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Associate VP, Engineering and Automation (Cincinnati)
Enable Injections IncCincinnati, OH, USjob_description.job_card.variable_hours_ago
serp_jobs.job_preview.job_type
- serp_jobs.job_card.part_time
job_description.job_card.job_descriptionAdvanced 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 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 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 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
Associate VP, Engineering and Automation
Qualifications
Required :
- Technical bachelor's degree
- 15+ years of experience in development and manufacturing of medical device processes and equipment
- 7+ years of experience leading manager level personnel, teams and projects
- Experience in developing and commercializing regulated devices / combination products under FDA (21 CFR 820), ISO 13481 and ISO 14791 requirements
- Knowledge of global industry standards (ex. ISO, AAMI, ANSI, etc.)
- Strong hands-on technical leadership skills with a proven track record of equipment and automation design and implementation
- Proficiency utilizing the MS Office Suite (Project, Word, Excel, PowerPoint, Visio, Outlook)
- Demonstrated ability to prioritize tasks and lead a varied workload
- Demonstrated extraordinary problem-solving ability
- Strong leadership, influencing and negotiating skills
Preferred :
Skills & Competencies :
Physical Requirements :
Responsibilities
Nearest Major Market : Cincinnati
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