Manager, Manufacturing Engineering

Job Description:

SUMMARY: This position oversees the development and implementation of manufacturing processes to maintain proper product functionality as well as cost efficiency. Ensures the engineering team and other manufacturing areas work together. The position is responsible for the development of equipment to aid in the manufacturing process. Reviews, evaluates and implements engineering changes and specification requirements.

SCHEDULE: Monday - Friday 8:00 am - 5:00 pm.

ESSENTIAL DUTIES AND RESPONSABILITIES include the following. Other duties may be assigned.

• Resolves personnel problems by analyzing data, investigating issues, identifying solutions, recommending action.
• Responsible for ensuring compliance with all company regulations, policies and procedures for the Quality System compliance.
• Responsible for ensuring compliance with all company regulations, policies and procedures for Health, Safety and environment compliance.
• Manage and direct the activities for the Manufacturing Engineering departments across multiple manufacturing areas.
• Develop and retain a high performing team through effective hiring, coaching, performance management, and training.
• Leads the root cause and corrective action process for quality issues across the catheter manufacturing. Works cooperatively with other departments to identify, contain, document, implement and communicate root cause and corrective actions for quality issues.
• Identify manufacturing process and equipment improvement opportunities, implement solutions, and ensure benefits are realized and results effectively communicated.
• Write / Review internal technical reports.
• Collaborate with R&D efforts to support new product introductions and ensure new products are successfully transferred from prototype and scaleup to full scale manufacturing.
• Lead lean and other continuous improvement programs to improve safety, quality, service and efficiency. Support 5s and Kaizen events throughout the organization.
• Directly supports sourcing initiatives including product evaluation, manufacturing process documentation, knowledge transfer, and site visits as required.
• Responsible for ensuring personal and company compliance with local and company regulations, policies and procedures for Health, Safety and Environmental compliance.
• Responsible for the purchase or design of equipment that meets health, safety and environmental standards set by the company.
• Responsible for performing design reviews and pre-validation assessments to ensure the safe and environmentally sound start-up of new processes
• Other duties may be assigned to meet business needs.

SUPERVISORY RESPONSIBILITIES.

Have supervisory responsibilities: Yes

Leadership: Supervise/manage/direct the selection, training, development, appraisal and work assignments of personnel.

Supervises: Manufacturing Engineer I, II, III and Staff.

Supervision: General Direction: receive very general guidance with respect to overall objectives; work is usually quite independent of others; operate within division or department policy guidelines using independent judgment in achieving assigned objectives.

EDUCATION and/or EXPERIENCE:

• Bachelor's degree in engineering is required, 7-8 years of experience in supervisory and leadership roles (required).

• Knowledge in medical industry standards (required).

• Good written and oral English communication skills (required).

• Demonstrated capacity to lead multidisciplinary teams (required).

OTHER SKILLS and ABILITIES:

• Ability to work in a self-managed work team environment.

• Ability to work different work schedules.

• Proficient personal computer skills including electronic mail, record keeping, routine database activity, word processing, spreadsheet and graphics.

• Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.

• Ability to write reports, business correspondence, and procedure manuals.

• Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.

• Ability to work with mathematical concepts such as probability and statistical inference.

• Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.

• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.

• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

MANUAL DEXTERITY: Manual dexterity sufficient to reach/handle items and work with the fingers.

VISION REQUIREMENTS: No special vision requirements

WORK SCHEDULE/HOURS: Monday – Saturday.

TRAVEL: Occasional.

ENVIRONMENTAL WORKING CONDITIONS: Well-lighted, heated and/or air-conditioned indoor office setting with adequate ventilation.

PHYSICAL DEMANDS: Sedentary physical activity performing non-strenuous daily activities of an administrative nature.

Other physical working conditions: Moderate noise.