Senior Software Quality Engineer

USA-MiniMed Distribution Corp. 1018; Los Angeles (CA); Híbrido; USD 97 000 - 165 000; Tempo integral

Resumo da oferta

MiniMed is seeking a Senior Software Quality Engineer in Northridge, CA, a hybrid role focusing on embedded firmware quality and risk management within the core product team. You will drive quality into product development and collaborate with Regulatory, R&D, Marketing and post-market Quality to implement continuous improvement strategies.

Responsibilities include risk management activities (FMEA & hazard analysis), design controls, change control, and cross-functional collaboration to ensure

Qualificações

• Bachelor's degree or Advanced Degree in a technical field with relevant experience.
• 4+ years in Quality, Engineering and/or Software Development (or 2+ with advanced degree).

Responsabilidades

• Participate in product risk management activities including FMEA and hazard analysis.
• Drive quality compliance with R&D, including design controls, risk management and change control.
• Review design input/output, requirements, design documents, code reviews, V&V reports.
• Manage and triage software issues with R&D team.
• Support Quality Management System reviews and internal/external audits.

Conhecimentos

Embedded firmware quality

Risk management (FMEA)

Design controls

Change control processes

Regulatory documentation

Formação académica

Bachelor's degree in Engineering, Science or Technical field

Advanced Degree in Engineering, Science or Technical field

Descrição da oferta de emprego

About the Role

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.

Responsibilities may include the following and other duties may be assigned.

Hybrid role based in Northridge, CA

• 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

Must Have: Minimum Requirements

To be considered for this role, please ensure the minimum requirements are evident on your resume.

• 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.

Nice To Have:

• 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.
• Candidate must have strong verbal and written communication skills.

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

Benefits & Compensation

MiniMed offers a competitive salary and flexible benefits package

At MiniMed, we put people first. A commitment to our employees lives at the core of our values: We recognize their contributions. They share in the success they help create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every stage of your career and life.

Salary ranges for U.S (excl. PR) locations (USD):$87,000.00 - $149,000.00

For roles located in California, Seattle WA, Washington DC, Boston MA, and New York City, the salary range is $97,000 - $165,000 USD.

Actual compensation may vary based on factors including experience, education, certifications, skills, market conditions, internal equity, and geographic location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

This position is eligible for a short-term incentive called the Short Term Incentive (STI).

At MiniMed, we are committed to supporting the well-being and financial security of our employees. Regular employees working 20 or more hours per week are eligible for a robust benefits package, including health, dental, and vision insur