Software Engineering Manager-FDA in Alameda, CA at Johnson Service Group

Date Posted: 2/10/2021

Job Snapshot

Job Description

JobID: 382415

Our client in Oakland, CA is seeking a Software Development Engineering Manager with FDA/Medical Device experience for a long-term contract position.  This exciting role will have you working on advanced R&D product development in the medical device industry.  With a high level of independence, coordinate activities to support new product launch or launches and/or upgrades to existing products.  The Program Manager should have experience in medical software product development with experience dealing with the regulatory, quality and safety aspects, plus experience and thorough understanding of the software development process required by FDA.

Responsibilities include:

  • Strategic Develop: Product requirements and programs to meet strategic needs of the business. This position is responsible for the product definition and development, and preparation of all departments for a successful timely launch of a quality product meeting the business and product strategies.
  • Communicate product development program status to development teams and company management. This position is highly visible and accountable, responsible for directing, and reporting to senior management, the activities in the launch for a new product.
  • Coordinate activities between operational and commercial organizations from project initiation through launch. This position will provide leadership to a project team, integrating activities across all departments, with influence across departmental lines.
  • Tactical Hold: Regular project review meetings to coordinate and document the activities of all departments contributing to a product launch, including QA/RA, Marketing, R&D, Commercial, and Finance.
  • Generate and control various documentation as appropriate, such as product specification, Design and Development plans, product configuration, resource assignments, Bill of Materials, etc.
  • Develop product cost/budget estimates working with R&D and Finance.
  • Provide input to the PMP process and manage development costs on a program.
  • Regulatory: Responsible for implementing and maintaining the effectiveness of the quality system in an FDA regulated environment.

Qualifications:

  • Bachelor’s degree or higher in computer science, information technology or related field, or business degree with applicable experience.
  • Evidence of continuing education, such as technical certifications, a plus
  • Experience working in an FDA regulated industry is required.
  • Minimum 7 years’ experience.
  • Knowledge of Program Management tools such as project scheduling, work breakdown structures, time and cost reporting is required. 
  • Local to the Bay Area preferred.  Work will be remote during COVID lockdown.

 #D800




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