Job Description

Immediate need for a talented Process Architect . This is a 06+ Months Contract opportunity with long-term potential and is located in San Diego, CA (Remote) . Please review the job description below and contact me ASAP if you are interested.

Job ID:25-70222

Pay Range: $70 - $78/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).

Key Responsibilities:

• Process Analysis, Design and Execution
• Refine the software development and release processes to support frequent cloud-based deployments of SaMD (Software as a Medical Device), SiMD (Software in a Medical Device), and MDDS (Medical Device Data Systems).
• Analyze the impact of process changes, and create implementation plans to roll out new processes.
• Drive the implementation of tooling to facilitate software product delivery.
• Conduct and document validation to ensure that tooling meets the required standards and specifications.
• This includes evaluating the functionality, accuracy, and reliability of the tools used to support product development.
• Create and deliver training to all functional areas impacted by the changes.
• Create comprehensive process documentation and job aids for each roles leveraging these tools.
• Align with the Client’s Quality organization. Apply knowledge and understanding of FDA, cGMP, and other concepts, practices, codes, and procedures within the industry.
• Maintain accurate Design History Files and up-to-date records of all validation activities.
• Identify opportunities for improving the processes and tools. Implement changes to enhance their effectiveness.
• Program Management
• The person in this role will serve as a Program Manager for the delivery of tooling, and will occasionally serve as a Program Manager for the delivery of the client’s Software products for direct experience with process and tool usage.
• Manage software delivery projects using agile and/or SAFe methodologies.
• Facilitate identification of program risks/issues, develop and assign responsibility for mitigation/resolution actions; manage mitigation plans.
• Synthesize critical information and communicate business implications to stakeholders.
• Provide Scrum Master servant leadership in the form of coaching, mentoring and training for scrum teams
• Analytical and Problem-Solving Skills
• Strong attention to detail, with the ability to identify and address issues in documentation and validation processes.
• Ability to assess complex situations, develop effective remediation plans, and implement solutions that enhance compliance and efficiency.
• Communication and Collaboration
• Excellent verbal and written communication skills, with the ability to convey complex information clearly and concisely.
• Proven ability to work effectively with cross-functional teams, fostering a collaborative and cooperative work environment.
• Work closely with engineering, product management, quality assurance, and IT to ensure that remediation efforts are aligned with the company's objectives.
• The following are qualifications specific to the available position(s) for which this role applies.
• These provide position specific context for the type of work to be performed and the required domain knowledge.

Key Requirements and Technology Experience:

• Skills- Design History Files, Program Management, 21 CFR 820.30 or IEC 62304, ISO 14971 or ISO 13485, Process Analysis.
• This position will engage with business stakeholders to validate tools in which we use to manage and deliver clinically oriented applications and services.
• Bachelor’s degree in computer science, business, or related field
• 6+ years working in a government-regulated, healthcare/medical device environment (working in compliance with 21 CFR 820.30, IEC 62304, ISO 14971, ISO 13485)
• Experience with cloud-hosted software development, delivering products within an end-to-end software development life cycle (SDLC).
• Practical knowledge and application of Agile software development principles.
• Experience in leading cross-functional teams toward operational objectives.
• Demonstrated ability to identify operational efficiencies and opportunities.
• Strong communication skills with ability to effectively deliver complex messages and to teach new concepts.
• Ability to manage multiple project deployments and integrations.
• Experience in setting priorities in a fast-paced, rapidly changing environment.
• Experience working with matrixed resources within assigned programs and/or projects.
• Skilled in meeting facilitation, action item traction and follow up.
• Certified SCRUM Master Certification (CSM) desired.

Our client is a leading medical technology Industry, and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.

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