Job Description

Job Description

Immediate need for a talented Process Architect- Medical Device. This is a 06+ Months Contract to Hire 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:25-85987

Pay Range: $65 - $70/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 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.
• 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.

Key Requirements and Technology Experience:

• Skills- Process Design & Compliance Expertise in Medical device -SAMD SIMD, MDDS.
• 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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