At Jabil, we empower the brands who empower the world – it’s our reason for being and the guiding force that’s driving us to become the most technologically advanced manufacturing solutions provider on the planet.  Whether we’re serving one of the world’s biggest and best known brands or the coolest tech startups, our resolve never wavers. We share common desires with these brands: to make the world a better, safer and cleaner place.

***Note: Must have extensive manufacturing engineering experience within molecular diagnostics - lateral flow assay strip, reagent mixing, freeze drying, etc. ***

JOB SUMMARY

Plan, organize, and direct multi-functional engineering department to meet company objectives. Develop and maintain the processes and methods for architecture development & documentation, system design & documentation, and requirements engineering.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Communication:
·          Provide communication forum for the exchange of ideas and information with the department.
·          Assess communication style of individual team members and adapt own communication style accordingly.

FUNCTIONAL MANAGEMENT RESPONSIBILITIES

Business Strategy and Direction:
·          Know and understand the campus strategic directions.
·          Develop an understanding of the Work cell business strategy as it pertains to Engineering Services.

Cost Management:
·          Identify creative ways to reduce cost by streamlining processes and systems (i.e. modification of responsibilities or consolidation of tasks, elimination of non-value-added processes, or complete re-engineering of processes and systems).
·          Provide feedback to peers, BUMs and Director Engineering Services on cost and cost trends.

·          Manage creation and submission of project proposals and quotations.

Forecast Development and Accuracy:
·          Prepare timely forecasts for the department.
·          Compare forward forecast results to historical actual results for trend assessment and analysis.

TECHNICAL MANAGEMENT RESPONSIBILITIES
·          Guide and oversee the development of systems/products to maintain the consistency and integrity of the architecture.
·          Lead the development and implementation of platform and product architectures in collaboration with senior technical staff.
·          Guide and oversee the development of system component requirements, interfaces, and specifications necessary to maintain the consistency and integrity of the architectures.
·           
·          Analyze new components and development tools and provide guidance on their use.
·          Analyze technology trends, HR needs and market demand to plan projects.
·          Confer with management and production staff to determine engineering feasibility and cost effectiveness.
·          Adhere to all safety and health rules and regulations associated with this position and as directed by supervisor.
·          Comply and follow all procedures within the company security policy.
·         May perform other duties and responsibilities as assigned.

JOB QUALIFICATIONS
KNOWLEDGE REQUIREMENTS

·              Knowledge of FDA GxP, 21 CFR Part 820, 803, 806, 210, 211 QSR, ISO 13485, ISO 9001 and global regulatory standards required. Lyophilization of Parenteral (7/93) standards.

·              Excellent problem-solving and analytical skills. Ability to work with mathematical concepts such as

probability and statistical inference, and fundamentals of geometry and trigonometry.
·              Excellent working knowledge of up-to-date domestic, international, and company regulatory compliance.
·              Strong proficiency in determining operational requirements to enable company’s business goals and

objectives with ability to devise and implement strategy to achieve targets.
·              Strong financial and analytical ability. Proficiency in managing business analytics to determine optimum

company footprint.
·              Strong knowledge of international direct and indirect taxes as well as global customs regimes.
·              Proven track record of successful change management accomplishments, implementing and management

continuous productivity and cost reduction programs.

·              Ability to work independently, taking responsibility for the management of processes, projects and timelines.

·              Ability to influence and lead change across Groups and Divisions to implement new programs, policies and

processes.

·              Ability to author standard operating procedures and company policies

·              Ability to drive results in a matrix organization, especially having representatives from different cultures

come together, embracing diversity.

·              Strong demonstration of leadership capabilities with experience in leading programs and projects.

·              Ability to interface with technical resources and scientifically based teams

·              Familiarity with compliance IT systems
·              Strong technical writing experience required.

·              Knowledge of assembly automation techniques for Lateral Flow Assay devices.

Knowledge of Diagnostic Device Manufacturing Processes

• Lyophilization processes – pellets, membrane


• Reagent filling, Reagent inspection, Nitrogen purging


• Sealing techniques with barrier materials


• Leak testing.

·              Strong technical writing experience required.

·              Project delivery of assembly automation systems to Health Care facilities

EDUCATION & EXPERIENCE REQUIREMENTS

·              Bachelor of Science Degree or equivalent in STEM technical subject matter required (e.g. Chemistry,

                Biochemistry,Biology,etc.). Master’s Degree preferred (not MBA)

·              A minimum of 15 years professional manufacturing experience (minimum 10 years in leadership role) with

                competency in the areas of in vitro diagnostics products (IVD), research & pharma.

·              Recognized expert with a proven track record of 10 or more years managing and delivering best practices in

the IVD technologies in large, complex, global organizations
·              Extensive experience implementing, interpreting, and providing guidance on domestic and international

regulations for IVD partnering with functional stakeholders and experts.

·              Proficiency in use of industry standard enterprise systems i.e. ERP, MES, PLM, QMS & hands on experience in smart manufacturing capability i.e. IIoT (Industrial Internet of Things)

·              Or a combination of education, experience and/or training.

Jabil, including its subsidiaries, is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, religion, national origin, sex, sexual orientation, gender identify, age, disability, genetic information, veteran status, or any other characteristic protected by law.