Our client, a healthcare manufacturing organization is seeking a Senior Manager of Engineering that reports to the Managing Director.

The ideal candidate must demonstrate meticulous attention to detail, lead others in a team environment, motivate and drive team members, breed departmental accountability, define clear targets, and effectively communicate results and data interpretation to all team members.

Candidates must have a strong ability to conceptualize and refine a product's design and drive the successful and timely introduction of new products into production.

Must be comfortable with planning, budgeting, and documenting all aspects of the current tasked project.

This position's primary focus will be to identify and lead the Engineering team and department's duties, including the design, research, prototyping, engineering documentation, estimating, and process improvement. Applicants must have proven success in leading and officially delivering the development of platforms for various applications within the genomics field. This position will require the ability to lead multi-disciplinary groups as well as cross functions for the timely completion of projects. Additionally, the candidate is expected to be experienced in systems architecture, requirements management, electro-mechanical design, fluidics, stepper, and servo motor controls.

• Manages and oversees the assignment of tasks and workloads by selecting individuals who are most qualified for assignment on specific projects.
• Understand the voice of our customer's needs and translate those into details for a new project pipeline
• Direct the technical organization to ensure progress according to technical objectives, within budgetary and schedule guidelines.
• Technical lead for product innovation and innovation strategy. Identify IP opportunities.
• Accountable for all phases of product development, including concept, planning, development
• Manages a wide range of projects from medical devices to production equipment at any point in the development cycle from ideation through manufacturing.
• Manages project, workstream, and team dependencies and risks while optimizing for constraints; along with Project & Product Management, monitors the project status at the engineering level and aggregate this into project management level reports.
• Establishes metrics, templates, and milestones for projects, including Key Performance Indicators (KPIs), and track progress and dependencies
• Manages a team of Mechanical Engineers, Electrical Engineers, and Software Engineers on projects, including outside contractors.
• Develop Talent Pipeline
• Lead the team to determine design feasibility, evaluate design alternatives, and select an optimum design approach.
• Design for manufacturability (DFM) - Guides manufacturing in the transition from development into production.
• Lead technical reviews to evaluate and analyze designs to assure performance and requirements are met.
• Ensure electrical design and documentation complies with medical safety and EMC/EMI standards.
• Accountable for R&D Design History File (DHF) deliverables according toCompany’s Design

Control Process following ISO 9001 regulatory standard (product requirement specifications, technical feasibility plan/report, risk control record).

BASIC QUALIFICATIONS:

• BS with 10 years, in relevant engineering with industrial experience in life science / molecular diagnostics,

automated liquid handling field.

• 5 years applied experience in managing a team of Engineers in a design and manufacturing environment certified to ISO 9001 / ISO 14001

PREFERRED QUALIFICATIONS:

• MS with 5 years applied experience preferred
• Advanced experience in CAD design of mechanical systems in SolidWorks (v2019 or newer).
• Proven ability to deliver projects onsite and within budget
• Track record of in-depth understanding of liquid handling automation technologies.
• Hands-on electro-mechanical systems design and troubleshooting experience.
• Experience in designing smart motion control solutions using motors, pumps, valves, linkages, actuators, and sensors.
• Knowledge of vibration, temperature, and shock testing.
• Familiar with GD & T practices.
• Experience with PLCs and related software systems.
• Programming knowledge as it pertains to automation and systems integration.
• Understanding of electronic document control systems (PDM).
• Detail-oriented approach to design, including BOM and drawing accuracy
• Track record of RUO product launches (IVD a plus) in Life Sceincesor Medical Devices.
• Strong organizational and interpersonal skills.
• Strong sense of ownership, self-starter
• Strong verbal and written communication skills.
• Ability to work in a fast-paced environment

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