Technical Program Manager Jobs in Monticello, MN

Description

About us: 

For over three decades, Cirtec Medical has been a leading outsourcing partner for complex medical devices. We specialize in providing comprehensive solutions for Class II and III devices, from design and development to precision components and finished device assembly. Our expertise spans neuromodulation, implantable drug delivery, cardiac rhythm management, structural heart, mechanical circulatory support, and minimally invasive surgical systems.

Position Summary:   

The Principal Electrical Engineer – Active Implantable Medical Devices (AIMDs) is the technical leader responsible for the architecture, design, development, and verification of Class III implantable medical devices, including Implantable Pulse Generators (IPGs), neurostimulation systems, and other battery-powered implantable platforms.

This position provides technical leadership for multidisciplinary development teams and is responsible for creating safe, reliable, manufacturable, and regulatory-compliant electronic systems that meet performance, longevity, and patient safety requirements. The role requires expertise in implantable electronics, ultra-low-power design, rechargeable battery systems, wireless communications, risk management, and design controls within highly regulated medical device environments.

 Key Responsibilities: 

Technical & Program Leadership

• Lead the electrical architecture, design, and development of Class III implantable medical devices and associated external systems.
• Serve as the technical authority for implantable electronics development programs from concept through commercialization.
• Lead subsystem architecture trade studies involving power consumption, battery longevity, telemetry performance, patient safety, and manufacturability.
• Mentor and provide technical guidance to senior and junior electrical engineers, firmware engineers, and engineering technicians.
• Lead technical reviews with customers, clinical advisors, and cross-functional stakeholders.
• Lead technical interactions with customers and development partners.
• Direct internal and external engineering resources to achieve project objectives.
• Assist Program Managers with project planning, risk management, and technical execution.
• Document technical decisions, design changes, and engineering rationale throughout the development lifecycle.

Implantable Electronics Design

• Design and analyze implantable electronic systems to achieve performance, safety, reliability, and product longevity requirements.
• Design ultra-low-power analog and digital circuits for implantable applications.
• Develop stimulation output circuitry, sensing front ends, signal conditioning circuits, and implantable telemetry systems.
• Design rechargeable and primary battery-powered implantable systems.
• Develop battery management systems, charging circuits, inductive power transfer systems, and wireless charging architectures.
• Design power supplies, voltage regulation, monitoring circuits, and power-management architectures optimized for multi-year implant longevity.
• Conduct worst-case, tolerance, reliability, and lifetime analyses for implantable electronics.

Implant Communication & Telemetry

• Design and evaluate wireless communication systems including Bluetooth Low Energy (BLE), MICS band communications, Proprietary RF telemetry, NFC communications, Inductive coupling systems.
• Develop communication architectures between implantable devices and external programmers, chargers, or mobile applications.

Implant Safety & Risk Management

• Lead electronic system hazard analysis and risk-control implementation.
• Develop and document risk mitigations in accordance with ISO 14971, IEC 60601-1, IEC 60601-1-2, IEC 62304, IEC 81001-5-1, FDA Quality System Regulations.
• Participate in FMEA, Fault Tree Analysis, Safety Analysis, and Cybersecurity Risk Assessments.
• Implement hardware and firmware design controls to ensure patient safety and device reliability.

Printed Circuit Assembly Development

• Lead the design and review of high-density implantable printed circuit assemblies.
• Develop design rules and processes for schematic capture, layout, review, and release.
• Collaborate with mechanical engineers on miniaturized implantable packaging and hermetically sealed electronics assemblies.
• Support PCB technologies including HDI, Rigid-flex, Microvia, Ceramic substrates, Implantable interconnect technologies.

Systems Engineering & Requirements Development

• Develop and maintain system, subsystem, and hardware requirements.
• Participate in system architecture development and requirements decomposition.
• Lead requirements management, traceability, and configuration management activities.
• Collaborate with Systems Engineering to establish verification strategies and design inputs.

Verification & Validation

• Develop hardware verification plans, protocols, and reports.
• Lead electronic subsystem verification testing including Electrical performance, Environmental testing, EMC/EMI testing, Battery testing, Reliability testing, Accelerated life testing, Biocompatibility support activities.
• Support design validation, design transfer, and regulatory submissions.

Firmware and Embedded Systems

• Define firmware requirements and interfaces supporting implantable electronics.
• Support embedded software and firmware development related to Power management, Battery charging, Telemetry, Stimulation delivery, Diagnostics, Safety monitoring.
• Participate in cybersecurity architecture reviews for connected medical devices.

Manufacturing/Supplier Management

• Interface with suppliers and manufacturing partners supporting implantable electronics.
• Support component selection and qualification for long-life implantable applications.
• Create and release engineering documentation including: BOMs, Manufacturing instructions, Design specifications, Verification reports, DDF documentation.
• Support process qualification, supplier audits, and build transfers.

Quality & Compliance

• Ensure compliance with company quality systems and applicable regulatory standards.
• Support internal audits, external audits, FDA inspections, and notified-body reviews.
• Maintain accurate engineering documentation and design records.

Must Have: 

• Bachelor’s degree in Electrical Engineering or related field (STEM required). Master's Degree in Electrical Engineering, Biomedical Engineering, or related discipline preferred.
• 12+ years of relevant industry experience specifically in medical device R&D, significant in implantable or active medical devices.
• 5+ years of developing Class III implantable medical devices highly preferred.
• Demonstrated experience leading electrical architecture for Implantable Pulse Generators (IPGs), neurostimulators, pacemakers, defibrillators, cochlear implants, drug delivery systems, or similar active implantable devices.
• Strong experience with low-power electronics, battery-powered systems, and ultra-low leakage design.
• Proficiency in schematic capture and PCD design tools. 
• Experience bringing complex hardware from concept through design verification.
• Deep understanding of design controls, risk management, and regulated development processes.
• Strong analytical, troubleshooting, and route-cause analysis skills.
• Clear technical communication and documentation skills.

Good to have: 

• Experience with implantable device applications such as neurostimulation, cardiac rhythm management, drug delivery, or implantable sensors, deep brain stimulations systems (DBS), spinal cord stimulation systems (SCS), ASIC development and integration, and battery longevity modeling.
• Working familiarity with designing stimulation, sensing, or bio-potential front-end circuits.
• Knowledge of EMI/EMC, ESD, and signal integrity in implantable or medical environments.
• Experience with hermetic packaging, feedthroughs, and implantable interconnects.
• Familiarity with wireless or telemetry systems used in implantable devices
• Ability to support manufacturing transfers and sustaining engineering.
• Previous experience contributing to FDA submissions and technical sections of regulatory filings.

Salary Range: Competitive salary range between $125,000-$180,000 based on qualifications and relevant experience.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

We work to create a culture that is built on innovation, respect, transparency and communication, and hope you take pride in being a member of our team. It is Cirtec’s goal to create a great work environment and to keep the company a great place to work. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Our benefits include Training and career development, Healthcare and well-being programs including medical, dental, vision, wellness and occupational health programs, Paid Time Off and 401(k) retirement savings with a company match.