Process Architect- Medical Devices SiMD SaMD

Company: A-Line Staffing Solutions
Location: San Diego
Posted on: May 8, 2025

Job Description:

$70-77/hr W2 for the contract term

Want to make an application Make sure your CV is up to date, then read the following job specs carefully before applying.

Temp to Perm position

Remote position (opportunity to work in San Diego office if desired)

US West Coast applicants only

Travel may be required. Domestic travel only. 5% of work time.

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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 our 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 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 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.



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.



Industry Title

Sr Staff Engr, Product Development



Contract to hire position

Yes

Keywords: A-Line Staffing Solutions, Hemet , Process Architect- Medical Devices SiMD SaMD, Professions , San Diego, California