Getinge
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With a passion for life
Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers. With a passion for life
Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers.
Are you looking for an inspiring career? You just found it.
Job Overview
Supports the Manufacturing Engineering department needs with an emphasis on Corrective Action and Preventive Action Process (CAPA).
The primary responsibilities of the Senior Manufacturing Engineer (CAPA Process) position are:
Lead and owns CAPAs in the areas of process and product improvements Investigation and response to production issues or to customer complaints Mentor lower level engineers Ensure compliance to procedures for CAPA Systems ,regulations of FDA, and other regulatory bodies Develop and maintain production documentation such as procedures, routers, BOMs.
Primary
Job Responsibilities and Essential Duties
Serves as a CAPA Owner Supports Manufacturing Engineering, which includes ensuring that corrective and preventive actions are issued as required, properly investigated, documented, effective, and completed on time. Identifies and leads implementation of new opportunities for improvements to work processes, production, and other areas as identified. Investigates product/component issues by conducting failure investigations, complaint trending, and Product Inquiries. Other CAPA related duties as assigned
Secondary
Responsible for the development/refinement of production processes and equipment; development and execution of process validations (Installation, Operational, & Process Qualifications) with sound engineering practices, and within company policy and regulations of FDA, and other regulatory bodies. The Senior Engineer utilizes a wide range of engineering principles, theories and concepts in the manufacturing/mechanical engineering discipline, plus a working knowledge of related disciplines to solve a wide range of difficult problems with imaginative and practical approaches. Provides training and guidance to lower level Manufacturing Engineering personnel. Guidance may be technical or project related as Project Leader or Lead Engineer of small to medium projects Support efforts for complaint investigation compliance with the Food and Drug Administration (FDA), European Union Medical Device Directive (MDD), European Union Medical Device Reporting (EUMDR), Alternate Summary Report (ASR), and applicable regulations and regulatory governing standards. Ensure timely and accurate investigations of returned products to support effective complaint closures as required by Complaint Engineering group. Supports the FDA and other 3rd party audits Lead and execute design changes applicable to Manufacturing Engineering needs Assess and Implement solutions relating to Corrective and Preventative Actions, Out of Tolerance Calibrations, and Non-conformances.
Minimum Requirements
Bachelor of Science degree in an engineering discipline (Industrial, Mechanical, or Biomedical Engineering preferred) with 5 years of experience in a regulated manufacturing environment and CAPA experience.
Required Knowledge, Skills And Abilities
Strong technical and analytical ability. Effective verbal and written communication skills and interpersonal skills. Team player. Experience with root cause analysis tools and techniques, project management, process development & process validations Demonstrated ingenuity and creativity. Proficiency with Microsoft Office applications. Working knowledge of statistical analysis., and DOE (Design of Experiments). General knowledge of Lean Manufacturing and Six Sigma principles. General understanding of GMPs (Good Manufacturing Practices) and FDA regulations
Salary range: $110-$135K Annually / 10% Bonus (depending on overall company performance)
About Us
With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.
Benefits At Getinge
At Getinge, we offer a comprehensive benefits package, which includes:
Health, Dental, and Vision insurance benefits 401k plan with company match Paid Time Off Wellness initiative & Health Assistance Resources Life Insurance Short and Long Term Disability Benefits Health and Dependent Care Flexible Spending Accounts Commuter Benefits Parental and Caregiver Leave Tuition Reimbursement
Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law. Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.
Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Engineering and Information Technology Industries Medical Equipment Manufacturing, Biotechnology Research, and Hospitals and Health Care Referrals increase your chances of interviewing at Getinge by 2x Sign in to set job alerts for “Senior Engineer” roles.
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#J-18808-Ljbffr
Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers. With a passion for life
Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers.
Are you looking for an inspiring career? You just found it.
Job Overview
Supports the Manufacturing Engineering department needs with an emphasis on Corrective Action and Preventive Action Process (CAPA).
The primary responsibilities of the Senior Manufacturing Engineer (CAPA Process) position are:
Lead and owns CAPAs in the areas of process and product improvements Investigation and response to production issues or to customer complaints Mentor lower level engineers Ensure compliance to procedures for CAPA Systems ,regulations of FDA, and other regulatory bodies Develop and maintain production documentation such as procedures, routers, BOMs.
Primary
Job Responsibilities and Essential Duties
Serves as a CAPA Owner Supports Manufacturing Engineering, which includes ensuring that corrective and preventive actions are issued as required, properly investigated, documented, effective, and completed on time. Identifies and leads implementation of new opportunities for improvements to work processes, production, and other areas as identified. Investigates product/component issues by conducting failure investigations, complaint trending, and Product Inquiries. Other CAPA related duties as assigned
Secondary
Responsible for the development/refinement of production processes and equipment; development and execution of process validations (Installation, Operational, & Process Qualifications) with sound engineering practices, and within company policy and regulations of FDA, and other regulatory bodies. The Senior Engineer utilizes a wide range of engineering principles, theories and concepts in the manufacturing/mechanical engineering discipline, plus a working knowledge of related disciplines to solve a wide range of difficult problems with imaginative and practical approaches. Provides training and guidance to lower level Manufacturing Engineering personnel. Guidance may be technical or project related as Project Leader or Lead Engineer of small to medium projects Support efforts for complaint investigation compliance with the Food and Drug Administration (FDA), European Union Medical Device Directive (MDD), European Union Medical Device Reporting (EUMDR), Alternate Summary Report (ASR), and applicable regulations and regulatory governing standards. Ensure timely and accurate investigations of returned products to support effective complaint closures as required by Complaint Engineering group. Supports the FDA and other 3rd party audits Lead and execute design changes applicable to Manufacturing Engineering needs Assess and Implement solutions relating to Corrective and Preventative Actions, Out of Tolerance Calibrations, and Non-conformances.
Minimum Requirements
Bachelor of Science degree in an engineering discipline (Industrial, Mechanical, or Biomedical Engineering preferred) with 5 years of experience in a regulated manufacturing environment and CAPA experience.
Required Knowledge, Skills And Abilities
Strong technical and analytical ability. Effective verbal and written communication skills and interpersonal skills. Team player. Experience with root cause analysis tools and techniques, project management, process development & process validations Demonstrated ingenuity and creativity. Proficiency with Microsoft Office applications. Working knowledge of statistical analysis., and DOE (Design of Experiments). General knowledge of Lean Manufacturing and Six Sigma principles. General understanding of GMPs (Good Manufacturing Practices) and FDA regulations
Salary range: $110-$135K Annually / 10% Bonus (depending on overall company performance)
About Us
With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.
Benefits At Getinge
At Getinge, we offer a comprehensive benefits package, which includes:
Health, Dental, and Vision insurance benefits 401k plan with company match Paid Time Off Wellness initiative & Health Assistance Resources Life Insurance Short and Long Term Disability Benefits Health and Dependent Care Flexible Spending Accounts Commuter Benefits Parental and Caregiver Leave Tuition Reimbursement
Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law. Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.
Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Engineering and Information Technology Industries Medical Equipment Manufacturing, Biotechnology Research, and Hospitals and Health Care Referrals increase your chances of interviewing at Getinge by 2x Sign in to set job alerts for “Senior Engineer” roles.
New York, NY $200,000.00-$235,000.00 6 days ago New York, NY $175,000.00-$250,000.00 1 month ago Engineering Manager, Asset Personalization Experience
New York, NY $190,000.00-$920,000.00 1 week ago New York, NY $149,000.00-$201,000.00 5 months ago Senior Manager, Advanced Manufacturing Engineering
New York, NY $168,000.00-$211,000.00 2 weeks ago Principal Mechanical Engineer (Must Have Medical Device exp.)
Project Officer II - School Construction
New York, NY $88,200.00-$188,760.00 5 days ago Mission Critical Lead Mechanical Engineer
New York, NY $150,000.00-$220,000.00 1 week ago New York, NY $164,160.00-$237,500.00 2 weeks ago New York, NY $200,000.00-$250,000.00 6 days ago New York City Metropolitan Area $175,000.00-$225,000.00 18 hours ago New York, NY $160,000.00-$200,000.00 6 days ago Senior Mechanical Engineer (Implant Hardware)
Manhattan, NY $150,000.00-$170,000.00 1 month ago New York, NY $185,000.00-$215,000.00 5 days ago Senior Concrete Engineer, Kiewit Infrastructure Engineer
Senior Electrical Engineer- Project Manager
New York, NY $104,479.00-$156,718.00 2 weeks ago Vice President, Senior Software Engineer - Capital Markets
New York, NY $170,000.00-$200,000.00 2 weeks ago New York, NY $140,000.00-$170,000.00 1 month ago New York, NY $175,000.00-$250,000.00 6 days ago Senior Mechanical Engineer Project Manager (New York)
New York, NY $180,000.00-$200,000.00 1 month ago Engineering Manager, Search Quality & Ranking
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New York, NY $225,000.00-$450,000.00 5 days ago Senior Manager, Advanced Manufacturing Engineering
New York, NY $168,000.00-$211,000.00 2 weeks ago New York City Metropolitan Area $200,000.00-$225,000.00 3 weeks ago Emergency Communications Senior Engineer
New York, NY $150,000.00-$210,000.00 2 weeks ago New York, NY $130,000.00-$200,000.00 6 days ago Software Engineering Manager, Go-to-Market Operations
New York, NY $197,000.00-$291,000.00 1 week ago New York, NY $230,000.00-$250,000.00 5 months ago New York, NY $195,000.00-$235,000.00 6 days ago New York, NY $175,000.00-$210,000.00 6 days ago New York, NY $240,000.00-$264,000.00 2 weeks 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