Katalyst CRO
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R&D Engineer (specialist)
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Katalyst CRO 8 months ago Be among the first 25 applicants Join to apply for the
R&D Engineer (specialist)
role at
Katalyst CRO Get AI-powered advice on this job and more exclusive features. Design and develop test methods to support additional studies. Apply engineering principles to product design analysis and assessment. Produce engineering reports to provide technical explanation to support domestic and international regulatory submissions. Leverage engineering knowledge in conducting complaint evaluations and CAPA investigations to understand potential device failures. Prepare technical product documentation including design history files, drawings, bills of materials, test protocols and reports, engineering change orders, etc. Coordinate and lead competitive testing and aging testing. Interact with physicians to assist with product demonstrations. Optimize and refine existing products. Develop familiarity with endovascular procedures and apply the knowledge to product development and product risk assessment. Provide guidance to technicians and pilot associates. Identify problems and recommend solutions.
Responsibilities
Design and develop test methods to support additional studies. Apply engineering principles to product design analysis and assessment. Produce engineering reports to provide technical explanation to support domestic and international regulatory submissions. Leverage engineering knowledge in conducting complaint evaluations and CAPA investigations to understand potential device failures. Prepare technical product documentation including design history files, drawings, bills of materials, test protocols and reports, engineering change orders, etc. Coordinate and lead competitive testing and aging testing. Interact with physicians to assist with product demonstrations. Optimize and refine existing products. Develop familiarity with endovascular procedures and apply the knowledge to product development and product risk assessment. Provide guidance to technicians and pilot associates. Identify problems and recommend solutions.
Requirements:
Master's degree in science, engineering, or a related field. PMP Certification preferred. Experience in leading process improvement methodologies (e.g., Lean, Hoshin or 6-sigma). Good understanding of the Quality System Regulations (ISO 9001, ISO 13485, 21 CFR Part 803, 806 & 820) and knowledge of medical device process requirements. 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 Sign in to set job alerts for “Research And Development Engineer” roles.
Minneapolis, MN $88,000.00-$130,000.00 11 hours ago Eden Prairie, MN $88,500.00-$132,600.00 4 weeks ago Bloomington, MN $95,000.00-$115,000.00 1 week ago Minneapolis, MN $75,000.00-$93,000.00 6 days ago Minneapolis–Saint Paul, WI $150,000.00-$160,000.00 1 week ago Plymouth, MN $88,000.00-$121,000.00 3 weeks ago St Paul, MN $85,000.00-$130,000.00 1 week ago Greater Minneapolis-St. Paul Area 3 months ago Associate Director - AI/Data Science Product EngineerProducts & EngineeringMinneapolis, MN
Minneapolis, MN $120,000.00-$185,000.00 4 weeks ago Maple Grove, MN $76,000.00-$144,400.00 1 month ago Lead Machine Learning / AI Engineer - Personalization (Python, PySpark, ML Ops)
Senior Software Engineer, Device Management - United States
Plymouth, MN $88,000.00-$110,000.00 3 weeks ago Blaine, MN $70,000.00-$75,000.00 1 month ago Eagan, MN $126,000.00-$269,600.00 1 day ago Greater Minneapolis-St. Paul Area $35.00-$45.00 6 days ago Plymouth, MN $127,700.00-$164,700.00 1 week ago Minneapolis, MN $100,000.00-$125,000.00 6 days ago Greater Minneapolis-St. Paul Area $65.00-$85.00 1 week ago New Product Development Quality Engineer
Project Engineer I - Various Midwest Locations
Minneapolis, MN $82,000.00-$110,700.00 4 weeks ago Minneapolis, MN $74,200.00-$92,800.00 5 days ago Minneapolis, MN $80,000.00-$115,000.00 1 day ago Software Development Engineer (Full Stack), Amazon Key
Minneapolis, MN $129,300.00-$223,600.00 2 days ago St Paul, MN $100,000.00-$125,000.00 6 days ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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R&D Engineer (specialist)
role at
Katalyst CRO 8 months ago Be among the first 25 applicants Join to apply for the
R&D Engineer (specialist)
role at
Katalyst CRO Get AI-powered advice on this job and more exclusive features. Design and develop test methods to support additional studies. Apply engineering principles to product design analysis and assessment. Produce engineering reports to provide technical explanation to support domestic and international regulatory submissions. Leverage engineering knowledge in conducting complaint evaluations and CAPA investigations to understand potential device failures. Prepare technical product documentation including design history files, drawings, bills of materials, test protocols and reports, engineering change orders, etc. Coordinate and lead competitive testing and aging testing. Interact with physicians to assist with product demonstrations. Optimize and refine existing products. Develop familiarity with endovascular procedures and apply the knowledge to product development and product risk assessment. Provide guidance to technicians and pilot associates. Identify problems and recommend solutions.
Responsibilities
Design and develop test methods to support additional studies. Apply engineering principles to product design analysis and assessment. Produce engineering reports to provide technical explanation to support domestic and international regulatory submissions. Leverage engineering knowledge in conducting complaint evaluations and CAPA investigations to understand potential device failures. Prepare technical product documentation including design history files, drawings, bills of materials, test protocols and reports, engineering change orders, etc. Coordinate and lead competitive testing and aging testing. Interact with physicians to assist with product demonstrations. Optimize and refine existing products. Develop familiarity with endovascular procedures and apply the knowledge to product development and product risk assessment. Provide guidance to technicians and pilot associates. Identify problems and recommend solutions.
Requirements:
Master's degree in science, engineering, or a related field. PMP Certification preferred. Experience in leading process improvement methodologies (e.g., Lean, Hoshin or 6-sigma). Good understanding of the Quality System Regulations (ISO 9001, ISO 13485, 21 CFR Part 803, 806 & 820) and knowledge of medical device process requirements. 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 Sign in to set job alerts for “Research And Development Engineer” roles.
Minneapolis, MN $88,000.00-$130,000.00 11 hours ago Eden Prairie, MN $88,500.00-$132,600.00 4 weeks ago Bloomington, MN $95,000.00-$115,000.00 1 week ago Minneapolis, MN $75,000.00-$93,000.00 6 days ago Minneapolis–Saint Paul, WI $150,000.00-$160,000.00 1 week ago Plymouth, MN $88,000.00-$121,000.00 3 weeks ago St Paul, MN $85,000.00-$130,000.00 1 week ago Greater Minneapolis-St. Paul Area 3 months ago Associate Director - AI/Data Science Product EngineerProducts & EngineeringMinneapolis, MN
Minneapolis, MN $120,000.00-$185,000.00 4 weeks ago Maple Grove, MN $76,000.00-$144,400.00 1 month ago Lead Machine Learning / AI Engineer - Personalization (Python, PySpark, ML Ops)
Senior Software Engineer, Device Management - United States
Plymouth, MN $88,000.00-$110,000.00 3 weeks ago Blaine, MN $70,000.00-$75,000.00 1 month ago Eagan, MN $126,000.00-$269,600.00 1 day ago Greater Minneapolis-St. Paul Area $35.00-$45.00 6 days ago Plymouth, MN $127,700.00-$164,700.00 1 week ago Minneapolis, MN $100,000.00-$125,000.00 6 days ago Greater Minneapolis-St. Paul Area $65.00-$85.00 1 week ago New Product Development Quality Engineer
Project Engineer I - Various Midwest Locations
Minneapolis, MN $82,000.00-$110,700.00 4 weeks ago Minneapolis, MN $74,200.00-$92,800.00 5 days ago Minneapolis, MN $80,000.00-$115,000.00 1 day ago Software Development Engineer (Full Stack), Amazon Key
Minneapolis, MN $129,300.00-$223,600.00 2 days ago St Paul, MN $100,000.00-$125,000.00 6 days ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr