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:

• 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