Our client, a leading Medical Devices Manufacturing Company is looking for Process Architect - Sr Staff Engineer[Product Development] and This is for an initial duration of 06 Months Contract – Remote Role.

Job Title: Process Architect - Sr Staff Engineer[Product Development]

Job Id: 25-08061

Location: Remote Role

Duration: 06 Months Contract

Position Type: Hourly Contract Position (W2 only)

• Remote position (opportunity to work in San Diego office of desired)
• Travel may be required. Domestic travel only. 5% of work time.
  
  

Position Overview

• The Process Architect is responsible for proposing, collaborating on, and rolling out efficient, compliant business and quality processes.
• The person in this role will focus on analyzing practices in the delivery of software, identifying process improvements, gain alignment across multiple functional areas and produce a comprehensive implementation plan.
• They will support the development teams and their stakeholders through trainings and documentation.
• The person in this role will develop a solid understanding of CLIENT's Quality System, applicable standards, and conduct independent discovery work, collaborative work, implementation and rollout of processes and associated tooling.
  
  

Accountabilities

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 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 CLIENT Software products for direct experience with process and tool usage.
  
  

General Qualifications

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.
  
  

The hourly rate range for this position is between $75 - $78/ hour, without benefits

Compensation: Factors which may affect starting pay within this range may include geography/market, skills, education, experience and other qualifications of the successful candidate.

Qualified candidates please send your word format updated resume at the earliest to Pavan: [email protected] [732-272-0382] OR Sangeeth: [email protected] [732-272-0281]

Thank You.