Medtronic
Principal Electrical Engineer, Tempe, AZ or Mounds View, MN
Medtronic, Tempe, Arizona, us, 85285
We anticipate the application window for this opening will close on 18 Nov 2025.
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.
A Day in the Life
The Principal Hardware Engineer will be responsible for technical and mechanical design leadership for market-released implantable cardiac devices. This role involves collaboration with cross-functional partners such as reliability, regulatory, operations, and sourcing colleagues to evaluate and implement design changes. Represent the organization as the prime technical contact on contracts and projects. You will be required to work on-site at one of our regional site locations: California and Colorado/ Minnesota locations four (4) days per week. This on-site presence is crucial to fostering collaboration and maintaining a strong connection with our team and the workplace environment. Responsibilities
Interact with personnel on significant technical matters often requiring coordination between organizations Identifies and oversees testing required to obtain necessary data to support field actions, regulatory renewals, submissions and deficiency responses Provide critical evaluation of device design when representing design in review of Change Impact Forms (CIFs) Initiates change activity (CA) to modify maintain design documentation (BOMs, Specs, drawings) Supports CAPA’s (Corrective & Preventive Actions) and RPI’s (Released Product Investigations) including possible CAPA ownership Provides RPE input to new product development teams Assists Regulatory Specialists by providing design & clinical use data and rationale to support worldwide regulatory submissions and certification renewals. Supports IQ/OQ/PQ, DOE’s, SPC, Gauge R&R, Sampling methodologies, Data Analysis, Hypothesis Testing, Modeling/Predictive Analyses, Capability Studies (CpK) and Component Qualifications Collaborates with reliability and manufacturing personnel to determine and execute appropriate tests/assessments to evaluate supplier, process, material, design, or component changes prior to implementation Collaborates with reliability, manufacturing, materials, and R&D to investigate product performance issues/returned product analysis to identify root cause(s) and implement corrective action(s) Assists manufacturing sites with lean layout initiatives, interfacility transfers and outsourcing Supports cost reduction and continuous improvement projects Provides problem solving/trouble shooting support to manufacturing sites and key suppliers to increase yields, maintain process capability, and improve efficiency and cost Supports internal and external regulatory compliance audits Actively participates in new product development to RPE transfers; ensures completion of all transfer deliverables Key Job Responsibilities
Proficient knowledge of CRM devices (ICD’s, IPG’s, CRT-D/P, ICM) Working level understanding of CRM product implant procedures, clinical use conditions, new indications, competitive product landscape & state of the art industry status Proficient knowledge of medical device industry standards, regulations compliance requirements Basic knowledge of mechanical processes, materials, processes, PFMEA and DFMEA Demonstrates good judgment pertaining to issue escalation and consultation with other SME’s Able to work independently and exercise appropriate latitude when addressing abstract, yet to be defined technical issues and problems Results focused. Able to deliver consistent, high quality work to meet product performance, compliance, schedule, and budget requirements Able to provide solutions to a variety of technical problems of challenging scope and complexity Possesses working knowledge of statistical and data analysis tools. SPC, DOE, Gauge R&R, CpK Demonstrates clear, factual, and effective oral and written communication with variety of cross functional colleagues, technical peers, and senior-level management Able to facilitate cross functional group problem solving, decision making, and small projects; including CAPA’s Able to effectively prioritize and work on multiple assignments in parallel while keeping stakeholders updated Able to work independently, follow established procedures, and give/receive technical peer reviews of work deliverables for accuracy of technical content Minimum Requirements
Bachelor’s degree in Engineering, Business, or a related field. Minimum of 7 years of relevant experience OR Master's degree with a minimum of 5 years relevant experience OR PhD with 3 years relevant experience Nice to Have
Excellent time management skills with ability to manage multiple priorities and deliver on time Solid leadership and interpersonal skills including ability to effectively formulate and convey technical and cost/benefit/risk information with peers and senior leaders Strong verbal and written communication skills including ability to articulate complex ideas in easy to understand terms Working knowledge of Quality System Regulation (QSR 21 CFR 820), EU Medical Device Directive, and ISO (13485:2003) Knowledge of 6 Sigma (DFSS) principles Able to work well under pressure and maintain positive, engaged, and enthusiastic attitude Physical Job Requirements
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. (ADA-United States of America). About Medtronic
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be. We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future. Learn more about our business, mission, and our commitment to diversity here. Benefits & Compensation
Salary range (US excl. PR): $134,400.00 - $201,600.00. This position is eligible for a short-term incentive plan, which provides the opportunity to earn significant incentive compensation for achieving or exceeding your goals. Benefits for regular employees (20+ hrs/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. Benefits for 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; and Capital Accumulation Plan for VP and above. Temporary employees: eligible for paid sick time and Employee Stock Purchase Plan. Please note that the above benefits may not apply to workers in Puerto Rico. Equal Employment Opportunity Statement
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 here 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.
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The Principal Hardware Engineer will be responsible for technical and mechanical design leadership for market-released implantable cardiac devices. This role involves collaboration with cross-functional partners such as reliability, regulatory, operations, and sourcing colleagues to evaluate and implement design changes. Represent the organization as the prime technical contact on contracts and projects. You will be required to work on-site at one of our regional site locations: California and Colorado/ Minnesota locations four (4) days per week. This on-site presence is crucial to fostering collaboration and maintaining a strong connection with our team and the workplace environment. Responsibilities
Interact with personnel on significant technical matters often requiring coordination between organizations Identifies and oversees testing required to obtain necessary data to support field actions, regulatory renewals, submissions and deficiency responses Provide critical evaluation of device design when representing design in review of Change Impact Forms (CIFs) Initiates change activity (CA) to modify maintain design documentation (BOMs, Specs, drawings) Supports CAPA’s (Corrective & Preventive Actions) and RPI’s (Released Product Investigations) including possible CAPA ownership Provides RPE input to new product development teams Assists Regulatory Specialists by providing design & clinical use data and rationale to support worldwide regulatory submissions and certification renewals. Supports IQ/OQ/PQ, DOE’s, SPC, Gauge R&R, Sampling methodologies, Data Analysis, Hypothesis Testing, Modeling/Predictive Analyses, Capability Studies (CpK) and Component Qualifications Collaborates with reliability and manufacturing personnel to determine and execute appropriate tests/assessments to evaluate supplier, process, material, design, or component changes prior to implementation Collaborates with reliability, manufacturing, materials, and R&D to investigate product performance issues/returned product analysis to identify root cause(s) and implement corrective action(s) Assists manufacturing sites with lean layout initiatives, interfacility transfers and outsourcing Supports cost reduction and continuous improvement projects Provides problem solving/trouble shooting support to manufacturing sites and key suppliers to increase yields, maintain process capability, and improve efficiency and cost Supports internal and external regulatory compliance audits Actively participates in new product development to RPE transfers; ensures completion of all transfer deliverables Key Job Responsibilities
Proficient knowledge of CRM devices (ICD’s, IPG’s, CRT-D/P, ICM) Working level understanding of CRM product implant procedures, clinical use conditions, new indications, competitive product landscape & state of the art industry status Proficient knowledge of medical device industry standards, regulations compliance requirements Basic knowledge of mechanical processes, materials, processes, PFMEA and DFMEA Demonstrates good judgment pertaining to issue escalation and consultation with other SME’s Able to work independently and exercise appropriate latitude when addressing abstract, yet to be defined technical issues and problems Results focused. Able to deliver consistent, high quality work to meet product performance, compliance, schedule, and budget requirements Able to provide solutions to a variety of technical problems of challenging scope and complexity Possesses working knowledge of statistical and data analysis tools. SPC, DOE, Gauge R&R, CpK Demonstrates clear, factual, and effective oral and written communication with variety of cross functional colleagues, technical peers, and senior-level management Able to facilitate cross functional group problem solving, decision making, and small projects; including CAPA’s Able to effectively prioritize and work on multiple assignments in parallel while keeping stakeholders updated Able to work independently, follow established procedures, and give/receive technical peer reviews of work deliverables for accuracy of technical content Minimum Requirements
Bachelor’s degree in Engineering, Business, or a related field. Minimum of 7 years of relevant experience OR Master's degree with a minimum of 5 years relevant experience OR PhD with 3 years relevant experience Nice to Have
Excellent time management skills with ability to manage multiple priorities and deliver on time Solid leadership and interpersonal skills including ability to effectively formulate and convey technical and cost/benefit/risk information with peers and senior leaders Strong verbal and written communication skills including ability to articulate complex ideas in easy to understand terms Working knowledge of Quality System Regulation (QSR 21 CFR 820), EU Medical Device Directive, and ISO (13485:2003) Knowledge of 6 Sigma (DFSS) principles Able to work well under pressure and maintain positive, engaged, and enthusiastic attitude Physical Job Requirements
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. (ADA-United States of America). About Medtronic
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be. We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future. Learn more about our business, mission, and our commitment to diversity here. Benefits & Compensation
Salary range (US excl. PR): $134,400.00 - $201,600.00. This position is eligible for a short-term incentive plan, which provides the opportunity to earn significant incentive compensation for achieving or exceeding your goals. Benefits for regular employees (20+ hrs/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. Benefits for 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; and Capital Accumulation Plan for VP and above. Temporary employees: eligible for paid sick time and Employee Stock Purchase Plan. Please note that the above benefits may not apply to workers in Puerto Rico. Equal Employment Opportunity Statement
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 here 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.
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