Production & Manufacturing Engineer

Overview

Position summary

The Production & Manufacturing Engineer will be responsible for leading the manufacturing of products and implementation of improvements including cost, manufacturability, and quality goals. Responsible for planning, designing, developing, and maintaining programs, training, and manufacturing. This position will also provide direction and support for existing products, including support to the Manufacturing organization to facilitate efficient operations within the production area, to optimize existing processes and to ensure that production goals are met.

Responsibilities

Essential Job Functions

· Maintain a safe working environment by ensuring compliance with all health and safety regulations.

· Reviewing and executing production schedules and manpower requirements

· Setting and achieving performance targets for production efficiency and on time delivery

· Planning and executing training and supervising team members in the use of new production processes and equipment

· Guarantee material, tooling equipment and resources availability to meet production schedule in time and form.

· Collaborate with other departments to ensure seamless integration of production processes.

· Conduct data analysis and make recommendations for process improvements.

· Work closely with engineering, production, supply chain and quality teams to resolve production issues and ensure high-quality standards.

· Analyze and solve problems from basic engineering principles, theories, and concepts through to a wide range of complex and advanced problems which require novel and innovative approaches or a breakthrough technology

· Interfaces with quality and manufacturing to integrate new products or processes into the existing production area

· Guarantee correct report of production activities in ERP

· Provide inputs to keep optimal and updated information on routers and bill of materials

· Monitor performance of equipment, machines.

· Maintain and approve manufacturing procedures applicable the area of responsibility

· Resolve non-conformances and participates on Material Review Board

· Assist with part cost estimation

· Support and comply with the company Quality System, ISO, and medical device requirements

· Read, understand, and follow work instructions and standard work

· Partner with other business segments: sales/marketing, customer service, engineering, quality, and finance

· Understand customer needs and the core business markets we serve

· Ensure business systems are implemented, maintained, and functioning properly

· Participate in required company meetings

· Maintain an organized work area (5S)

· Participate in the Operational Excellence Program

· Complete all other work duties as assigned

· Ability to work in a manufacturing environment

Qualifications

Minimum Requirements, Education & Experience (incl. KSA’s and certifications)

· Bachelor’s Degree in Mechanical, Industrial, or other Engineering Science

· Minimum of 5 years of engineering experience in a manufacturing setting; including state of the art manufacturing technology/concepts and cost reductions

· People Management experience

· Production scheduling/training and ramping experience

· Experience in quality regulated industries

· Lean manufacturing experience

· Excellent communication and influencing skills

· High level of energy, personal accountability and integrity

· Highly detail oriented; checks own work, keeps accurate records, organizes information effectively

· Ability to tolerate ambiguity, multiple priorities, and short deadlines

· Microsoft Office proficiency (Outlook, Word, Excel, PowerPoint, Publisher)

· Clear and effective verbal and written communication skills

· Attention to detail

· Organizational skills

· Ability to work in a fast-paced team environment

· Ability to prioritize and multitask

· Knowledge of Problem-Solving Tools

Desirable Criteria & Qualifications

· Experience working in contract manufacturing medical device companies

· Experience in an ISO13485/GMP environment

· Knowledge of Statistical Tools and Data Analysis

· Continuing Education; including participation in local chapters, associations, and/or organizations

· Team dynamic skills (communication, accountability, decision-making, feedback, meeting management, managing conflict)