Job Description :
Job Summary:
Individual contributor position responsible for overseeing the planning, development, implementation and maintenance of manufacturing methods, processes, tools and operations for new and existing products, including process validation. Ensures the effective use of materials, equipment, and personnel in producing quality products at minimum costs. Acts as a liaison with engineering in releasing new products. Develops systems to maintain reports and record keeping of company products. Selects, develops, and evaluates personnel to ensure the efficient operation of the function.
In this job, you will:
Be the Engineering Process Owner for manufacturing activities/processes/equipment/tooling on the shop floor.
Support production through efficient and effective identification and resolution of line issues.
Participate in cross-functional teams during product development to ensure design for manufacturability, process development, manufacturing documentation, and pilot operations.
Properly document activities in accordance with best engineering practices, company procedures and regulatory requirements.Follow good project management practices.
Interface with external vendors to source parts, equipment and fixtures.
Interface with external vendors to resolve supplier quality and process capability issues.
Within Product Life Management (PLM) (Agile) environment:
Initiate engineering change requests (ECR) and complete engineering change orders (ECO)
Structure Bills of Material (BOM)
Initiate and / or complete non-conformance reports (NCR)
Initiate and / or complete supplier non-conformance reports (SNCR)
Investigate and complete corrective and preventive action (CAPA) assignments
Effectively train operators, technicians, and engineers on use of equipment and fixtures.
Design, develop, and verify product design changes using computer aided design (CAD) software following design control procedures.
Create and maintain medical device design documentation compliant with FDA design controls and good documentation practices
Create and maintain medical device Device Master Records
Review medical device safety testing and maintain product compliance with applicable UL, ISO, and IEC 60601 standards as well as international regulatory requirements
Review product related Corrective and Preventative Actions to ensure appropriate problem solving techniques (DMAIC, FMEA, Ishikawa, Fault Tree, etc have been used
Travel Required: Expected minimal to moderate travel required to manage suppliers, vendors, subcontractors and attend management reviews.
Bachelor''s degree (B.S in an Engineering field from four-year college or university. At least five years related experience and/or training; or equivalent combination of education and experience.
Competency in FDA Quality System Regulations, Current Good Manufacturing Practices, and ISO13485 Quality Management Systems for Medical Devices
Excellent computer skills, including Microsoft Project, Visio, and Office.
Engineering Process Owner for manufacturing and test work instructions.
Design for Reliability (DFR) and Design for Manufacturing (DFM) and design for Testing (DFT)
Competency with medical device safety standards (IEC 60601 Competency in medical device risk management (ISO 14971)
Experience with Solidworks or other CAD software a plus.
Good understanding and usability skills related to Six Sigma