Medtronic Plc
Principal Quality Engineer
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. In this exciting role as a Principal Quality Engineer, you will have responsibility for manufacturing validation, quality systems, and product quality for new product and process development, and manufacturing site transfer at the Rice Creek Pharma Operations Manufacturing site in Fridley, MN. The product portfolio includes new technologies and next-generation products in the combination drug/device product space. Manufacturing Central Platform employs the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe. The Manufacturing Central Platform offers devices and therapies to treat abnormal heart rhythms, as well as cardiac diagnostic and monitoring solutions. Rice Creek Pharma Operations, or Fridley, offers devices within defibrillation solutions, surgical infection control, and diabetes management portfolios. Act boldly. Compete to win. Move with speed and decisiveness. Foster belonging. Deliver resultsthe right way. That's the Medtronic Mindset
our cultural norms. Our brand is rooted in action, not just words. The Medtronic Mindset defines the expectations of our culture. Every person here plays a role in bringing it to life. We recognize your extraordinary potential to ensure future generations live better, healthier lives. Onsite At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We're working a minimum of 5 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. Responsibilities may include the following and other duties may be assigned. Develop, characterize, and validate medical device manufacturing processes. Provide guidance and knowledge on manufacturing process development and validation focusing on quality systems and combination product compliance. Collaborate with engineering and manufacturing functions to ensure the value stream complies with internal and/or external specifications, regulations, and standards such as ISO. Provide knowledge in quality assurance, specifically, cGMP, pharmaceutical manufacturing, API handling and controls, clean room environments, environmental controls and contamination. Review equipment, inspection, process validations, changes, etc., to ensure compliance and assess the impact on product reliability, process capability, and compliance status. Support activities required for combination product compliance and ensures activities are completed in parallel with development activities on time and budget. Employ First Time Quality mindset when developing manufacturing processes ensuring adequate controls are instilled in the process. Devise and implements methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment. Make use of appropriate quality tools, such as DOE, SPC, hypothesis testing, and capability studies; to measure, monitor, improve, and control the manufacturing line and select processes. Guide and contributes to failure analysis and issue resolution activities to ensure corrective/preventative action is accomplished. Ensure that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements. Must Have: Minimum Requirements Bachelor's Degree in Engineering, Science or technical field with 7+ years of work experience in Engineering and/or Quality OR Advanced Degree in Engineering, Science or technical field with 5+ years of work experience in Engineering and/or Quality Nice to Have Medical device, pharma, or drug-device combination products preferred. Experience with manufacturing execution systems. Experience with equipment and software validation. Strong written and verbal communication skills in English language. Comprehensive understanding of applicable Work Instructions, SOPs and ISO standards. Working knowledge of statistical methods associated with Six Sigma and quality control. Experience with site transfers of equipment and manufacturing processes. Ability to maintain a professional and respectful relationship with coworkers. Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. Medtronic offers a competitive Salary and flexible Benefits Package. A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Salary ranges for U.S (excl. PR) locations (USD): $119,200.00 - $178,800.00 This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others). The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program). The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums). Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico. Further details are available at the link below: Learn more about our business, mission, and our commitment to diversity. It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. If you are applying to perform work for Medtronic, Inc. ("Medtronic") in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. In this exciting role as a Principal Quality Engineer, you will have responsibility for manufacturing validation, quality systems, and product quality for new product and process development, and manufacturing site transfer at the Rice Creek Pharma Operations Manufacturing site in Fridley, MN. The product portfolio includes new technologies and next-generation products in the combination drug/device product space. Manufacturing Central Platform employs the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe. The Manufacturing Central Platform offers devices and therapies to treat abnormal heart rhythms, as well as cardiac diagnostic and monitoring solutions. Rice Creek Pharma Operations, or Fridley, offers devices within defibrillation solutions, surgical infection control, and diabetes management portfolios. Act boldly. Compete to win. Move with speed and decisiveness. Foster belonging. Deliver resultsthe right way. That's the Medtronic Mindset
our cultural norms. Our brand is rooted in action, not just words. The Medtronic Mindset defines the expectations of our culture. Every person here plays a role in bringing it to life. We recognize your extraordinary potential to ensure future generations live better, healthier lives. Onsite At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We're working a minimum of 5 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. Responsibilities may include the following and other duties may be assigned. Develop, characterize, and validate medical device manufacturing processes. Provide guidance and knowledge on manufacturing process development and validation focusing on quality systems and combination product compliance. Collaborate with engineering and manufacturing functions to ensure the value stream complies with internal and/or external specifications, regulations, and standards such as ISO. Provide knowledge in quality assurance, specifically, cGMP, pharmaceutical manufacturing, API handling and controls, clean room environments, environmental controls and contamination. Review equipment, inspection, process validations, changes, etc., to ensure compliance and assess the impact on product reliability, process capability, and compliance status. Support activities required for combination product compliance and ensures activities are completed in parallel with development activities on time and budget. Employ First Time Quality mindset when developing manufacturing processes ensuring adequate controls are instilled in the process. Devise and implements methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment. Make use of appropriate quality tools, such as DOE, SPC, hypothesis testing, and capability studies; to measure, monitor, improve, and control the manufacturing line and select processes. Guide and contributes to failure analysis and issue resolution activities to ensure corrective/preventative action is accomplished. Ensure that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements. Must Have: Minimum Requirements Bachelor's Degree in Engineering, Science or technical field with 7+ years of work experience in Engineering and/or Quality OR Advanced Degree in Engineering, Science or technical field with 5+ years of work experience in Engineering and/or Quality Nice to Have Medical device, pharma, or drug-device combination products preferred. Experience with manufacturing execution systems. Experience with equipment and software validation. Strong written and verbal communication skills in English language. Comprehensive understanding of applicable Work Instructions, SOPs and ISO standards. Working knowledge of statistical methods associated with Six Sigma and quality control. Experience with site transfers of equipment and manufacturing processes. Ability to maintain a professional and respectful relationship with coworkers. Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. Medtronic offers a competitive Salary and flexible Benefits Package. A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Salary ranges for U.S (excl. PR) locations (USD): $119,200.00 - $178,800.00 This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others). The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program). The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums). Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico. Further details are available at the link below: Learn more about our business, mission, and our commitment to diversity. It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. If you are applying to perform work for Medtronic, Inc. ("Medtronic") in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.