Katalyst CRO
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Manufacturing Engineer
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Katalyst CRO 4 months ago Be among the first 25 applicants Join to apply for the
Manufacturing Engineer
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Katalyst CRO Develop, optimize, and validate manufacturing processes using IQ, OQ, PQ, and DOE methodologies. Implement statistical process control (SPC) to monitor and improve process performance. Conduct process capability studies and identify Critical to Quality (CTQ) parameters. Ensure compliance with ISO 13485, 21 CFR 820, FDA regulations, and GMP standards. Support Quality Management Systems (QMS) and contribute to pFMEA and risk management activities. Create and revise Standard Operating Procedures (SOPs) and User Requirements Specifications (URS). Coordinate Engineering Change Requests (ECR), Engineering Change Orders (ECO), and Engineering Change Notices (ECN). Identify root causes of manufacturing issues and implement effective solutions. Apply lean manufacturing principles to improve efficiency and reduce waste. Utilize tools such as Minitab and Agile methodologies for data analysis and project tracking. Ensure compliance with clean room standards and best practices for medical device production.
Responsibilities
Develop, optimize, and validate manufacturing processes using IQ, OQ, PQ, and DOE methodologies. Implement statistical process control (SPC) to monitor and improve process performance. Conduct process capability studies and identify Critical to Quality (CTQ) parameters. Ensure compliance with ISO 13485, 21 CFR 820, FDA regulations, and GMP standards. Support Quality Management Systems (QMS) and contribute to pFMEA and risk management activities. Create and revise Standard Operating Procedures (SOPs) and User Requirements Specifications (URS). Coordinate Engineering Change Requests (ECR), Engineering Change Orders (ECO), and Engineering Change Notices (ECN). Identify root causes of manufacturing issues and implement effective solutions. Apply lean manufacturing principles to improve efficiency and reduce waste. Utilize tools such as Minitab and Agile methodologies for data analysis and project tracking. Ensure compliance with clean room standards and best practices for medical device production.
Requirements:
Bachelor's degree in engineering (Mechanical, Industrial, Manufacturing, or related field). 3+ years of experience in manufacturing engineering, preferably in the medical device industry. Proficient in process validation (IQ, OQ, PQ) and design of experiments (DOE). Strong knowledge of ISO 13485, 21 CFR 820, and GMP regulations. Experience with SPC, pFMEA, QMS, and clean room operations. Proficiency in tools like Minitab, Agile software, and other statistical analysis platforms. Excellent problem-solving and project management skills.
Required Skills:
Medical Device. Process Validation. Team Leadership. SPC (Statistical Process Control). ISO 13485. IQ, OQ, PQ, DOE. Regulatory Compliance. pFMEA. SOP. URS. QMS. Clean Rooms. CTQ. FDA. GMP. Processes Engineering Changes (ECR, ECO, ECN). Problem Solving. Agile. Minitab. 21 CFR 820. Project Management. Project Planning. Seniority level
Seniority level
Associate Employment type
Employment type
Contract Job function
Industries
Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x Get notified about new Manufacturing Engineer jobs in
North Haven, CT . Product Manufacturing Engineer - New Product Introduction (Onsite)
Manufacturing Engineer - New Product Introduction (Onsite)
Advanced Manufacturing (Mechanical) Engineer
Manufacturing Engineer - New Product Introduction (Onsite)
Deep River, CT $65,000.00-$73,000.00 1 week ago Northford, CT $98,400.00-$123,000.00 16 hours ago Meriden, CT $75,000.00-$95,000.00 3 weeks ago Newtown, CT $76,000.00-$120,000.00 1 day ago Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr
Manufacturing Engineer
role at
Katalyst CRO 4 months ago Be among the first 25 applicants Join to apply for the
Manufacturing Engineer
role at
Katalyst CRO Develop, optimize, and validate manufacturing processes using IQ, OQ, PQ, and DOE methodologies. Implement statistical process control (SPC) to monitor and improve process performance. Conduct process capability studies and identify Critical to Quality (CTQ) parameters. Ensure compliance with ISO 13485, 21 CFR 820, FDA regulations, and GMP standards. Support Quality Management Systems (QMS) and contribute to pFMEA and risk management activities. Create and revise Standard Operating Procedures (SOPs) and User Requirements Specifications (URS). Coordinate Engineering Change Requests (ECR), Engineering Change Orders (ECO), and Engineering Change Notices (ECN). Identify root causes of manufacturing issues and implement effective solutions. Apply lean manufacturing principles to improve efficiency and reduce waste. Utilize tools such as Minitab and Agile methodologies for data analysis and project tracking. Ensure compliance with clean room standards and best practices for medical device production.
Responsibilities
Develop, optimize, and validate manufacturing processes using IQ, OQ, PQ, and DOE methodologies. Implement statistical process control (SPC) to monitor and improve process performance. Conduct process capability studies and identify Critical to Quality (CTQ) parameters. Ensure compliance with ISO 13485, 21 CFR 820, FDA regulations, and GMP standards. Support Quality Management Systems (QMS) and contribute to pFMEA and risk management activities. Create and revise Standard Operating Procedures (SOPs) and User Requirements Specifications (URS). Coordinate Engineering Change Requests (ECR), Engineering Change Orders (ECO), and Engineering Change Notices (ECN). Identify root causes of manufacturing issues and implement effective solutions. Apply lean manufacturing principles to improve efficiency and reduce waste. Utilize tools such as Minitab and Agile methodologies for data analysis and project tracking. Ensure compliance with clean room standards and best practices for medical device production.
Requirements:
Bachelor's degree in engineering (Mechanical, Industrial, Manufacturing, or related field). 3+ years of experience in manufacturing engineering, preferably in the medical device industry. Proficient in process validation (IQ, OQ, PQ) and design of experiments (DOE). Strong knowledge of ISO 13485, 21 CFR 820, and GMP regulations. Experience with SPC, pFMEA, QMS, and clean room operations. Proficiency in tools like Minitab, Agile software, and other statistical analysis platforms. Excellent problem-solving and project management skills.
Required Skills:
Medical Device. Process Validation. Team Leadership. SPC (Statistical Process Control). ISO 13485. IQ, OQ, PQ, DOE. Regulatory Compliance. pFMEA. SOP. URS. QMS. Clean Rooms. CTQ. FDA. GMP. Processes Engineering Changes (ECR, ECO, ECN). Problem Solving. Agile. Minitab. 21 CFR 820. Project Management. Project Planning. Seniority level
Seniority level
Associate Employment type
Employment type
Contract Job function
Industries
Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x Get notified about new Manufacturing Engineer jobs in
North Haven, CT . Product Manufacturing Engineer - New Product Introduction (Onsite)
Manufacturing Engineer - New Product Introduction (Onsite)
Advanced Manufacturing (Mechanical) Engineer
Manufacturing Engineer - New Product Introduction (Onsite)
Deep River, CT $65,000.00-$73,000.00 1 week ago Northford, CT $98,400.00-$123,000.00 16 hours ago Meriden, CT $75,000.00-$95,000.00 3 weeks ago Newtown, CT $76,000.00-$120,000.00 1 day ago Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr