- BS in Engineering
- 2+ years of experience
- Knowledge of DFMEA and PFMEA
- Experience with Process V&V, IQ, OQ, PQ, CAPA, and TMV
- Proficiency in SolidWorks
- Familiarity with Minitab
- BS in Engineering
- 2+ years of experience
- Experience with FDA 21 CFR part 820, ISO 13485, ISO 14971, and GMP
- Knowledge of DFMEA and PFMEA
- Familiarity with process mapping and critical to quality reviews
- Experience working with statistical analysis tools including Minitab, DOE, process capability, measurement system, and confidence interval analysis
- Proficiency in PTC Creo or SolidWorks
- Understanding of CAPA, root cause investigations, and quality tools such as DMAIC A3, 5 Whys, 6 M, Ishikawa Diagram, and Pareto Charts
- Experience or knowledge of engineering drawings and GD&T
- Conduct Process V&V, IQ, OQ, PQ, and TMV activities
- Utilize DFMEA and PFMEA methodologies
- Develop and maintain design and manufacturing documentation
- Collaborate with teams on CAPA and root cause investigations
- Ensure compliance with relevant regulations and standards, including FDA and ISO requirements
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Manufacturing Engineer - North Haven, United States - Entegee
Description
Job Description
Job DescriptionRequirements:
Preferred Skills:
Responsibilities:
Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.
Equal Opportunity Employer/Veterans/Disabled
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The Company will consider qualified applicants with arrest and conviction records subject to federal contractor requirements and/or security clearance requirements.Company DescriptionSpecializes in custom automation projects, they are a major player in the world of controls and robotic solutions around the world. My client will expand anyone resume and build them to be a top performing controls engineer.