Manufacturing Project Engineer
1 week ago
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's 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.
- 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 the company target goals.
- Assist with corrective/preventive action planning and implementation.
- Enforce strict change control requirements with the CM as defined per the CM Quality Agreement.
- Keep the company Quality informed of any developments that come up as appropriate.
Job Requirements:
- Bachelor's degree or higher in Mechanical/Manufacturing Engineering or related discipline.
- 2+ years of project management/manufacturing engineering experience in the medical device industry supporting a FDA Class III medical device.
- Experience working with/in a 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.
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