Senior Software Quality Engineer

MiniMed • Northridge, CA

5d • Hybrid

About The Position

The Senior Software Quality Engineer works as part of the core product team to collaboratively drive the software development activities for embedded firmware and lead the risk management assessment and Quality deliverables. Candidate will work with the R&D team to drive quality into product development, including collaborating with Regulatory, R&D, Marketing, Medical Safety, and post-market Quality, and implement strategies that enable continuous improvement. Ready to make an impact? Apply now and join our team! Responsibilities may include the following and other duties may be assigned. Hybrid role based in Northridge, CA

Requirements

• Bachelor’s degree in Engineering, Science or Technical field with 4+ years of relevant experience in Quality, Engineering and/or Software Development OR Advanced Degree in Engineering, Science or Technical field with 2+ years of relevant experience in Quality, Engineering and/or Software Development.
• Strong verbal and written communication skills.

Nice To Haves

• Understanding of software development life cycle processes as applied to embedded firmware within the regulated medical device industry, and be familiar with IEC 62304, 13485, 14971, and FDA QMSR.

Responsibilities

• Participate in product risk management activities including software Failure Mode Effects Analysis (FMEA) and product hazard analysis.
• Drive quality compliance with R&D team, including design controls, risk management, and change control processes, and engaging as Quality core team member with cross functional team members.
• Participate in technical and product design reviews.
• Review design input and output artifacts including requirements, design documents, code reviews, verification and validation reports.
• Manage and triage software issues with R&D team
• Participate and support Quality Management System reviews of Standard Operating Procedures which align with US and international standards
• Ensure that all requirement traceability is met and documented appropriately
• Strong verbal and written communication skills with an ability to effectively communicate at multiple hierarchical levels in the organization.
• Support CAPAs as needed, and post-market team for FCAs or HRAs as needed
• Support internal and external audits

Benefits

• health, dental, and vision insurance
• Health Savings Account
• Healthcare Flexible Spending Account
• life insurance
• long-term disability leave
• dependent daycare spending account
• incentive plans
• 401(k) plan with company match
• short-term disability coverage
• paid time off and holidays
• Employee Stock Purchase Plan
• Employee Assistance Program
• Non-qualified Retirement Plan Supplement
• Capital Accumulation Plan

What This Job Offers

• Job Type: Full-time
• Career Level: Senior