Medtronic
Principal Electrical Engineer, Tempe, AZ or Mounds View, MN
Medtronic, Mounds View, Minnesota, United States
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.
Interact with personnel on significant technical matters often requiring coordination between organizations.
Identify and oversee 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 (CIF’s).
Initiate change activity (CA) to modify and maintain design documentation (BOM’s, Specs, drawings).
Support CAPA’s (Corrective & Preventive Actions) and RPI’s (Released Product Investigations) including possible CAPA ownership.
Provide RPE input to new product development teams.
Assist Regulatory Specialists by providing design & clinical use data and rationale to support worldwide regulatory submissions and certification renewals.
Support IQ/OQ/PQ, DOE’s, SPC, Gauge R&R, Sampling methodologies, Data Analysis, Hypothesis Testing, Modeling/Predictive Analyses, Capability Studies (CpK) and Component Qualifications.
Collaborate with reliability and manufacturing personnel to determine and execute appropriate tests/assessments to evaluate supplier, process, material, design, or component changes prior to implementation.
Collaborate 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).
Assist manufacturing sites with lean layout initiatives, interfacility transfers and outsourcing.
Support cost reduction and continuous improvement projects.
Provide problem solving/trouble shooting support to manufacturing sites and key suppliers to increase yields, maintain process capability and improve efficiency and cost.
Support internal and external regulatory compliance audits.
Actively participate in new product development to RPE transfers; ensure 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).
Salary and Benefits Salary ranges for U.S. (excluding Puerto Rico) locations (USD): $134,400.00 – $201,600.00. 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. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).
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.
Simple Steps (global well‑being program).
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).
Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).
Equal Employment Opportunity 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.
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Interact with personnel on significant technical matters often requiring coordination between organizations.
Identify and oversee 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 (CIF’s).
Initiate change activity (CA) to modify and maintain design documentation (BOM’s, Specs, drawings).
Support CAPA’s (Corrective & Preventive Actions) and RPI’s (Released Product Investigations) including possible CAPA ownership.
Provide RPE input to new product development teams.
Assist Regulatory Specialists by providing design & clinical use data and rationale to support worldwide regulatory submissions and certification renewals.
Support IQ/OQ/PQ, DOE’s, SPC, Gauge R&R, Sampling methodologies, Data Analysis, Hypothesis Testing, Modeling/Predictive Analyses, Capability Studies (CpK) and Component Qualifications.
Collaborate with reliability and manufacturing personnel to determine and execute appropriate tests/assessments to evaluate supplier, process, material, design, or component changes prior to implementation.
Collaborate 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).
Assist manufacturing sites with lean layout initiatives, interfacility transfers and outsourcing.
Support cost reduction and continuous improvement projects.
Provide problem solving/trouble shooting support to manufacturing sites and key suppliers to increase yields, maintain process capability and improve efficiency and cost.
Support internal and external regulatory compliance audits.
Actively participate in new product development to RPE transfers; ensure 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).
Salary and Benefits Salary ranges for U.S. (excluding Puerto Rico) locations (USD): $134,400.00 – $201,600.00. 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. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).
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.
Simple Steps (global well‑being program).
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).
Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).
Equal Employment Opportunity 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.
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