Senior Reliability Engineer – Hardware, Electrical

Jobtailor; Massachusetts; On-site; USD 90,000 - 130,000; Full time

Job summary

Jobtailor in the United States (Massachusetts) seeks a Reliability Engineer to conduct reliability studies and DOE constructs for engineering designs. The role coordinates design controls, V&V, and risk management for both development and commercial activities.

Responsibilities include risk analysis, process control statistics, and proposing design changes to improve system reliability, with involvement in environmental testing and regulatory considerations.

Qualifications

• Bachelor's degree with 4+ years' relevant experience, or Master's with 2+ years, or PhD with 0 years.
• Experience with design controls, V&V, and risk management for medical devices.
• Systems thinking and process mapping to identify interfaces and control points.
• Stakeholder management and coordinating cross-functional teams.
• Knowledge of 21 CFR 820, ISO 13485, ISO 14971; electrical/electronic experience.

Responsibilities

• Develops reliability studies and DOE constructs for engineering designs.
• Recommends design/test methods and SPC procedures for reliability.
• Completes risk analysis studies for new designs and processes.
• Analyzes performance reports and control statistics; investigates variables.
• Ensures corrective measures meet reliability standards.
• Develops reliability programs to meet objectives.
• Develops mathematical models to identify high-risk units or processes.
• Proposes design or formulation changes to improve reliability.
• Determines samples for environmental testing to obtain valid data.
• Focus on Affera Capital (HW) DRM, change and risk management and response.

Skills

Reliability studies

Design of Experiments

V&V

Risk management

Stakeholder management

Cross-functional teams

Systems thinking

21CFR820

ISO13485

ISO14971

Electrical experience

Education

Bachelor's degree

Master's degree

PhD

Job description

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.

Requirements

• Bachelor's degree and a minimum of 4 years of relevant experience OR Master's degree with a minimum of 2 years of relevant experience OR PhD with 0 years relevant experience.
• Thorough 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 medical device experience.
• Electrical / electronic experience.