Sr SW Quality Assurance Engineer, medical devices, remote

Sr SW Quality Assurance Engineer, medical devices, remote

This role both actively participates in the development of product and non-product (e.g., automated manufacturing test systems) software and firmware by serving as a core team member.

Job Functions

Serves as a core team member on software/firmware product development teams by providing technical leadership and direction. Responsible for the risk management file, compliance with design control regulations, development of design requirements, architecture specifications, and design verification/validation (including unit and integration testing).

Chair the change control board within projects for change requests and defects identified during the course of development.

Provide valuable technical feedback in code reviews.

Lead (technical expert) and oversee/approve investigations of software/firmware related complaints, defects identified during development, or from manufacturing nonconformities, audit responses and CAPAs to identify root cause and corrective actions in a timely manner.

Generates, maintains and updates risk management documentation throughout the life cycle of a product.

Ensures compliance with software / firmware development and non-product software validation procedures.

Contributes to successful regulatory audits by coordinating back room / front room activities or serving as a subject matter expert.

?Knowledge, Skills and Abilities Required

Experience with developing software or firmware in the medical device industry including demonstrated proficiency in meeting the requirements of IEC 62304.

Develop and maintain strong, positive business relationships with key internal customers such as R&D, Clinical, Regulatory Affairs, and Operations to fulfill design development activities, support audits / inspections, and develop and implement plans that will ensure company compliance with regulatory requirements.

Collaborate with other areas within Quality to achieve quality objectives.

Exhibit strong leadership skills showing ability to influence both peers and other team members.

Exhibit Excellent written and verbal communication skills.

Demonstrate an ability to prioritize and plan activities.

Possesses in depth knowledge of pertinent regulations (e.g. ISO 13485, 21 CFR Part 820, etc.) to assure the documentation of all company-wide functions meet these requirements and, when necessary, identify compliant, effective and efficient approaches to fulfilling such requirements.

This is not a sw test engineer role.

Required Qualifications

• Education: BS in Computer Engineering, Computer Science, Electrical Engineering (with education/experience in software development) preferred, or other related degree.
• Advanced degree or professional certifications are valued.
• Experience with implantable medical devices is a major plus.
• 6+ years of experience
• Sustained record of performance during tenure in previous position.
• Has full accountability for representing Quality Engineering on project teams.
• Ability to present procedural requirements and design deliverables clearly during audits and regulatory inspections.

Why is This a Great Opportunity

Work on novel neuromodulation devices for the treating of epilepsy and sleep apnea.
This is a full remote role.