Sr. Manufacturing Engineer

Position summary

The Manufacturing Engineer Ill will be responsible for leading the manufacturing of product and implementation of improvements including cost, manufacturability, and quality goals. Responsible for planning, designing, developing, and maintaining programs, training, and manufacturing processes such as: machining, packaging, welding, assembly, and molding. 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.

Essential Job Functions

· Initiate and complete technical activities leading to new or improved processes for current and next generation programs and to meet strategic goals and objectives of the company.

· Execute and document Equipment and Process validations.

· 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

· Maintain and approve device routers and bill of materials

· Monitor performance of equipment, machines, and tools and corrects equipment problems or process parameters that produce non-conforming products, low yields, or product quality issues

· Maintain and approve manufacturing procedures

· Design and coordinate fabrication and implementation of process fixturing or gauging

· Resolve non-conformances and participates on Material Review Board

· Analyze and map processes, assesses efficiency, and implements complex project activities

· Create new part numbers and methods in the ERP

· 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

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

· Valid passport and U.S. visa

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

· Minimum of 7 years of engineering experience in a manufacturing setting; including state of the art manufacturing technology/concepts and cost reductions

· Manufacturing process design and validation

· Experience in an ISO13485/GMP environment

· Engineering experience with medical devices

· Lean manufacturing experience

· Knowledge of materials and related processes

· Project management experience

· DOE, SPC, FMEA, GMP, QSR

· 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

· Knowledge of Statistical Tools and Data Analysis

Desirable Criteria & Qualifications

· Experience working in contract manufacturing medical device companies

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

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

· Knowledge of statistical software

· Manufacturing equipment and fixture/gauge design

· Manufacturing automation, including electronic visual inspection

· 3D CAD software (i.e. ProE, Unigraphics, SolidWorks, etc.)

· Knowledge in Epicor