What are the responsibilities and job description for the Sr. Technical Instrument Support Engineer position at Abbott?
The Opportunity
The Sr. Technical Instrument Support Engineer position works out of our South Portland, Maine location within the IDDM Infectious Disease Developed Markets Division. In this role, you’ll have the opportunity to work on integrated business initiatives for on-market instruments, with R&D, marketing, commercial, finance, operations, quality and regulatory. This role will work on the design, development, V&V and transfer to production of design changes to on-market instruments within our business. You’ll have a strong focus on ensuring compliance to our quality system, as well as other business and regulatory standards that apply instruments. This function will execute project plans and create deliverables for each design change initiated, ensuring successful transfer to production and manufacturing flexibility.
What You’ll Work On
- Drive technical design for hardware, PCBs, Mechanical assemblies, Software and requirements documents.
- Responsible for implementation and execution of the product lifecycle roadmap. Drive daily progress, as well as plan / maintain for strategic and supply considerations.
- 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.
- 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.
- Own and drive the closure of quality events, deviations and CAPA’s.
- Responsible for project delivery on time and within budget.
- Drive gross margin improvement from technical solutions.
- Identify and own implementation of method-based culture for problem solving.
Required Qualifications
Preferred Qualifications
