Sr Engineering Services Manager - Molecular Diagnostics

Descripción del Trabajo

***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.