THE JOB OPPORTUNITY:

The Manager will lead the Instrument Operations technical group that is responsible for i-STAT 1 hardware system on market support. In this role the Manager will ensure that processes and staffing are appropriately developed and implemented, set strategic vision/goals in alignment with organization, drive utilization of engineering tools including root cause analysis, design for manufacturability, and LEAN to improve manufacturing processes, yields, and equipment during the manufacturing stages of the product and ensure executional compliance within the organization to all applicable internal requirements and external regulations.

THE JOB RESPONSIBILITIES:

• Manage and resolve manufacturing process, equipment, material, and supplier technical issues to maintain production line up time.
• Laisse with Third Party Manufactures in Asia on a weekly basis.  This typically involves 2-3 evening conference calls per week.
• Analyze data and make decisions regarding manufacturing processes, product performance, and quality related events.
• Provide technical input to the Supply Chain when a supplier must be selected or changed or when a last time inventory buy is needed.
• Manage the identification and qualification of end-of-life BOM components to ensure availability of raw materials.
• Utilize knowledge and skill to lead an organization through resolution of technical challenges, process/equipment improvements, and continuous improvement.
• Provide technical guidance when requested to resolve component incoming inspection failure resolution by assessing inputs from Quality, Supply Chain, and the supplier.
• Ensure professional project management techniques are utilized to identify and shorten the critical path tasks in Design Change Package (DCP)/project delivery schedules.
• Ensures that the engineering group plans and executes on market product DCPs and on market product support engineering tasks to timeline and budget.
• Coordinates across functional areas and or business units to achieve company and/or area goals.
• Manage change planning integration with the Manufacturing Software Engineering department to ensure smooth software deployment to manufacturing lines.
• Make decisions regarding work processes or operational plans and schedules to achieve department objectives.
• Provide cross-functional communications regarding the status of department and manufacturing performance.
• Liaise with suppliers to ensure the success of critical projects.
• Review and approve documents including standard operating procedures, technical specifications, and protocols/reports.
• Champion a culture of teamwork, communication, and recognition.
• Recruit, manage, coach, and develop engineering and technical talent.
• Develop, monitor, and adjust the annual budget for the engineering department.
• Ensure that continuous improvement is a strong focus for staff via continuous capacity improvement, lower non-conformance rates, and elimination of both time and material waste.
• Ensure widespread adoption of best practice manufacturing engineering practices such as design for manufacturability, PFMEA, and business excellence.
• Improve supplier process capability for custom BOM components to ensure continuity of supply.
• Establish department goals, tracking, and reporting KPIs, and drive continuous improvement efforts.
• Ensures organizational compliance with company policies/procedures and regulations.
• Serve on Design Change Control Board to categorize change package requests and authorize advancement.
• Interface with external agencies during site audits.
• Negotiate complex quality issue resolution with Quality System leadership and sets strategy approach for the department’s quality system nonconformance records.
• Ensure that all personnel and team members’ training is up to date and in compliance.
• Support a culture that embraces the safety of the work environment and the safety of our customer’s patients by compliance with company EHS procedures, policies, and GMP requirements.
• Derive, defend, and adhere to the annual budget for overhead headcount and expenses, project expenses, and capital required to maintain manufacturing operations and implement the necessary cost improvement, supply continuity, product lifecycle management, and regulatory driven changes needed to support the business.

EDUCATION AND EXPERIENCE:

Required:

• Bachelor's degree in Engineering, specifically Mechanical, Electrical, Biomedical or equivalent experience.
• 9+ years of relevant work experience in a regulated industry or equivalent which includes 5+ years managing technical team (direct or dotted line, 2+ years in design control and product
• documentation (Bills of Material, Work Instructions, Drawings, Incoming Inspection) systems, and 1+ year working with Project Management concepts and tools.
• Experience in appropriate business disciplines (such as quality, operations, engineering) with organizations engaged in the manufacture of FDA regulated products.
• Strong analytical/technical knowledge and skills to lead organization through collation and analysis of manufacturing data and creation of strategic and tactical plans to achieve goals, drive continuous improvement, and address system, equipment, and process issues.
• Effective communication skills and experience influencing cross functional organizations such as R&D, Operations, Quality, and other disciplines to achieve project, business, and/or company goals.
• Ability/experience to execute and mentor others on the utilization of technical tools such as root cause analysis, LEAN, and six sigma.

Preferred:

• Strong organizational skills to lead team/department to achieve diverse set of goals and quality system output requirements.
• Management experience with technical resources and proficiency in the development of employees with diverse backgrounds and experience.
• Experience with the manufacture or design of electro/mechanical products.
• Excellent presentation skills.
• Operational experience in a medical device manufacturing environment.
• Knowledge of MRP (Manufacturing Resource Planning) system.
• Familiar with a variety of production concepts, practices, and procedures.
• Demonstrated aptitude for engineering principles and manufacturing systems.
• Strong MS Office (Excel, PowerPoint, and Word) skills.