Software Verification & Validation Engineer

Job Description

PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements.

Our goal is to skyrocket our clients’ success, and you can be a part of our team’s achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East.

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

The Experience

With operations spanning the globe and featuring a multi-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 our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents.

We are firm believers in coach ing and developing the next generation of industry leaders and influencers. As such, you will not only be offered compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn.

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

Your Role

The Software Validation Engineer is responsible 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 software V&V activities are carried out in compliance with applicable regulations and standards.

Responsibilities

• Lead the S oftware Verification and Validation (V&V) activities for medical equipment 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’s degree in computer science, Software Engineering, Computer Engineering, or similar discipline.
• 7 years or more of experience in Software Quality, testing, verification and validation in FDA regulated industries.
• Experience with design automated testing.
• Some experience / knowledge with C++ and Python programming.
• Hands-on experience with software V&V methodologies, processes & practices for software V&V, as well as troubleshooting.
• Hands-on experience with Software Development Life Cycle.
• Experience testing software systems.
• Experience testing medical devices that contain embedded software.
• Experience with MES and / or other manufacturing applications.
• Experience with testing software, software quality and test protocol development
• Strong familiarity with FDA regulations and guidance for software validation.
• Strong familiarity with IEC 62304 standard.
• Strong familiarity with ISO 14971 risk management standard.
• Ability to work well in a fast-paced environment.
• Ability to work independently with minimal supervision.
• Effective interpersonal and communication skills.
• Able to support Pacific or Central Standard Times working hours.

Benefits

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

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

• Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents.
• Insurance options for Employee Assistance Programs, Basic Life Insurance, Short / Long Term Disability and more.
• 401(k) and 401(k) matching.
• PTO, Sick Time, and Paid Holidays.
• Education Assistance.
• Pet Insurance.
• Discounted Fitness Rates.
• Financial Perks and Discounts.

Adhering to the requirements of California's law on salary transparency, the salary bracket for this role is set between $135,000 - $155,000 annually.

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

Equal Opportunity Employment Statement :

PSC is committed to is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment.

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

Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants 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, leaves of 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 without regard to an applicant’s, employee’s, or intern’s actual or perceived : race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law.

LI-IT1

Requirements

Bachelor’s degree in computer science, Software Engineering, Computer Engineering, or similar discipline. 7 years or more of experience in Software Quality, testing, verification and validation in FDA regulated industries.

Experience with design automated testing. Some experience / knowledge with C++ and Python programming. Hands-on experience with software V&V methodologies, processes & practices for software V&V, as well as troubleshooting.

Hands-on experience with Software Development Life Cycle. Experience testing software systems. Experience testing medical devices that contain embedded software.

Experience with MES and / or other manufacturing applications. Experience with testing software, software quality and test protocol development Strong familiarity with FDA regulations and guidance for software validation.

Strong familiarity with IEC 62304 standard. Strong familiarity with ISO 14971 risk management standard. Ability to work well in a fast-paced environment.

Ability to work independently with minimal supervision. Effective interpersonal and communication skills. Able to support Pacific or Central Standard Times working hours.