Project Engineer - Danbury
Bethel , CT 06810 US
Title: Project engineer
Hiring Organization: Connexion Systems & Engineering
- Duration: Temp to Perm
- Pay rate: $50-60/hr
- Job Location: Bethel, CT
- Job# 15140
Essential Duties and Responsibilities:
The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.
- Develops, writes, and executes process validations (IQ/OQ/PQ) on manufacturing processes and in process test equipment for capital medical device equipment.
- Develops, writes, and executes Test Method Validations (TMV) on in process tests and inspections.
- Gives input to the creation of process flowcharts, Risk Files & Process Control plans.
- Risk management team member to ensure that all Process Risks (PFMEA) are accounted for and proper mitigations are in place. Develops validation methods to account for identified process risks.
- Acts with urgency to identify, diagnose, prioritize, and resolve project and technical issues as they relate to validations and risk mitigations.
- Works cross functionally with other departments to represent Operations in the NPI process.
- Conduct process analyses and use statistical techniques and risk-based decisions to analyze data. Prioritize and leads activities such as process failure reviews, Kaizen events and process enhancement activities aimed at improving quality, reducing cycle time, and reducing cost.
- Work with Manufacturing to ensure assembly procedures and manufacturing test procedures are validation ready.
- Create and manage Engineering Change Order documentation including validation data, protocols, and reports within company’s Quality Management system.
- Create additional manufacturing documentation as needed to support New Product Introductions.
- Assist with gathering and documenting equipment and test requirements for components and assemblies.
- Interact with team leader on project status and resolution of critical issues; Promptly escalate unresolved dependencies and issues, which affect product delivery and quality that are beyond scope of influence.
- Learn and adapt to QMS and work closely with Engineering cross functional teams
The physical requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
- Sit; use hands to finger, handle or feel objects, tools, or controls.
- Stand; walk; reach with hands and arms; and stoop, kneel, crouch, or crawl.
- Education: Bachelor’s Degree in Technical Area of Study
- May have a Master’s Degree
- 2-5 Years of Experience with bachelor’s degree in Technical Area of Study
- 1-3 Years of Experience with master’s degree
- Excellent written and verbal communication skills. Adapts communication style to suite different audiences. Creates precise, accurate technical documentation. Able to facilitate group discussions.
- Strong knowledge of process validations (IQ/OQ/PQ) in a manufacturing environment preferably FDA regulated
- Strong knowledge of Good Documentation Practices (GDP)
- Strong knowledge of Test Method Validations
- Knowledge of statistical techniques such as process capability (cpk/ppk) and statistical process controls (SPC)
- Strong contributor to a high performing team
- Advanced knowledge of MS Office
- Ability to meet project deadlines and fluidly transition between multiple simultaneous projects
- Understanding of medical device compliance, standards, and regulations
- Working knowledge of manufacturing, quality improvement and cost reduction methodologies such as CIMs, Lean, Root Cause and Root Cause Failure Analysis, SPC and Six Sigma
- Basic knowledge of SolidWorks
Please use the apply button to submit your resume for consideration. A Connexion Representative will contact you immediately.
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Meet Your Recruiter
Regional Recruiting Manager
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