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1+ months

NPI Process Engineer

Kelly Services
Raynham, MA 02767
**_Kelly Engineering_** _Outsourcing & Consulting Group (KellyOCG), a managed solution provider and business unit of Kelly Services is currently seeking a_ **_NPI Process Engineer_** _for a long-term engagement at one of our Global clients in_ **_Raynham, MA_** _._


**_Remote 2 days a week and 3 onsite._**


_This role is a full-time,_ **_fully benefitted position._** _As a KellyOCG employee you will be eligible for_ **_50% paid Medical, Dental,_** _401K and a variety of other benefits to choose from. Youll also be eligible for paid time off, including holiday, vacation and sick/personal time. All KellyOCG employees receive annual performance reviews._


_As a_ **_Process Quality Engineer_** _placed with KellyOCG you will be responsible for the following:_


_Position Overview: The_ **_NPI Process Engineer_** _will actively support new product development as well as front end manufacturing technology and inspection technology feasibility studies. As part of this, this individual will work on small cross functional teams and lead/facilitate planning, conducting and directing engineering projects or studies, including complete projects requiring knowledge of a specialized field. They apply knowledge of engineering principles and practices within assignment areas._


_The_ **_NPI Process Engineer_** _will utilize Quality Engineering tools and practices for the effective and efficient development of_ **_products/processes throughout the product lifecycle_** _. The incumbent will also utilize_ **_Quality Engineering principles_** _and problem-solving skills to improve and maintain products/processes that are aligned with the overall Quality and Business vision. He/she will utilize appropriate risk management to prevent unanticipated failure modes and improve capability of processes. This person will support processes in early phases of development._


_Applies_ **_advanced Quality Engineering/Scientific Method techniques and principles_** _to daily tasks and activities. In addition, applies relevant regulations, standards, GxP requirements, and industry best practices to assignments._


**_Major Responsibilities & Duties:_**


_Business Improvements_


+ _Support quality improvement initiatives such as process and product characterizations that lead to cost improvements / cost avoidance._

+ _Review/analyze the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and/or other improvement tools and programs._

+ _Conduct benchmarking to develop more effective methods for improving quality_

+ _Supports the development of quality engineering and quality compliance with the right skill sets for new product introductions, and product life cycle management._


_Compliance/Regulatory_


+ _Review/analyze whether current product and processes (including actions or decisions conducted) are in compliance to standards such as the QSRs, ISO 13485, etc._

+ _Champions compliance to applicable Global Regulations and standards (e.g. QSRs, ISO, EN and Medical Device Directive (MD) requirements) including providing support during internal and external audits._


+ _Conduct periodic line audits to assess for production controls such as lot segregation. Review results of area audits to ensure that corrective and preventive actions are adequate._


_New Product/Process Introduction_


+ _Partners with R&D and other cross functional partners to ensure the proper application of design controls, risk management and the investigation/correction of design failures/challenges._

+ _Supports new product introduction as part of design transfer activities including early process concept development._

+ _Partners with J&J Global Supply chain, Finished Goods and material suppliers to ensure appropriate application of process validation, process control, and risk management; and the investigation/correction of process failures when needed._

+ _Develop measurement systems/capabilities, destructive tests, non-destructive tests for manufacturing processes_

+ _Develop Components of Variation (COV) studies and any applicable Design of Experiment (DoEs) as required for front end feasibility and process development_

+ _Explore relevant inspection and manufacturing technologies that meet needs of an NPD project_

+ _Develop control plans consistent with product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc._

+ _Develop, interpret and implement appropriate process monitoring and control methods consistent with the level of process/product risk._

+ _Collect data and execute/conduct various analytical/statistical analysis and interpretation as part of process improvements._

+ _Develop, interpret and implement standard and non-standard sampling plans_

+ _Assess effectiveness of measurement tools, destructive tests, non-destructive tests, measurement system analysis._

+ _Accountability and ownership for sampling plans of all types including acceptability of risk given the product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. including assessing, applying and interpreting acceptance sampling standard for manufacturing data._

+ _Assess and interpret common versus special cause variation in Manufacturing processing and determine adequacy of process limits._


_Product/Process Qualification_


+ _Develop appropriate IQ, OQ, PQ, TMV or Software Validation documentation as required._


_Risk Mitigation_


+ _Document, justify, review or analyze whether a proposed change to a process will not enhance the risk level in some way beyond capability of current controls or whether change will result in potential non-compliance to a required standard such as the QSRs._

+ _Assess the need for risk mitigation techniques given product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. Determine effectiveness of these techniques on previously implemented improvements._


_Strategic_


+ _Ensures effective quality strategies are created for the validation of test methods, process and design._


**_Qualifications_**


+ _A minimum of a_ **_Bachelors degree_** _, preferably in Engineering or related technical field._ **_Requires 4-6 years related experience_** _._

+ _Experience working in both an_ **_FDA and European regulatory environment_** _is preferred._

+ _This position will require relevant experience working in manufacturing/operations._

+ _In-depth knowledge of_ **_product/process Risk Management (FDA and ISO standards) is required._**

+ _Experience with a proven track record of implementing appropriate risk mitigation._

+ _Technical training and experience using_ **_Statistics, Lean and Six Sigma Methodologies is required including Measurement System Analysis, SPC, DOEs, Reliability_** _, etc._

+ _Strong knowledge_ **_of statistical software packages is preferred_** _with the ability to preview, graph and analyze data and be able to present data that facilitates/drives decision making._

+ **_The ability to perform "hands on" troubleshooting and problem solving is required._** _The ability to think on the feet and providing sound judgment is highly desired._

+ **_Good technical understanding of manufacturing equipment and processes is required_** _._

+ _Understanding of the_ **_NPI (New Product Introduction) process and Process Validation expertise is preferred._**

+ _A thorough understanding of GMP/ISO regulations and validation regulations is preferred._

+ _Advanced knowledge and proven leadership in the areas listed in the Duties and Responsibilities associated with the position._

+ _Demonstrated project management and project leadership abilities are required._


**_Important information:_** _This position is recruited for by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States immediately and without employer sponsorship._


_(_ **_F1 OPT/H1B_** _cannot be considered for this position)._


**Why Kelly** **** **?**


Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, were here every step of the way to find your dream engineering job.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.

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Posted: 2022-05-20 Expires: 2022-07-11

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NPI Process Engineer

Kelly Services
Raynham, MA 02767

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