Engineering Program Manager

Engineering Program Manager

Position duration: Initially 5 months, with a potential extension to 12 months or more.

Pay Range: $53-67.50/hr.

Hours: Full-time (40 hours per week).

Education Requirement: Bachelor’s degree (preferably in a related field).

Experience: 10 years of experience is the general expectation, candidates with exceptional FCA experience may be considered with less experience.

Work Location: Remote

Interviews: Likely 2 rounds via Teams.

Key Candidate Requirements:

1. FCA Experience in Medical Devices: Proven experience in managing and closing Field Corrective Actions (FCAs) within the medical device industry.
2. FCA Activities: Hands-on experience with FCA bounding, scoping, FCA plans, execution, closure, and termination.
3. Regulatory Submissions: Experience with 806 submissions, as well as regulatory and notified body submissions related to FCAs.
4. Ongoing FCA Management: Ability to manage and support multiple FCAs in progress, including identifying gaps, remediation, and closure.
5. Collaboration: Strong ability to work cross-functionally with different teams to support FCA efforts.
6. Technical Writing Skills: Ability to produce clear, accurate, and well-documented FCA reports.
7. Advanced Excel Knowledge: Strong proficiency in Excel for data analysis, reporting, and tracking FCA progress.
8. Postmarket Strategy Experience: Familiarity with postmarket strategies, particularly related to diabetes products.

Job Responsibilities:

• Prepare Product Bounding for FCAs: Develop and document product bounding information for identified FCAs.
• Strategy Development: Create and execute strategies for the planning, execution, and closure of FCAs.
• Regulatory Compliance: Ensure all FCA activities comply with international regulations (FDA, EU MDR, ISO 13485).
• Maintain FCA Records: Keep detailed records of field corrective actions, product recalls, and customer notifications to meet regulatory standards.
• Cross-functional Guidance: Provide leadership and guidance to internal teams (Quality Assurance, Regulatory Affairs, R&D, Manufacturing, Customer Service) on FCA-related matters.
• Collaborate with Internal & External Stakeholders: Work closely with stakeholders across the enterprise and with external partners to ensure corrective actions are effectively implemented and communicated.
• Report FCA Activities: Prepare and submit FCA reports to regulatory bodies, ensuring all activities align with FDA and other regulatory requirements.
• Remediation & Closure Support: Work with the FCA team to close ongoing FCAs and provide remediation support as necessary.

Required Technical Skills and Qualifications:

Experience:

• 10+ years of experience in the medical device industry with a strong background in FCA, CAPA, or product quality management processes.
• Proven ability to lead FCA and CAPA processes within a regulated industry.

Regulatory Knowledge:

• Solid understanding of FDA regulations (21 CFR Part 820), ISO 13485, EU MDR, and other relevant medical device regulations.

Project Management & Problem-Solving:

• Strong project management skills with the ability to manage multiple priorities, meet deadlines, and handle complex problems.
• Excellent problem-solving and analytical abilities, including root cause analysis and corrective action implementation.

Communication Skills:

• Exceptional written and verbal communication skills to effectively collaborate with cross-functional teams and external partners.
• Ability to create clear, concise, and accurate documentation.

Technical Proficiency:

• Strong proficiency in Microsoft Office Suite (Excel, Word, PowerPoint).
• Experience with Quality Management Systems (QMS) and strong technical writing capability.