Reliability Engineer II - Hardware / Electrical
About The Position
This is an exciting opportunity to support the continued scaling and improvement of Affera HW system in the Cardiac Ablation Solutions (CAS) Operating Unit as a Reliability Engineer. The Affera system is a primary portfolio driver for the CAS OU with integrated mapping, navigation, RF, and PF functionality. This Reliability role is on the Affera HW REL team with full lifecycle scope and a focus on released product engineering and quality response. Primary responsibilities will include Design Change, Design Verification, Risk Management, OEM/CM Supplier Change support, and risk response (Issue Evaluation/PHO/HRA/FCA). The role will report to the Sr. Manager for Affera Capital (HW) Reliability Engineering team.
Requirements
- Bachelor's degree and a minimum of 2 years of relevant experience OR Master’s degree with a minimum of 0 years of relevant experience
Nice To Haves
- Medical Device Experience
- Understanding and experience in design controls, V&V, and Risk Management - both commercial and development.
- System-thinking and process mapping, ability to effectively identify interfaces, dependencies, and control points.
- Demonstrated ability in stakeholder management and coordinating complex assignments with cross-functional teams
- Understanding of 21CFR820, ISO13485, and ISO14971
- Experience managing a QMS procedure/process
Responsibilities
- 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.
- Additional product Reliability responsibilities may be included, primarily focused on Affera Capital (HW) equipment DRM, change management, risk management, and risk response.
Benefits
- 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)
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Entry Level
