Software Verification & Validation Engineer

Job Description

PSC Biotech provides the life sciences withessential services to ensure that health care products are developed, manufactured, and

distributed to the highest standards, in compliance with all applicable regulatoryrequirements.Our goal is to skyrocket our clients’ success, andyou can be a part of our team’s achievements.

Employing a global team of skilledprofessionals and experts that span across strategically located offices in NorthAmerica, Europe, Asia and the Middle East,

We are proud of the roles we have fulfilled to helpour clients achieve success.

TheExperience

With operations spanning the globe and featuring amulti-cultural team, PSC Biotech is passionate about bringing the best and brightest

together to form something truly special. When you make the decision to join ourteam, you will be offered the ability to feel inspired in your career, explore yourprofessional passions, and work alongside a group of people who will value and nurture yourtalents.

We are firm believers in coaching and developing thenext generation of industry leaders and influencers. As such, you will not onlybe offered compensation and benefits structure that rewards you, but also beprovided with the tools that will help you grow and learn.

At PSC Biotech, it’s about more than just ajob it’s about your career and your future.

Your Role We are looking for a Software Verification& Validation Engineer. The Software Validation Engineer isresponsible for leading and performing software verification and validation (V&V)activities to ensure the products are consistently meeting their intended specifications,that software systems meet all the design specifications, and that softwareV&V activities are carried out in compliance with applicable regulations and standards.

Responsibilities

• Leadthe Software Verification and Validation (V&V) activities for medicalequipment embedded software.
• Design, implement and execute software V&V test protocols / test cases at system level, integration level and unit level.
• Develop software test tools for software V&V as needed.
• Write software V&V reports and resolve software V&V deviations.
• Lead the software risk management activities, e.g., software risk management plan, hazard identification, risk analysis, mediation controls, and software risk management reports.
• Establish traceability between requirements, risk analysis and test cases.
• Review system and software requirements to ensure test-ability and completeness.
• Partner with key stakeholders (e.g., R&D, Manufacturing, Quality & Regulatory, and IT) to drive testing and validation strategies, improve productivity, maintain compliance, and meet the project timelines.
• Provide expertise in testing principles and methods to drive robust testing, validation, and support of technical solutions.
• Guide team members and partner with vendors to develop and document test strategy, scenarios, and protocols.
• Ensure software V&V activities comply to regulations and meets intended use.
• Communicate project updates and progress to management.
• Additional projects and / or duties as assigned

Requirements

• Bachelor’sdegree in computer science, Software Engineering, Computer Engineering, orsimilar discipline.
• 7years or more of experience in Software Quality, testing, verification andvalidation in FDA regulated industries.
• Experiencewith design automated testing.
• Someexperience / knowledge with C++ and Python programming.
• Hands-onexperience with software V&V methodologies, processes & practices forsoftware V&V, as well as troubleshooting.
• Hands-onexperience with Software Development Life Cycle.
• Experiencetesting software systems.
• Experiencetesting medical devices that contain embedded software.
• Experiencewith MES and / or other manufacturing applications.
• Experiencewith testing software, software quality and test protocol development
• Strongfamiliarity with FDA regulations and guidance for software validation.
• Strongfamiliarity with IEC 62304 standard.
• Strongfamiliarity with ISO 14971 risk management standard.
• Abilityto work well in a fast-paced environment.
• Abilityto work independently with minimal supervision.
• Effectiveinterpersonal and communication skills.
• Ableto support Pacific or Central Standard Times working hours.

Benefits

Offering a full suite ofbenefits, PSC Biotech is firmly focused on diligently investing in ouremployees who enable our company to fulfill our mission and achieve success.

Wewant to promote balance, so you not only enjoy your work, but also have the timeand resources to live your life happily and healthily.

• Medical, Dental, andVision - PSC pays 100% of all qualifying employee medical premiums and 50% forqualifying dependents.
• Insurance options forEmployee Assistance Programs, Basic Life Insurance, Short / Long Term Disabilityand more.
• 401(k) and 401(k) matching.
• PTO, Sick Time, and PaidHolidays.
• Education Assistance.
• Pet Insurance.
• Discounted Fitness Rates.
• Financial Perks andDiscounts.

Adhering to the requirements ofCalifornia's law on salary transparency, the salary bracket for this role isset between $135,000 - $155,000 annually.

The offered salary may beadjusted based on various factors such as the applicant's qualifications,skills, and professional experience.

Equal OpportunityEmployment Statement : PSC iscommitted to is committed to a policy of Equal Employment Opportunity withrespect to all employees, interns, and applicants for employment.

Consistentwith this commitment, our policy is to comply with all applicable federal,state, and local laws concerning employment discrimination.

Accordingly, theCompany prohibits discrimination against qualified employees, interns andapplicants in all aspects of employment including, but not limited to : recruitment, interviewing, hiring (or failure or refusal to hire), evaluation,compensation, promotion, job assignment, transfer, demotion, training, leavesof absence, layoff, benefits, use of facilities, working conditions,termination and employer-sponsored activities and programs, including wellness,social and recreational programs.

Employment decisions will be made withoutregard to an applicant’s, employee’s, or intern’s actual or perceived : race,color, religion, sex (including pregnancy, gender identity, and sexualorientation), national origin, age (40 or older), disability, geneticinformation, or any other status protected by law.

LI-IT1