Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. We’re empowering smarter medical and economic decision making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people. Abbott Molecular is a leader in molecular diagnostics and the analysis of DNA, RNA, and proteins at the molecular level. Our Point of Care diagnostic portfolio spans key heath and therapeutic areas, including infections disease, cardiometabolic, informatics and toxicology. Our diagnostic solutions are used in hospitals, laboratories and clinics around the globe. The crucial information derived from our tests, instruments and informatics systems are often the first step in patient care decision making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers. Our rapid diagnostics solutions are helping address some of the world’s greatest healthcare challenges. As the Technical Instrument Support Manager, you’ll have the chance to lead integrated business initiatives for on-market instruments, with R&D, marketing, commercial, finance, operations, quality and regulatory. This role will drive 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 define and track the project plans and deliverables for each design change initiated, ensuring successful transfer to production and manufacturing flexibility. **Working at Abbott** At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to: + Career development with an international company where you can grow the career you dream of. + Free medical coverage for employees* via the Health Investment Plan (HIP) PPO + An excellent retirement savings plan with high employer contribution + Tuition reimbursement, the Freedom 2 Save (https://www.abbott.com/corpnewsroom/strategy-and-strength/tackling-student-debt-for-our-employees.html) student debt initiative and FreeU (https://www.abbott.com/corpnewsroom/strategy-and-strength/college-degree-for-free-its-possible-with-freeu.html) education benefit - an affordable and convenient path to getting a bachelor’s degree. + A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune. + A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists. **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 Apply Now (https://www.jobs.abbott/us/en) * Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year. **Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:** www.abbottbenefits.com (http://www.abbottbenefits.com/pages/candidate.aspx) Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at www.abbott.com , on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews. The base pay for this position is $97,300.00 – $194,700.00. In specific locations, the pay range may vary from the range posted. An Equal Opportunity Employer Abbot welcomes and encourages diversity in our workforce. We provide reasonable accommodation to qualified individuals with disabilities. To request accommodation, please call 224-667-4913 or email corpjat@abbott.com