teams
Prior experience in discrete medical device manufacturing
Prior experience leading projects with external design, development and manufacturing partners
Knowledge of available design tools such as SolidWorks software
Skills & Competencies:
Demonstrated ability to prioritize tasks and lead a varied workload
Able to lead technical individuals and assist with complex problem solving using engineering principles
Excellent verbal and written communication
Developing effective technical and business presentations
Managing resources in a dynamic environment
Demonstrate strong leadership, management, and team work qualities
Expertise in equipment design and build, working knowledge of IQ/OQ/PQ validations, product line design and build
Ability to perform capacity planning and budgeting
Physical Requirements:
Must be able to work at a desk or remain stationary for extended periods of time
Must be able to access and navigate all areas of the facility, including clean rooms
Ability to operate a computer and other office equipment, such as printer, telephone, etc.
Ability to travel up to 30% domestically and internationally
RESPONSIBILITIES:
Provide project(s) and technical leadership to engineering development team for creation of processes and equipment as well as assembly line design to comply with medical device regulations
Establish and drive detailed equipment plans, define risks and recommend contingency plans
Establish and foster strong collaborative relationships with external design/development, manufacturing partners and service providers
Lead internal advanced development function aim at fast turn prototyping, fixture development and machining capabilities
Participate in the operational planning activities ensuring alignment to manufacturing strategy
Promote visibility and transparency of information within engineering development to accelerate decision making, obtain alignment, and increase foundational knowledge and output
Identify appropriate manufacturing strategies that match Enable product and pharma partner goals
Understand and follow the Enable procedures with a focus on quality
Manage overall project risk through comprehensive mitigation assessment and planning techniques and be responsible for working with partners to develop plans and project risk analyses
Communication includes: departmental, cross functional and project / program information as well as any status updates as needed
Define key project and manufacturing constraints such as scope, schedule, budget, resources and risks
Clearly communicate roles, expectations and accountabilities to team members on a regular basis
Serve as the lead contact for all internal partners regarding engineering development activities and establish and maintain relationships with all partners as needed
Be responsible for creation and approval of engineering budget (as appropriate)
Liaise with functional managers or partners as needed to ensure development goals are achieved and lead teams and work with management to resolve resource gaps
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