Demo

Technical Instrument Support Manager

Abbott
South Portland, ME Full Time
POSTED ON 1/25/2025
AVAILABLE BEFORE 4/17/2025

The Opportunity

The Technical Instrument Support Manager works out of our South Portland, Maine location within the IDDM Infectious Disease Developed Markets Division.

What You’ll Work On

  • Product engineering group technical lead. Drive technical design reviews for hardware, PCBs, Mechanical assemblies, Software and requirements documents.
  • Responsible for the development of project plans and schedules covering all engineering activities (Meeting all Design control and product development SOP requirements). Plan and drive the design, implementation and execution of the product lifecycle roadmap. Drive daily progress, as well as plan / maintain out to 24 months for strategic and supply considerations.
  • Manage cross functional engineering teams developing meter products. Communicate effectively and participate on a cross functional design team.
  • Develop manufacturing test specifications including ICT, functional, and final test. Conduct and participate in design specification reviews. Manually verify test processes prior to implementation using common electrical test equipment.
  • Specify and validate manufacturing test processes for medical monitoring instruments in accordance with applicable regulatory standards. Utilize statistical methods for determining variation and performance of test equipment.
  • Coordinating pilot builds, acceptance, and transition to production activities with US and OUS Contract Developers and Manufacturers.
  • Act as the manufacturing liaison to the product development team. Act as lead to resolve manufacturability issues for new and existing products. This support will include internal and external manufacturing activities.
  • Plan and execute verification and validation testing for design changes of on-market instruments.
  • Identify and implement alternate sources for obsolete parts.
  • Familiarity with documentation control tools and writing Engineering Change Orders, as required.
  • Strong knowledge of defined development process that is consistent with ISO, FDA or any recognized quality standards and requirements.
  • Responsible for implementing and maintaining the effectiveness of the quality system. Own and drive the closure of quality events, deviations and CAPA’s.
  • Lead the technical instrument support team, provide mentoring and technical guidance.
  • Responsible for project delivery on time and within budget.
  • Drive gross margin improvement from technical solutions.
  • Responsible for Product Engineering process improvement. Identify and own implementation of method-based culture for problem solving
  • Functional supervisor of the product engineering group responsible for staffing and maintaining the groups high level technical competence. Implement sustainable measurement and reporting structure and governance in the technical organization.

Required Qualifications

  • B.S. in biomedical, electrical, or mechanical engineering discipline
  • Minimum ten years total experience in supply chain, finance, engineering and analytics
  • Experience leading people (direct and indirect), preparation and delivery of presentations to senior stakeholders, audit and inspection readiness, business process mapping / optimization and cost improvement.
  • Experience with Third-Party (Contract) Manufacturers and other external resources
  • Direct manufacturing, or manufacturing support, experience
  • Experience with FDA, ISO design control standards
  • Preferred Qualifications

  • Experience in managing small engineering teams supporting point of care diagnostic products
  • Experience with the product lifecycle – from transferring new products to market through sunset
  • Proficient in understanding hardware and software interfaces and their impact to the customer experience
  • Experience in leading global process change management projects / initiatives
  • Experience in working with supply chain and manufacturing to achieve business goals and drive results in a dynamic business environment
  • Experience with SAP or equivalent
  • B.S. in biomedical, electrical, or mechanical engineering discipline
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