Reliability Engineer

Sr. Reliability Engineer (24 month contract // Mounds View, MN):

Alternative Title: Sr. Software Safety Engineer

Top Skills:

1. Experience with Verification and Validation (V&V) Testing
2. Experience with Risk Management for Software (ISO 14971, PHA, HA, FTA, DFMEA)
3. Experience in a regulated industry

Education: Must have a Bachelor’s degree in Engineering

Target Years of Experience: Must have 4 years of experience, but preferring candidates with 6-10 years of experience

Description:

This position offers an exciting opportunity to drive software reliability and safety engineering within dynamic new product development teams for R&D. The candidate will be a pivotal member of cross-functional teams, serving as the go-to expert for reliability, safety, and quality functions. As a core member of the R&D project teams, the Sr. Software Safety Engineer will drive excellence in quality and reliability programs. This dynamic role involves leading Design for Reliability (DfR) initiatives, offering technical expertise, actively participating in design and risk reviews, and shaping the development of cutting-edge technologies. Collaborating with multidisciplinary teams, the position is pivotal in ensuring that innovative solutions meet the highest safety and reliability standards, fostering impactful advancements in patient care

Duties:

• 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/safety engineering programs to achieve company, customer, and governmental agency reliability/safety objectives.
• Develops, coordinates, and conducts technical reliability/safety 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 and safety.
• Proposes changes in design or formulation to improve system and/or process reliability and product safety.

Required Skills:

• Bachelor’s degree with 2 years of work experience in engineering and/or quality
• Experience in the application of Risk Management (ISO 14971) and hazard analysis and risk analysis techniques (e.g., PHA, HA, FTA, DFMEA).
• Strong understanding of and experience in the application of statistics, including experience with Minitab.
• Experience in TMV, DFMEA, PFMEA, CAPA, Process controls, and design controls.

Qualified to assess patient safety risks via one of the following:

• Medical doctor with related device experience
• Engineer who has achieved IBHRE or NASPE Exam certification
• Personnel with at least 5 years of clinical field experience in the past 15 years. The relevant field experience could include the following:
• Nurse
• Field Personnel such as: Clinical Specialist, Technical Field Educator, Field
• Clinical Engineer
• Technical Services (cardiac products)
• Personnel with 3-5 years of previous clinical experience related to cardiac therapy products.

Preferred Skills:

• Advanced degree in engineering or science.
• Proven understanding of product reliability/safety engineering principles.
• Experience in a highly regulated industry, preferably implantable medical devices.
• Experience with 21 CFR Part 820 (Quality System Regulation), ISO 13485, etc.
• Ability to independently lead investigations to identify system/product failures, hazards, hazardous situations, and harms.
• Certified Software Reliability Engineer (CSRE) certified.
• Exposure to or experience working in or with design, quality, regulatory, clinical and/or manufacturing.
• Experience in the design, maintenance, or continuation engineering of released software or software systems, including mobile applications.
• Knowledge of Design for Reliability (DfR), Design for Reliability and Manufacturability (DRM), Design for Six Sigma (DFSS), Design for Lean Sigma (DFLS), and/or robust design practices.