Medical Devices Program Manager (REMOTE/WEST COAST CANDIDATES)

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

Job summary

An established industry player in medical technology is seeking a Medical Devices Program Manager to lead process improvements and ensure compliance in software delivery. This remote position involves analyzing practices, collaborating across teams, and implementing efficient business processes. The ideal candidate will have a strong background in regulated healthcare environments and cloud software development. Join a forward-thinking company that values its employees and fosters a collaborative work culture. If you're ready to make a significant impact in the medical device sector, this opportunity is for you.

Qualifications

• 6+ years experience in a regulated healthcare/medical device environment.
• Practical knowledge of Agile methodologies and SDLC.

Responsibilities

• Analyze and refine software development and release processes.
• Manage projects using agile and/or SAFe methodologies.
• Develop and deliver training and create process documentation.

Skills

Regulated healthcare experience

Cloud software development

Agile methodologies

Project management

Communication skills

Education

Bachelor’s degree in computer science, business, or related field

Job description

Medical Devices Program Manager (REMOTE/WEST COAST CANDIDATES)

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

Base pay range

$75.00/hr - $80.00/hr

Direct message the job poster from Amerit Consulting

Lead Recruiting Specialist at Amerit Consulting

Our client, a US Fortune 250 company and a global Medical technology corporation serving customers in Clinical Labs, Healthcare 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)

Duration: 6 months + Contract to Hire

US West Coast applicants only

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 role focuses on analyzing practices in software delivery, identifying process improvements, gaining alignment across multiple functional areas, and producing a comprehensive implementation plan. They will support development teams through trainings and documentation.

The role requires a solid understanding of Quality Systems, applicable standards, and the ability to conduct independent discovery, collaboration, implementation, and rollout of processes and tooling.

KEY RESPONSIBILITIES

1. Process analysis, design, and execution.
2. Refine software development and release processes for cloud-based deployments of SaMD, SiMD, and MDDS.
3. Analyze impact of process changes and create implementation plans.
4. Drive tooling implementation to facilitate software delivery.
5. Validate tooling to meet standards, including evaluation of functionality, accuracy, and reliability.
6. Develop and deliver training and create process documentation and job aids.
7. Align with Quality, applying knowledge of FDA, cGMP, and related standards.
8. Maintain Design History Files and validation records.
9. Identify opportunities for process and tool improvements and implement changes.

Program Management

1. Serve as Program Manager for tooling delivery and software product delivery, with experience in process and tool usage.
2. Manage projects using agile and/or SAFe methodologies.
3. Identify risks/issues, develop mitigation plans, and communicate with stakeholders.
4. Provide Scrum Master leadership, coaching, mentoring, and training for Scrum teams.

REQUIRED SKILLS AND QUALIFICATIONS

• Bachelor’s degree in computer science, business, or related field.
• 6+ years experience in a regulated healthcare/medical device environment (compliance with 21 CFR 820.30, IEC 62304, ISO 14971, ISO 13485).
• Experience with cloud software development and SDLC.
• Practical knowledge of Agile methodologies.
• Leadership experience in cross-functional teams.
• Strong communication skills and ability to manage multiple projects.

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.