Empowering people, creating technology.

Responsibilities:

• Support and develop validation protocols and reports (IQ/OQ/PQ) and provide objective evidence that equipment, processes, test methods and product meet requirements and are complaint with applicable regulations.

• Close communication with customers, production, QA, suppliers and product development teams on project matters, material issues, tooling and fixture design, process capability studies, and product quality issues for existing processes, products and related projects.

• Provides engineering support for products launching to production and resolves issues as they arise.

• Identify, initiate and leads projects to improve productivity and quality through proper investigation and data driven six sigma principals.

• Support MRB and EO/DCN(Engineering Change/Document Change Notice) received in the Manufacturing Engineering department, their rejection or approval, development and implementation of any process changes and proper documentation of any such changes

• Conceptualizes and develops lean manufacturing processes for new and existing business opportunities, which may include new and/or modified plant equipment and process needs.

• Documents and adheres to Design Control and Risk Management requirements for modified medical device products, complying with applicable Quality System Requirements including ISO 13485, ISO 14971 and CFR Title 21.

• Conducts design verification and validation of modified medical device products to ensure consistency of the design outputs against the requirements.

• Maintains and modifies design history files and technical files in accordance with Design Control procedures.

• Maintain a vigilance to identify new potential technologies for the company.

• Participate in internal audits and assists with maintaining the Quality System to ISO-13485 standards.

Qualifications:

• Bachelor of Science in Mechanical, Manufacturing, Industrial Engineering. EIT or PE a plus.

• Any experience as a process, validation, or manufacturing engineer in a manufacturing environment is preferred.

• Experience in silicone, plastic, or rubber extrusion or molding manufacturing a plus.

• Strong interpersonal, oral, and written communication skills with the ability to effectively communicate within the organization, and with customers and suppliers as required.

• Ability to provide accurate inputs for the preparation of project timelines and estimates.

• Proficient with use of Microsoft Office applications including Word, Excel, Visio and PowerPoint. Proficient with use of SolidWorks 3D CAD software to create solid models and engineering drawings. Able to learn and use MRP systems; SAP preferred.

• Ability to utilize metrology equipment such as pin gauges, calipers, micrometers, CMM, etc

• Ability to learn and use a variety of problem solving methods to find solutions to complex engineering problems, root cause analysis, fault-tree analysis.

• Must possess a hands-on mechanical aptitude.

• Any experience in a structured regulatory environment with advanced quality systems such as ISO13485, FDA CFR 21, ISO 9001, AS9100, TS16949, or equivalent preferred.

• Certifications in LEAN manufacturing, SPC, or Six Sigma technique a plus.

The Freudenberg Group is an equal opportunity employer that is committed to diversity and inclusion. Employment opportunities are available to all applicants and associates without regard to race, color, religion, creed, gender (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender identity or expression, national origin, ancestry, age, mental or physical disability, genetic information, marital status, familial status, sexual orientation, protected military or veteran status, or any other characteristic protected by applicable law.

Freudenberg Medical LLC ID:uDnQdo