Katalyst CRO
Sustaining Systems Design Quality Engineer
Katalyst CRO, Osseo, Minnesota, United States, 55311
Sustaining Systems Design Quality Engineer
Join to apply for the
Sustaining Systems Design Quality Engineer
role at
Katalyst CRO Sustaining Systems Design Quality Engineer
1 day ago Be among the first 25 applicants Join to apply for the
Sustaining Systems Design Quality Engineer
role at
Katalyst CRO Get AI-powered advice on this job and more exclusive features. Ownership of design change projects including scoping, assessment, and implementation. Develop, update, and maintain Design History File and Design Input / Output documentation. Update and maintain risk management files, such as the Hazard Analysis, Task Analysis, and Design FMEA. Develop and execute Design Verification, Design Validation, and Usability protocols and reports to meet or exceed internal and external requirements. Provide design quality support in the resolution of PIRs, CAPAs, and NCEPs. Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures. Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
Responsibilities
Ownership of design change projects including scoping, assessment, and implementation. Develop, update, and maintain Design History File and Design Input / Output documentation. Update and maintain risk management files, such as the Hazard Analysis, Task Analysis, and Design FMEA. Develop and execute Design Verification, Design Validation, and Usability protocols and reports to meet or exceed internal and external requirements. Provide design quality support in the resolution of PIRs, CAPAs, and NCEPs. Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures. Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
Requirements :
3-5 Years with BS. Degree must be clearly stated on resume. Bachelor's degree in mechanical, electrical, or biomedical engineering, highly preferred. Experience with design control, risk management, and medical device standards compliance. Experience with corrective and preventive action. Adaptable and effective collaborator in a team environment and in self-directed work. Strong communication skills. Seniority level
Seniority level
Associate Employment type
Employment type
Contract Job function
Job function
Quality Assurance Industries
Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x Get notified about new System Design Engineer jobs in
Maple Grove, MN . Ramsey, MN $75,000.00-$130,000.00 2 days ago Eden Prairie, MN $80,000.00-$85,000.00 2 weeks ago Brooklyn Park, MN $85,000.00-$105,000.00 1 day ago Greater Minneapolis-St. Paul Area 1 week ago Maple Grove, MN $79,000.00-$118,000.00 5 days ago Brooklyn Park, MN $105,000.00-$125,000.00 1 day ago Plymouth, MN $88,000.00-$114,000.00 3 days ago Minneapolis, MN $90,000.00-$120,000.00 1 month ago Minneapolis, MN $71,600.00-$113,700.00 9 months ago Brooklyn Park, MN $80,000.00-$97,000.00 2 weeks ago Medina, MN $68,888.14-$103,332.21 2 days ago Minneapolis, MN $70,000.00-$80,000.00 6 months ago Plymouth, MN $58,000.00-$90,000.00 2 months ago Maplewood, MN $80,000.00-$90,000.00 1 week ago St Paul, MN $100,000.00-$150,000.00 3 days ago Minneapolis, MN $80,000.00-$105,000.00 2 days ago Greater Minneapolis-St. Paul Area $99,000.00-$115,000.00 2 weeks ago Eden Prairie, MN $58,000.00-$90,000.00 1 month ago Mechanical Engineer/Design Engineer (Mechanical Contractor)
Eden Prairie, MN $90,000.00-$135,000.00 3 days ago Greater Minneapolis-St. Paul Area 2 weeks 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
Join to apply for the
Sustaining Systems Design Quality Engineer
role at
Katalyst CRO Sustaining Systems Design Quality Engineer
1 day ago Be among the first 25 applicants Join to apply for the
Sustaining Systems Design Quality Engineer
role at
Katalyst CRO Get AI-powered advice on this job and more exclusive features. Ownership of design change projects including scoping, assessment, and implementation. Develop, update, and maintain Design History File and Design Input / Output documentation. Update and maintain risk management files, such as the Hazard Analysis, Task Analysis, and Design FMEA. Develop and execute Design Verification, Design Validation, and Usability protocols and reports to meet or exceed internal and external requirements. Provide design quality support in the resolution of PIRs, CAPAs, and NCEPs. Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures. Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
Responsibilities
Ownership of design change projects including scoping, assessment, and implementation. Develop, update, and maintain Design History File and Design Input / Output documentation. Update and maintain risk management files, such as the Hazard Analysis, Task Analysis, and Design FMEA. Develop and execute Design Verification, Design Validation, and Usability protocols and reports to meet or exceed internal and external requirements. Provide design quality support in the resolution of PIRs, CAPAs, and NCEPs. Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures. Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
Requirements :
3-5 Years with BS. Degree must be clearly stated on resume. Bachelor's degree in mechanical, electrical, or biomedical engineering, highly preferred. Experience with design control, risk management, and medical device standards compliance. Experience with corrective and preventive action. Adaptable and effective collaborator in a team environment and in self-directed work. Strong communication skills. Seniority level
Seniority level
Associate Employment type
Employment type
Contract Job function
Job function
Quality Assurance Industries
Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x Get notified about new System Design Engineer jobs in
Maple Grove, MN . Ramsey, MN $75,000.00-$130,000.00 2 days ago Eden Prairie, MN $80,000.00-$85,000.00 2 weeks ago Brooklyn Park, MN $85,000.00-$105,000.00 1 day ago Greater Minneapolis-St. Paul Area 1 week ago Maple Grove, MN $79,000.00-$118,000.00 5 days ago Brooklyn Park, MN $105,000.00-$125,000.00 1 day ago Plymouth, MN $88,000.00-$114,000.00 3 days ago Minneapolis, MN $90,000.00-$120,000.00 1 month ago Minneapolis, MN $71,600.00-$113,700.00 9 months ago Brooklyn Park, MN $80,000.00-$97,000.00 2 weeks ago Medina, MN $68,888.14-$103,332.21 2 days ago Minneapolis, MN $70,000.00-$80,000.00 6 months ago Plymouth, MN $58,000.00-$90,000.00 2 months ago Maplewood, MN $80,000.00-$90,000.00 1 week ago St Paul, MN $100,000.00-$150,000.00 3 days ago Minneapolis, MN $80,000.00-$105,000.00 2 days ago Greater Minneapolis-St. Paul Area $99,000.00-$115,000.00 2 weeks ago Eden Prairie, MN $58,000.00-$90,000.00 1 month ago Mechanical Engineer/Design Engineer (Mechanical Contractor)
Eden Prairie, MN $90,000.00-$135,000.00 3 days ago Greater Minneapolis-St. Paul Area 2 weeks 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