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