Responsibilities

• Author validation plans, protocols, software risk analyses for a medical device.
• Execute validation testing based on product requirements.
• Create, review and approve reports for V&V software testing and test scripts.
• Collaborate with firmware and software R&D engineers on improvements or new products.
• Coach and mentor junior team members on current best practices.
• Lead and participate in project teams assigned to new products.
• Support and investigate customers’ complaints related to product software.
• Involved in monitoring software anomalies.

Qualifications

• Bachelor’s degree in Computer Science, Software Engineering, or related field, or equivalent experience.
• A minimum of 7+ years of recent medical device experience.
• Experience writing and executing validation/verification plans, protocols, and software risk analysis on Medical Devices.
• Medical Device experience covering embedded software.
• Strong cross-functional communication skills.
• Strong written skills to define and document V&V outputs.
• Experience with scripting or programming (Python, C, or similar).
• Experience in automation frameworks.
• Experience in Threat Modeling and Software Risks.
• Working knowledge of FDA, Software Validation Guidance, 21 CFR part 820, IEC 62304, and IEC 82304-1.
• Knowledge of software quality and regulatory compliance (ISO 13485, IEC 62304) is a plus.
• Excellent written and verbal communication skills.

Benefits Element Science offers a very competitive salary and benefits package including, but not limited to:

• Stock Options
• 90% employer-paid medical, dental, and vision insurance
• Company-paid Basic Life Insurance
• 401(k) retirement plan (Traditional and Roth)
• Competitive Paid Time Off
• Paid Holidays
• FSA (Flexible Spending Accounts)
• HSA (Health Savings Account)
• Employee Assistance Program through PEO

The salary for this exempt-level position will be based on experience and qualifications within an established pay range.

• Pay range: $140,000 - $150,000 + Bonus

Element Science is an Equal Opportunity Employer. All candidates will be evaluated on the basis of their qualifications for the job in question. We do not base our employment decision on an employee's or applicant's race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), political affiliation, military service, or other non-merit-based factors prohibited by local, state, or federal law.

In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire. We are not able to sponsor individuals for employment visas for this job. At this time, we are unable to offer relocation assistance at Element Science.