Prin Quality Engineer
195 McDermott Road North Haven, CT 06473 US
Job Description
Top 3 technical skills that you are looking for in a candidates experience:
- Risk Management lead with experience in DFMECA, Critical to Quality design elements, and PPAP
- Design specification review experience with an emphasis on Geometric Dimensioning and tolerancing, Tolerance analysis, Finite Element Analysis
- Provides or directs verification and validation of device and software system requirements, traceability, and testability
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Must Have
- Creo Parametric, tool/fixture design, mechanical aptitude, print reading, dimensioning and tolerancing, technical communication
- Design Quality
- DFMEA
- Experience with ISO 14971 and medical device risk management.
- Minitab Statistical Software
- PFMEA
- PPAP - Product / Component Qualification
- Supplier Quality
- Technical Writing
Education Required: Bachelors of science in an engineering discipline (Mechanical, Electrical, Bio-Medical)
Years’ Experience Required: 8
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Responsibilities may include the following and other duties may be assigned. Develops modifies applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Devises and implements methods and procedures for inspecting testing and evaluating the precision and accuracy of products and production equipment. Designs or specifies inspection and testing mechanisms and equipment conducts quality assurance tests and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications. Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements. May specialize in the areas of design incoming material production control product evaluation and reliability inventory control and/or research and development as they apply to product or process quality.
SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies using specialized knowledge and skills normally acquired through advanced education.
DIFFERENTIATING FACTORS
Autonomy: Recognized expert managing large projects or processes . Exercises considerable latitude in determining deliverables of assignments with limited oversight from manager .
Organizational Impact: Contributes to defining the direction for new products processes standards or operational plans based on business strategy with a significant impact on work group results . May manage large projects or processes that span outside of immediate job area.
Innovation and Complexity: Problems and issues faced are difficult moderately complex and undefined and require detailed information gathering analysis and investigation . Develops solutions to moderately complex problems and/or makes moderate to significant improvements of processes systems or products independently to enhance performance of job area. Implements solutions to problems.
Communication and Influence: Represents organization as a primary contact for specific projects and initiatives communicates with internal and external customers and vendors at various levels . May negotiate with others to reach understanding or agreement and influence decisionmaking.
Leadership and Talent Management: Typically provides guidance coaching and training to other employees within job area. Typically manages major / moderately complex projects involving delegation of work and review of work products at times acting as a team leader.
Required Knowledge and Experience: Requires mastery of a specialty area and full knowledge of industry practices typically obtained through advanced education combined with experience. May have broad knowledge of project management. Requires a University Degree and minimum 7 years of relevant experience or advanced degree with a minimum of 5 years of relevant experience.
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