Responsibilities

This role supports manufacturing operations in the areas of process development, tool design, machine programming, machinery & equipment acquisition, manufacturing layout,

continuous improvement and other duties associated with engineering support of production.
Provides technical support in identifying continuous improvements to manufacturing

operations and implement new technologies including the development of processes,

researching the current and emerging technologies and evaluating process quality, cost, capacity, and capability alternatives.
Supports the needs of the assigned manufacturing area in terms of meeting the requirements for quality standards and compliant documentation, capacity, product availability, and cost.
Provides technical support regarding equipment design and development, testing of materials, preparation of specifications and operator instructions, process studies, investigations, root cause analysis, problem-solving, and report or presentation preparation.
Performs assignments designed to continue the development of professional work

knowledge and abilities requiring application of standard engineering techniques, procedures, and criteria in carrying out a sequence of related engineering tasks, project management, statistical analysis, and presentation of data and technical writing.
Position duties and responsibilities
Leads engineering projects that are less complex, either technically or with a small cross-functional team. Leads and participates in projects including developing and executing to the plan and schedule and meeting the goals and objectives of the project. Tracks costs, prepare status reports, conducts meetings, and documents, and communicates progress to management.
Leads and participates in investigations, develop plans, and executes tasks to solve

process problems including Nonconformances (NC), complaint investigations, audit

observations and Corrective and Preventive Actions (CAPA).
Provides day-to-day support to production such as, but not limited to turning, milling, drilling, EDM, finishing, packaging, etc. as required.
Writes and executes engineering studies and process validation protocols and summary reports (Installation Qualification, Operation Qualification, Performance Qualification, Computer Software Validation, and Test Method Validation).
Identifies and implements process improvements for existing manufacturing processes

utilizing appropriate engineering principles and standard strategies as e.g. Lean and Six

Sigma principles.
Performs gage design, measurement system analysis, and gage implementation as required. Is able to use various types of measuring instruments including, micrometers, calipers, comparators, tensile testers, coordinate measurement systems etc. to support engineering testing.
Develops fixtures and designs tools and has the ability to express and implement ideas

with tool designers.
Supports new equipment acquisition efforts including user requirement specifications,

machine selection, installation, validation, employee training, and other related equipment

Responsibilities As Required.
Develops and implements manufacturing and inspection procedures.
Participates in, and in some cases, leads cross-functional teams which may include, but are not limited to Manufacturing Engineering, Production, Quality Assurance, Finance and

Product Development.
Acts as a liaison to vendors with regard to contracted products, tools & fixtures, and

their manufacture.

Job profile

Education Requirements
Bachelor of Science Degree from an accredited institution in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, or equivalent

Experience
Minimum 2 years of experience in manufacturing and/or engineering is required.
Previous experience working in a regulated industry, such as medical devices is preferred.
Six Sigma or Lean Sigma certification or 2 years of experience preferred.

Interpersonal Skills/characteristics (if Applicable)
Demonstrates strong written, verbal, and presentation skills.
Demonstrates strong computer skills, such as the use of Microsoft Office, Minitab,

and databases.
Demonstrates strong organizational and project management skills and is results-oriented.
Demonstrates positive interpersonal skills and professional interactions with coworkers.
Demonstrates troubleshooting skills.

Other Requirements (if Applicable)
Must be willing to support global projects including some travel.
Must be willing to support all production shifts.
Participates in and understands compliance-related activities pertaining to the job assignment including compliance with the Quality System Regulation (QSR), Standard Operating Procedures (SOP), and applicable Work Instructions.
Follows all laws and policies as they apply to one’s job and maintains the highest levels

of professionalism, ethics, and compliance at all times.
Supports and operates in a proactive safety environment

Minimum Language Required
German: Good for German-speaking sites
English: Business fluent

Special Working Conditions / Security Aspects (if Applicable)
Works in conditions that may be hot, cold, wet, and/or noisy along with exposure to fumes, oil, coolants, and other manufacturing-related chemicals