Our client is a US-based Medical Equipment Manufacturing company renowned for their award-winning AED and cardiac arrest response system.
Job Responsibilities: Project Management: Develop and coordinate tactical plans with CM technical staff, and regularly report status Oversee day-to-day activities at the CM with a focus on driving on-time completion of activities per agreed to schedule and commit dates.
Overcome schedule challenges and delays to keep projects on-track.
Manufacturing Engineering: Interface with contract manufacturer and US based engineering teams, representing the company interests and bridging time differences.
Exercise engineering judgement of part, process, and product issues throughout the CM facility to minimize production down time and bridge the gap until US engineering resources are available.
Read/understand, and support execution of test protocols, perform/oversee testing, and review or author reports to support test method validation (TMV), process validation (IQ, OQ, PQ), intended use validation (IUV), flowcharts, PFMEA, DOE, Gage R&R in accordance with FDA and ISO quality system regulations.
Analyze and recommend improvements to existing processes using Lean Manufacturing principles.
Read and interpret standard engineering drawings, and understand GD&T and tolerance stack up analysis Observe contract manufacturing to ensure adherence to common good manufacturing practices (CGMPs) and applicable FDA and ISO quality system regulations.
Comply with FDA 21 CFR Part 820 and ISO 13485:2016 quality system regulations used in the Medical Device Industry.
Supplier Quality: Interface with Quality group to resolve Manufacturing related issues, using different quality tools such as 5whys, cause and effect diagram, etc.
and problem-solving methodologies such as Six Sigma.
Contribute to functions outside areas of direct responsibility including but not limited to Supplier Quality and support fulfilling requirements such as supplier surveys, supplier assessments, audits, continuous improvement, etc.
Coordinate with appropriate suppliers and other external resources needed in developing and implementing process improvement plans.
Initiate/participate in weekly/monthly quality review and metric meetings and drive KPIs to meet target goals.
Assists with corrective/preventive action planning and implementation.
Enforce strict change control requirements with the CM as defined per the CM Quality Agreement.
Job Requirements: Bachelors degree or higher in Mechanical/Manufacturing Engineering or related discipline.
2+ years of project management/manufacturing engineering experience in medical device industry supporting a FDA Class III medical device.
Experience working with/in contract manufacturing environment.
"Hands-on" mechanical aptitude, engineering acumen and analytical skills Ability to read and understand engineering drawings.
Process implementation and process validation experience.
Experience with software based mechanical medical devices and products.
Solid organizational planning, communication skills, articulate, team player, dependable, able to work in a fast-paced environment with accuracy/efficiency.