Medical Devices Program Manager (REMOTE/WEST COAST CANDIDATES)

Our client, a US Fortune 250 company and a global Medical technology corporation serving customers in Clinical Labs, Health care research & Pharmaceutical industry, seeks an Medical Devices Program Manager

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NOTE: THIS IS REMOTE ROLE & ONLY W2 CANDIDATES (NO C2C/1099)

*** Candidate must be authorized to work in USA without requiring sponsorship ***

Position: Medical Devices Program Manager(Job Id - # CFNJP00051124)

Location: San Diego CA 92130 (Remote)

Duration: 6 months + Contract to Hire

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 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.

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.

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If you're looking for rewarding employment and a company that puts its employees first, we'd like to work with you. We're driven, people driven.

Bhupesh Khurana

Senior Technical Recruiter

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Amerit Consulting is an extremely fast-growing staffing and consulting firm. Amerit Consulting was founded in 2002 to provide consulting, temporary staffing, direct hire, and payrolling services to Fortune 500 companies nationally; as well as small to mid-sized organizations on a local & regional level. Currently, Amerit has over 2,000 employees in 47 states. We develop and implement solutions that help our clients operate more efficiently, deliver greater customer satisfaction, and see a positive impact on their bottom line. We create value by bringing together the right people to achieve results. Our clients and employees say they choose to work with Amerit because of how we work with them - with service that exceeds their expectations and a personal commitment to their success. Our deep expertise in human capital management has fueled our expansion into direct hire placements, temporary staffing, contract placements, and additional staffing and consulting services that propel our clients businesses forward.

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