Senior Process Engineer
Senior Process Engineer Elkton, MD Direct hire On-site The Sr Engineer I - Process Engineering position is responsible for providing advanced engineering support to existing product process transfer projects, process improvements/cost reduction activities affecting the form, fit, or function of the product, and new product development process and production equipment development requirements in accordance with all client processes and procedures.
Job Details
Provide engineering support to the design, development, and qualification of products, processes, and process equipment in accordance with TMC QA101 Product Development & Design Controls and in full compliance with all design control, quality, and company regulations and national and international regulatory body requirements.
This activity includes, but is not limited to, the understanding of change control, validation, documentation practices, process control, and design control requirements.
Participate in and provide manufacturability insight and guidance to the design and development of new products to facilitate the development of viable production processes for the products under development.
Serve as a Process Leader for the development or transfer of production processes.
Accountable for the execution of all engineering activities required to develop, implement, and validate processes under development or modification.
The Process Leader owns the big picture of the production process and ensures that its overall performance and validation requirements are achieved.
Actively lead and participate in the performance of formal process validations to ensure their compliance to validation protocols.
Ensure all protocols and validation reports are correct and well-written.
Install production/process equipment and support the conduct of Installation Qualification (IQ), Operational Qualification (OQ), pre-Process Qualification (PQ), and formal PQ validation activities and the documentation of their results.
As required, serve as a Problem Solver to product and process issues and apply the proper engineering tools and techniques for their resolution and implementation of any required process modifications.
Participate in and contribute to project team meetings, Design Reviews, and other formal project reviews.
Participate in and provide input to the development of project planning activities to include project cost and schedule estimates and performance requirements definition.
Prepare and present technical presentations to all levels of personnel in a manner that effectively communicates technical activities in an understandable way to the target audience.
Knowledge, Skills, Abilities
Experience in the development of new manufacturing processes for global Medical Devices or other highly regulated industries in accordance with global regulatory and quality standards and requirements.
Experience in the application of Design for Manufacturability (DFM); Design for Assembly (DFA), and Lean Six Sigma principles and tools.
Demonstrated understanding of the cross-functional interactions needed for the development of new products and manufacturing processes, preferably within FDA design control guidelines.
Demonstrated strong analytical and problem-solving skills; ability to solve complex problems and implement solutions or processes.
Demonstrated ability in the design, development, and implementation through production qualification of a new or novel medical device production process.
Strong communications skills.
Demonstrated ability to understand and explain complex engineering problems to non-engineering personnel; the ability to create and deliver presentations to executive management; and the ability to prepare detailed Technical Reports appropriate to send to the FDA.
Effective use of MS Office Suite.
Background/Experience
Bachelor's in Mechanical, Biomedical, or similar engineering discipline from an accredited university or college
PLUS 7 or more years of working experience with increasing responsibility in Product and Process Development in the medical device field.
Salary range $105,000 - $110,000 DOE About the client Client develops, manufactures, and markets a complete, solutions-based portfolio of high-quality medical devices used in a broad range of applications for numerous areas of the healthcare industry.
#TJP2022_SPEC Why Kelly (R) ? Your engineering skills are in demand, but how do you find the right fit? Easy.
With Kelly(R) 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, we're here every step of the way to find your dream engineering job.
About Kelly (R) At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential.
In fact, we're 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.
.
Estimated Salary: $20 to $28 per hour based on qualifications.
Job Details
Provide engineering support to the design, development, and qualification of products, processes, and process equipment in accordance with TMC QA101 Product Development & Design Controls and in full compliance with all design control, quality, and company regulations and national and international regulatory body requirements.
This activity includes, but is not limited to, the understanding of change control, validation, documentation practices, process control, and design control requirements.
Participate in and provide manufacturability insight and guidance to the design and development of new products to facilitate the development of viable production processes for the products under development.
Serve as a Process Leader for the development or transfer of production processes.
Accountable for the execution of all engineering activities required to develop, implement, and validate processes under development or modification.
The Process Leader owns the big picture of the production process and ensures that its overall performance and validation requirements are achieved.
Actively lead and participate in the performance of formal process validations to ensure their compliance to validation protocols.
Ensure all protocols and validation reports are correct and well-written.
Install production/process equipment and support the conduct of Installation Qualification (IQ), Operational Qualification (OQ), pre-Process Qualification (PQ), and formal PQ validation activities and the documentation of their results.
As required, serve as a Problem Solver to product and process issues and apply the proper engineering tools and techniques for their resolution and implementation of any required process modifications.
Participate in and contribute to project team meetings, Design Reviews, and other formal project reviews.
Participate in and provide input to the development of project planning activities to include project cost and schedule estimates and performance requirements definition.
Prepare and present technical presentations to all levels of personnel in a manner that effectively communicates technical activities in an understandable way to the target audience.
Knowledge, Skills, Abilities
Experience in the development of new manufacturing processes for global Medical Devices or other highly regulated industries in accordance with global regulatory and quality standards and requirements.
Experience in the application of Design for Manufacturability (DFM); Design for Assembly (DFA), and Lean Six Sigma principles and tools.
Demonstrated understanding of the cross-functional interactions needed for the development of new products and manufacturing processes, preferably within FDA design control guidelines.
Demonstrated strong analytical and problem-solving skills; ability to solve complex problems and implement solutions or processes.
Demonstrated ability in the design, development, and implementation through production qualification of a new or novel medical device production process.
Strong communications skills.
Demonstrated ability to understand and explain complex engineering problems to non-engineering personnel; the ability to create and deliver presentations to executive management; and the ability to prepare detailed Technical Reports appropriate to send to the FDA.
Effective use of MS Office Suite.
Background/Experience
Bachelor's in Mechanical, Biomedical, or similar engineering discipline from an accredited university or college
PLUS 7 or more years of working experience with increasing responsibility in Product and Process Development in the medical device field.
Salary range $105,000 - $110,000 DOE About the client Client develops, manufactures, and markets a complete, solutions-based portfolio of high-quality medical devices used in a broad range of applications for numerous areas of the healthcare industry.
#TJP2022_SPEC Why Kelly (R) ? Your engineering skills are in demand, but how do you find the right fit? Easy.
With Kelly(R) 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, we're here every step of the way to find your dream engineering job.
About Kelly (R) At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential.
In fact, we're 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.
.
Estimated Salary: $20 to $28 per hour based on qualifications.
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