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Sr Engr

Irvine, CA 92614

Posted: 03/12/2024 Employment Type: Contract Job Category: Engineering Job Number: 599475 Is job remote?: No Country: United States

Job Description


Target PR Range: 50-60/hr
*Depending on experience

Summary:

The main function of this Sr. Software Quality Engineer is to lead all software engineering activities relating to the validations of several production equipment with custom software. The main purpose of this role is to apply knowledge of software quality engineering to assess risk, execute validation activities and develop/approve software documents.

Job Responsibilities:
  • Investigate complex product / non-product software quality and compliance issues (e.g. software deviations/failures) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports.
  • Assess Risk Management activities including authoring of Software Hazard Analysis for complex projects / systems / test equipment in partnership with cross-functional teams; provide recommendations for improvements.
  • Develop complex software documentation (e.g. Protocols, Reports, Hazard Analysis) for product or non-product software validation deliverables utilizing engineering knowledge.
  • Collaborate with stakeholders on the Code Review process for product software or custom manufacturing test equipment.
  • Perform dry-runs and execution of Software Validation Protocols.
  • Train, coach, and guide other employees on software documentation.
  • Other Incidental duties as required.

Required Skills:
  • Proven expertise in usage of MS Office Suite;
  • Strong documentation, communication and interpersonal relationship skills including negotiating and relationship management skills.
  • Working knowledge and understanding of statistical techniques.
  • Substantial understanding and knowledge of principles, theories, and concepts relevant to Software Development Lifecycle related to Software Quality Engineering (e.g., CQE body of knowledge) for product and non-product software.
  • Substantial knowledge of business acumen products and software technologies
  • Strong problem-solving, organizational, analytical and critical thinking skills
  • Substantial understanding of processes and equipment used in assigned work
  • Good leadership skills and ability to influence change
  • Knowledge of and adherence to related procedures (e.g., Cybersecurity procedures related to IT systems, manufacturing equipment or product software).
  • Strict attention to detail
  • Ability to interact professionally with all organizational levels
  • Ability to manage competing priorities in a fast paced environment
  • Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

Level of Independence:
  • Works independently without close supervision.
  • Compares and evaluates possible courses of action after considering various possibilities.
  • Applies knowledge in following procedures or in determining which procedures to follow or determining whether specified standards are met.
  • Considers the cause and effect of activities.
  • Determines or effectively recommends course of action after considering potential risks of alternatives.
  • Makes decisions in the face of different alternatives and without formulas or guidelines or with guidelines that are not complete and exhaustive.

Education/Experience:
  • Bachelor's degree in Engineering with minimum of 5 years of experience, or Master's degree in Engineering with a minimum of 4 years of experience.
  • Previous experience with software verification and validation activities in a medical device industry.

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Irvine, CA

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Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.