Medtronic
Principal Mechanical Design Engineer for Medtronic (CRM RPE), Mounds View, MN
Medtronic, Mounds View, Minnesota, United States
Overview
Principal Electrical Engineer, Tempe, AZ or Mounds View, MN — Medtronic Join to apply for the Principal Electrical Engineer role at Medtronic. The position requires leadership in technical and mechanical design for market-released implantable cardiac devices and collaboration with cross-functional teams. Responsibilities
Provide technical and mechanical design leadership for market-released implantable cardiac devices. Collaborate with reliability, regulatory, operations, and sourcing colleagues to evaluate and implement design changes. Represent the organization as the primary technical contact on contracts and projects. Work on-site four days per week at one of the regional locations (California and Minnesota/Mounds View) to foster collaboration and engagement. Interact with personnel on significant technical matters across organizations. Identify and oversee testing to obtain data supporting field actions, regulatory renewals, submissions, and deficiency responses. Evaluate device design during Change Impact Form reviews and initiate change activity to maintain design documentation (BOMs, specifications, drawings). Support CAPA (Corrective & Preventive Actions) and RPI (Released Product Investigations), including possible CAPA ownership. Contribute input to new product development teams and assist Regulatory Specialists with design and clinical use data for worldwide submissions and renewals. Support IQ/OQ/PQ, DOE, SPC, Gauge R&R, sampling methodologies, data analysis, hypothesis testing, modeling/predictive analyses, CpK, and component qualifications. Collaborate with reliability, manufacturing, materials, and R&D to investigate product performance issues and implement corrective actions. Assist with lean layout initiatives, interfacility transfers, and outsourcing; support cost reduction and continuous improvement projects. Provide problem-solving and troubleshooting support to manufacturing sites and key suppliers to improve yields and efficiency; participate in internal and external regulatory audits. Actively participate in new product development and RPE transfers, ensuring completion of transfer deliverables. Qualifications
Bachelor’s degree in Engineering, Business, or a related field (minimum). Minimum of 7 years of relevant experience, or Master’s degree with at least 5 years of relevant experience, or PhD with 3 years of relevant experience. Proficient knowledge of CRM devices (ICDs, IPGs, CRT-D/P, ICM) and implant procedures, clinical use conditions, indications, and product landscape. Familiarity with medical device industry standards and regulatory requirements; basic knowledge of mechanical processes, PFMEA/DFMEA; statistical and data analysis tools (SPC, DOE, Gauge R&R, CpK). Strong communication skills for cross-functional collaboration; ability to prioritize and manage multiple assignments with stakeholders updated. Ability to work independently, escalate issues appropriately, and provide peer reviews of technical deliverables. Working knowledge of QSR 21 CFR 820, EU Medical Device Directive, and ISO 13485; familiarity with quality and process improvement concepts. Nice to Have
Excellent time management; leadership and interpersonal skills to convey technical and cost/risk information to peers and senior leaders. Strong verbal and written communication; ability to articulate complex ideas clearly. Experience with Lean/continuous improvement and CAPA processes; knowledge of DFSS principles. Ability to work under pressure with a positive, engaged attitude. Physical and Other Requirements
The physical demands reflect the essential functions of the job with reasonable accommodations available. For office roles, regular mobility, computer use, and communication with peers are expected. Regional site on-site requirements apply. EEO and Benefits
Medtronic is an equal employment opportunity employer. We offer a comprehensive benefits package and competitive compensation. See the job posting for details on benefits and eligibility.
#J-18808-Ljbffr
Principal Electrical Engineer, Tempe, AZ or Mounds View, MN — Medtronic Join to apply for the Principal Electrical Engineer role at Medtronic. The position requires leadership in technical and mechanical design for market-released implantable cardiac devices and collaboration with cross-functional teams. Responsibilities
Provide technical and mechanical design leadership for market-released implantable cardiac devices. Collaborate with reliability, regulatory, operations, and sourcing colleagues to evaluate and implement design changes. Represent the organization as the primary technical contact on contracts and projects. Work on-site four days per week at one of the regional locations (California and Minnesota/Mounds View) to foster collaboration and engagement. Interact with personnel on significant technical matters across organizations. Identify and oversee testing to obtain data supporting field actions, regulatory renewals, submissions, and deficiency responses. Evaluate device design during Change Impact Form reviews and initiate change activity to maintain design documentation (BOMs, specifications, drawings). Support CAPA (Corrective & Preventive Actions) and RPI (Released Product Investigations), including possible CAPA ownership. Contribute input to new product development teams and assist Regulatory Specialists with design and clinical use data for worldwide submissions and renewals. Support IQ/OQ/PQ, DOE, SPC, Gauge R&R, sampling methodologies, data analysis, hypothesis testing, modeling/predictive analyses, CpK, and component qualifications. Collaborate with reliability, manufacturing, materials, and R&D to investigate product performance issues and implement corrective actions. Assist with lean layout initiatives, interfacility transfers, and outsourcing; support cost reduction and continuous improvement projects. Provide problem-solving and troubleshooting support to manufacturing sites and key suppliers to improve yields and efficiency; participate in internal and external regulatory audits. Actively participate in new product development and RPE transfers, ensuring completion of transfer deliverables. Qualifications
Bachelor’s degree in Engineering, Business, or a related field (minimum). Minimum of 7 years of relevant experience, or Master’s degree with at least 5 years of relevant experience, or PhD with 3 years of relevant experience. Proficient knowledge of CRM devices (ICDs, IPGs, CRT-D/P, ICM) and implant procedures, clinical use conditions, indications, and product landscape. Familiarity with medical device industry standards and regulatory requirements; basic knowledge of mechanical processes, PFMEA/DFMEA; statistical and data analysis tools (SPC, DOE, Gauge R&R, CpK). Strong communication skills for cross-functional collaboration; ability to prioritize and manage multiple assignments with stakeholders updated. Ability to work independently, escalate issues appropriately, and provide peer reviews of technical deliverables. Working knowledge of QSR 21 CFR 820, EU Medical Device Directive, and ISO 13485; familiarity with quality and process improvement concepts. Nice to Have
Excellent time management; leadership and interpersonal skills to convey technical and cost/risk information to peers and senior leaders. Strong verbal and written communication; ability to articulate complex ideas clearly. Experience with Lean/continuous improvement and CAPA processes; knowledge of DFSS principles. Ability to work under pressure with a positive, engaged attitude. Physical and Other Requirements
The physical demands reflect the essential functions of the job with reasonable accommodations available. For office roles, regular mobility, computer use, and communication with peers are expected. Regional site on-site requirements apply. EEO and Benefits
Medtronic is an equal employment opportunity employer. We offer a comprehensive benefits package and competitive compensation. See the job posting for details on benefits and eligibility.
#J-18808-Ljbffr