Job Abstract

Position Summary

The Manager, Engineering provides leadership and technical support to ensure development of efficient and effective methods that support production of medical devices with highest quality in compliance with engineering specifications, FDA and GMP guidelines. This individual will provide leadership for multiple technical personnel and play a major role in projects that encompass production scale up and high-volume manufacturing.

Essential Duties & Responsibilities

· Support production and ensure the continuity of manufacturing operations. Drive root cause analysis for non-conformance, long-term corrective actions and preventive measures. Evaluate and correct systemic issues.

· Work with Manufacturing and Maintenance personnel to improve performance of manufacturing systems, i.e. yield improvements, scrap reduction, MUV reduction, cycle time improvements, ergonomic issues and maintenance needs.

· Spearhead initiatives for continuous process and lean implementations. Assess yield issues and promote design and/or selection of equipment to reduce costs and improve quality.

· Manage all stages of multiple engineering projects. Promote attainment of organizational objectives through team members.

· Provide leadership and guidance for non-routine problems requiring substantial judgment in the independent evaluation, selection and adaptation of standard engineering techniques, procedures and criteria.

· Work with vendors and internal departments to obtain necessary resources, resolve inter-departmental issues and contribute toward organizational objectives.

· Provide direct management to a team of Engineers/Engineering staff, determine priorities based on business needs and resource availability.

· Conduct project/team meetings to resolve issues, determine current status, provide information and assess changes in priorities.

· Oversee preparation of documentation associated with engineering activities to include drawings/schematics, validation/capability testing, various new and revised operating procedures. Etc. Provide reports and presentations to management as required.

· Generate timelines and milestones to bring projects to completion on time and within budget.

· Model company values and support strategic initiatives.

· Perform other related duties as assigned or required.

· This position is required to assure compliance of Company operations to all applicable laws, regulations and standards, good business practices and company documented procedures (including knowledge of all standards, government occupational health and environmental regulations and statutes related to the site).

· Engage others; promote and participate in Environmental, Health and Safety initiatives, focusing on continuous improvement.

Knowledge & Skills

· Six-Sigma Methodology (DOE, Process Capability, Gage R&R etc.).

· Lean Methodology to drive equipment and processing improvements/production efficiency.

· Knowledge of Solid Works and experience with ASME Y14.5, ISO and GD&T standards.

· Maintain thorough understanding of the clinical use/risk of the product.

· Thorough understanding of strength of materials, kinematics and dynamics, vibration, and fluid flow, as well as automation, plastic injection molding, part assembly, fixturing, testing and process control techniques.

· Knowledge of the Medical Device Industry and familiarity with associated regulations.

· Excellent problem solving and analytical ability.

Minimum Qualifications, Education & Experience

· Bachelor’s Degree in Engineering or Technology. MS or MBA desirable.

· 10 years of experience in Medical Device Engineering/Technology, with 5 years in a management/supervisory/leadership role.

· Strong injection molding, tooling and automation background.

Work Environment

· While performing the duties of this job, the employee is regularly required to talk or hear.

· This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

· Work is frequently performed in a clean room environment.

· While performing the duties of this job, the employee may be required to sit or stand for long periods of time.

· Must be able to occasionally move and lift objects of up to 25 lbs.

· Typically requires travel less than 5% of the time.

ICU Medical is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.