Process Architect

Pyramid Consulting, Inc; San Diego (CA); Remote; USD 100,000 - 125,000; Full time

Job summary

An established industry player is seeking a talented Process Architect for a remote contract opportunity. This role involves analyzing and refining software development processes, particularly in the medical technology sector. You will work closely with cross-functional teams to ensure compliance with industry standards while driving the implementation of effective tooling for product delivery. If you have a strong background in program management and process analysis, and are passionate about improving operational efficiencies, this position offers a unique chance to make a significant impact in a dynamic environment.

Benefits

Health insurance (medical, dental, vision)

401(k) plan

Paid sick leave

Qualifications

• 6+ years of experience in a government-regulated healthcare environment.
• Strong understanding of FDA regulations and compliance standards.

Responsibilities

• Analyze and refine software development processes for cloud-based deployments.
• Drive implementation of tooling and create comprehensive documentation.

Skills

Process Analysis

Design History Files

Program Management

Agile Software Development

Communication Skills

Analytical Skills

Education

Bachelor’s degree in computer science

6+ years in healthcare/medical device environment

Job description

Pyramid Consulting, Inc provided pay range

This range is provided by Pyramid Consulting, Inc. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$70.00/hr - $78.00/hr

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.

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.

Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

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Seniority level

• Seniority level

  Not Applicable

Employment type

• Employment type

  Contract

Job function

• Industries

  Hospitals and Health Care

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