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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
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