Position Summary:
Responsible for process enhancement and design of process equipment to facilitate production of high quality medical instruments while achieving cost reductions milestones for assembly operations in accordance with ISO 13485, MDD 93/42/EEC and FDA QSR.
Duties and Responsibilities:
Review and develop process instructions for our products.
Review and update Process FMEA to develop plans for reducing failure potential.
Analyze current product design and process to develop plan for process enhancements and equipment design/fabrication.
Design and implement validation protocols for all process changes.
Manufacturing representative on all R&D projects for high volume tooling and automated production equipment.
Provide on-going technical support to production line for process related issues.
Review design change DCOs for manufacturing impact.
Primary interface with R&D on all new design transfers to production.
Co-ordinate process development at offshore contract facilities.
Review and approve supplier process controls.
Perform all tasks in compliance with the Company’s Quality System.
Ensure the Quality Objectives are communicated to the CM/CD&Ms and provide periodic data to assess conformance to the Quality Objectives.
Other related duties which may be assigned.
Position Requirements:
Proficient with computer software: MS Office including Project, SolidWorks
Ability to work well under pressure, to handle multiple tasks, and to meet aggressive deadlines
Good analytical and interpersonal skills, ability to work independently
Education Requirements:
BS Degree or equivalent in an Engineering discipline.
Experience Requirements:
10 or more years of experience in manufacturing process engineering with working knowledge ofMedical Device requirements.
Background in demand and build planning, Supply Chain management for CM sites
Other Requirements (Plus):
Multiple Language skills are a Plus for CM sites
Preferred Requirements:
Knowledge of ISO13485 and FDA Requirements
Experience with inspecting materials, finished product testing
Experience with IQ, OQ,PQ
Experience with product complaint handling, investigation / evaluation and resolution
Note: This job description is an outline of the major recurring responsibilities of the job/position. It is not intended to be all-inclusive of the work to be performed. Other related job objectives, special assignments and less significant responsibilities will typically be performed by the incumbent. Incumbents will follow any other instructions, and perform any other related duties, as may be required by their supervisor.
