Senior Product Development Manager – Credit Cards
Wells Fargo
SDLC
Senior Manager, Design Quality Assurance - Continuous Improvement
Diabetes Youth Families
full-time
Posted on:
Origin: • 🇺🇸 United States • California, Massachusetts
Visit company websiteSalary
💰 $150,300 - $225,450 per year
Job Level
Senior
Tech Stack
SDLC
About the role
- Drive and implement continuous improvement initiatives to optimize product development processes in partnership with cross-functional process owners
- Evaluate and optimize processes to ensure compliance with FDA, ISO 13485, ISO 14971, IEC 62304, and other regulatory standards
- Collaborate with internal standards teams to interpret and implement evolving industry and regulatory standards
- Partner with enterprise and cross-functional teams (R&D, Systems, Regulatory, Quality, Manufacturing, IT) to help drive systems/tools improvement initiatives and help resolve process inefficiencies
- Develop and track key performance indicators (KPIs) to measure the impact and sustainability of improvement initiatives
- Lead change management and training efforts to embed a culture of continuous improvement across the organization
- Support audit and inspection readiness by ensuring robust documentation and traceability of process improvements
- Lead and/or provide robust support for CAPAs as quality partners, ensuring timely investigations, root cause analysis, and effective implementation of corrective actions
- Benchmark internal processes against industry best practices and recommend enhancements
- Champion digital transformation opportunities within design quality systems
- Introduce and implement the best practices for the Software Development Life Cycle (SDLC), including requirements management, design verification, software risk management, and configuration control
- Collaborate with software engineering and quality teams to ensure alignment with IEC 62304 and other relevant software standards
- Drive initiatives that reduce development cycle times and improve execution efficiency without compromising quality or compliance
- Promote a proactive quality culture that supports innovation and accelerates time to market for new products
Requirements
- Bachelor's degree in engineering, Life Sciences, or related field (master's preferred)
- 8+ years of experience in the medical device industry, with strong knowledge of design controls and quality systems
- Proven track record in leading cross-functional continuous improvement projects
- Deep understanding of regulatory standards (FDA QSR, ISO 13485, ISO 14971, IEC 62304, etc.)
- Experience implementing SDLC best practices in regulated environments
- Lean Six Sigma certification (Green Belt or higher) preferred
- Excellent communication, leadership, program management and stakeholder management skills
- Effective verbal and written communication skills.
- Experience collaborating and communicating with individuals at multiple levels in an organization.
- Ability to prioritize and manage critical project timelines in a fast-paced environment.
- Must be able to handle multiple responsibilities concurrently.
- Conflict resolution skills including persuasive management techniques required.
- Strong analytical and problem-solving skills.
- Able to work effectively in a high-stress, high-energy environment.
- Ability to influence people and projects in a fast-moving environment.
