Planet Pharma
Base pay range
$60.00/hr – $85.00/hr (23‑month contract, pay depends on experience) In this exciting role as a Sr. Software Safety Engineer, you will have responsibility for ensuring our products exceed the safety and reliability requirements and expectations of patients, clinicians, regulators, and the business. This position offers an exciting opportunity to drive software reliability and safety engineering within dynamic new product development teams for R&D. As a pivotal member of cross‑functional teams, you will serve as the go‑to expert for reliability, safety, and quality functions. You will lead Design for Reliability (DfR) initiatives, participate in design and risk reviews, and shape the development of cutting‑edge technologies. Collaborating with multidisciplinary teams, you will ensure that innovative solutions meet the highest safety and reliability standards, fostering impactful advancements in patient care. A Day in the Life
Leverage field experience and clinical knowledge to ensure the practical applicability and safety of our products in real‑world settings. Complete risk severity and occurrence determination and analyze risk‑benefit profiles for cardiac software medical products. Conduct risk analysis studies of new designs and processes. Compile and analyze performance reports and process control statistics; investigate and analyze variables affecting products and processes. Ensure corrective measures meet acceptable reliability standards. Analyze preliminary plans and develop reliability/safety engineering programs to achieve company, customer, and governmental safety objectives. Develop, coordinate, and conduct technical reliability/safety studies and evaluations of engineering design concepts and design of experiments (DOE) constructs. Recommend design or test methods and statistical process control procedures for achieving required levels of product reliability and safety. Propose changes in design or formulation to improve system and/or process reliability and product safety. Must Have: Minimum Requirements
To be considered for this role, please ensure the minimum requirements are evident on your resume. Bachelor’s degree in engineering, science or technical field with 4+ years of work experience in engineering and/or quality. OR advanced degree in engineering, science or technical field with 2+ years of work experience in engineering and/or quality. 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 (e.g., Nurse, Clinical Engineer, Field Technician, Technical Field Educator, Field Services for cardiac products). Personnel with at least 5 years of previous clinical experience related to cardiac therapy products. Nice to Have
Advanced degree in engineering or science. Proven understanding of product reliability/safety engineering principles. Strong understanding of and experience in the application of statistics, including experience with Minitab. Experience in a highly regulated industry, preferably implantable medical devices. Experience with 21 CFR Part 820 (Quality System Regulation), ISO 13485, etc. Experience in the application of Risk Management (ISO 14971) and hazard analysis and risk analysis techniques (e.g., PHA, HA, FTA, DFMEA). Ability to independently lead investigations to identify system/product failures, hazards, hazardous situations, and harms. Certified Software Reliability Engineer (CSRE). 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. Seniority level: Not Applicable Employment type: Full‑time Industries: Medical Equipment Manufacturing, Pharmaceutical Manufacturing, and Biotechnology Research Benefits
Vision insurance Medical insurance 401(k) Referrals increase your chances of interviewing at Planet Pharma by 2x.
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$60.00/hr – $85.00/hr (23‑month contract, pay depends on experience) In this exciting role as a Sr. Software Safety Engineer, you will have responsibility for ensuring our products exceed the safety and reliability requirements and expectations of patients, clinicians, regulators, and the business. This position offers an exciting opportunity to drive software reliability and safety engineering within dynamic new product development teams for R&D. As a pivotal member of cross‑functional teams, you will serve as the go‑to expert for reliability, safety, and quality functions. You will lead Design for Reliability (DfR) initiatives, participate in design and risk reviews, and shape the development of cutting‑edge technologies. Collaborating with multidisciplinary teams, you will ensure that innovative solutions meet the highest safety and reliability standards, fostering impactful advancements in patient care. A Day in the Life
Leverage field experience and clinical knowledge to ensure the practical applicability and safety of our products in real‑world settings. Complete risk severity and occurrence determination and analyze risk‑benefit profiles for cardiac software medical products. Conduct risk analysis studies of new designs and processes. Compile and analyze performance reports and process control statistics; investigate and analyze variables affecting products and processes. Ensure corrective measures meet acceptable reliability standards. Analyze preliminary plans and develop reliability/safety engineering programs to achieve company, customer, and governmental safety objectives. Develop, coordinate, and conduct technical reliability/safety studies and evaluations of engineering design concepts and design of experiments (DOE) constructs. Recommend design or test methods and statistical process control procedures for achieving required levels of product reliability and safety. Propose changes in design or formulation to improve system and/or process reliability and product safety. Must Have: Minimum Requirements
To be considered for this role, please ensure the minimum requirements are evident on your resume. Bachelor’s degree in engineering, science or technical field with 4+ years of work experience in engineering and/or quality. OR advanced degree in engineering, science or technical field with 2+ years of work experience in engineering and/or quality. 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 (e.g., Nurse, Clinical Engineer, Field Technician, Technical Field Educator, Field Services for cardiac products). Personnel with at least 5 years of previous clinical experience related to cardiac therapy products. Nice to Have
Advanced degree in engineering or science. Proven understanding of product reliability/safety engineering principles. Strong understanding of and experience in the application of statistics, including experience with Minitab. Experience in a highly regulated industry, preferably implantable medical devices. Experience with 21 CFR Part 820 (Quality System Regulation), ISO 13485, etc. Experience in the application of Risk Management (ISO 14971) and hazard analysis and risk analysis techniques (e.g., PHA, HA, FTA, DFMEA). Ability to independently lead investigations to identify system/product failures, hazards, hazardous situations, and harms. Certified Software Reliability Engineer (CSRE). 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. Seniority level: Not Applicable Employment type: Full‑time Industries: Medical Equipment Manufacturing, Pharmaceutical Manufacturing, and Biotechnology Research Benefits
Vision insurance Medical insurance 401(k) Referrals increase your chances of interviewing at Planet Pharma by 2x.
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