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.