Principal product performance engineer
21000n0c
Mounds view, mn preferred or remote within the united states
Careers that change lives
In this role as a principal product performance engineer, you will have responsibility to monitor field performance of cardiac ablation solutions (cas) therapies, diagnostics, devices and systems throughout the post-market phase of the productYou will ensure early identification, escalation and risk assessments of emerging quality signals.
Cardiac ablation solutions
Cardiac ablation solutions offers cardiac mapping and ablation solutions for arrhythmia management.
A day in the life
Maintain post-market surveillance plans and complete periodic safety update reports (psur) for assigned product areas.
Compile and analyze product performance reports.
Analyze potential quality issues impacting field productDrive cross-functional alignment to determine need for product hold order (pho), field corrective action (fca) or customer communicationsAssessments follow health hazard analysis (hha)/health risk assessment (hra) or issue impact assessments (iia) processes.
Support pho and fca teamsAssess and document corrections and removals as defined by fda 21 cfr part 806.
Resolve inquiries regarding product performance from physician customers and external regulatory agencies.
Ensure product risk management files reflect current field performance for released products.
In addition to supporting released products, may provide risk management support for new product acquisitions and products under clinical evaluation.
Responsibilities may also include the following and other duties may be assigned.
Develops, coordinates and conducts technical reliability studies and evaluations of engineering design concepts and design of experiments (doe) constructs.
Recommends design or test methods and statistical process control procedures for achieving required levels of product reliability.
Completes risk analysis studies of new design and processes.
Compiles and analyzes performance reports and process control statistics; investigates and analyzes relevant variables potentially affecting product and processes.
Ensures that corrective measures meet acceptable reliability standards.
Analyzes preliminary plans and develops reliability engineering programs to achieve company, customer and governmental agency reliability objectives.
May develop mathematical models to identify units, batches or processes posing excessive failure risks.
As necessary, proposes changes in design or formulation to improve system and/or process reliability.
May determine units and/or batches requiring environmental testing, and specifies minimum number of samples to obtain statistically valid data.
Must have: minimum requirements
To be considered for this role, please ensure the minimum requirements are evident on your resume.
Bachelors degree in engineering, science or technical field with 7+ years of experience in quality and/or engineering or advanced degree in engineering, science or technical field with 5+ years of experience in quality and/or engineering
Nice to have
Advanced degree in science, engineering or another technical field
Medical doctor with related device experience
Engineer who has achieved ibhre exam certification
Personnel with at least 5 years of clinical field experienceExamples include: nurse, clinical specialist, technical field educator, field clinical engineer, technical services
Reliability experience with safety engineering, reliability engineering, biomedical engineering or product development engineering experience.
Experience in a highly-regulated industry, preferably implantable medical devices.
Knowledge of cardiac anatomy, physiology and primary disease states.
Experience with 21 cfr part 820, iso 13485, iso 14971, hazard analysis and risk analysis techniques (e.g., fta, dfmea, risk management report & files).
About medtronic
Together, we can change healthcare worldwideAt medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend lifeWe challenge ourselves and each other to make tomorrow better than yesterdayIt 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 teamLet’s work together to address universal healthcare needs and improve patients’ livesHelp us shape the future.
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 jobReasonable accommodations may be made to enable individuals with disabilities to perform the essential functionsFor office roles: while performing the duties of this job, the employee is regularly required to be independently mobileThe employee is also required to interact with a computer, and communicate with peers and co-workersContact 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)
Travel less than 10%
