- Company Name
- Primary Talent Partners
- Job Title
- Reliability Software Engineer II
- Job Description
-
Job Title: Reliability Software Engineer II
Role Summary:
Lead reliability and safety engineering for new cardiac rhythm management devices, ensuring products meet regulations, customer expectations, and clinical safety. Serve as the subject‑matter expert on reliability, risk, and quality within R&D teams.
Expactations:
* 23‑month contract (potential extension), on‑site presence required three days per week.
* Collaborate with design, manufacturing, regulatory, clinical, and quality teams.
* Apply medical device standards, risk management processes, and statistical methods to safeguard product performance.
Key Responsibilities:
- Conduct risk severity and occurrence determinations and risk‑benefit analyses for cardiac medical products.
- Perform risk analysis studies for new designs and processes.
- Develop and maintain reliability/safety engineering programs to meet company, customer, and regulatory objectives.
- Support technical reliability/safety studies and evaluate engineering design concepts, including DOE and statistical process control.
- Recommend design or test modifications and robust design practices (DfR, DRM, DFSS, DFLS).
- Ensure corrective actions meet acceptable reliability/safety standards.
- Participate in design and risk reviews and provide expertise on ISO 14971, 21 CFR Part 820, ISO 13485.
- Document findings, proposals, and design changes for regulatory submissions.
Required Skills:
- Strong understanding of product reliability and safety engineering principles.
- Proficiency in quantitative risk assessment techniques (PHA, HA, FTA, DFMEA, DFSS, DFLS).
- Applied knowledge of statistical methods and DOE.
- Knowledge of CMMI, Six Sigma, and quality systems (ISO 13485, 21 CFR Part 820).
- Ability to work effectively in cross‑functional, multidisciplinary teams.
- Excellent written and verbal communication, documentation, and regulatory writing.
Required Education & Certifications:
- Bachelor's degree in engineering, applied science, or related field; minimum 2 years of relevant experience.
- CSRE (Certified Software Reliability Engineer) certification preferred.
- Advanced degree and/or certifications in medical device, risk management, or quality management are a plus.
Mounds view, United states
On site
Junior
03-10-2025