Share this Job
Apply now »

Title:  Senior Software Quality Engineer/Medical Devices

Requisition ID:  20686
Date:  Sep 4, 2022

Scottsdale, Arizona, US

Department:  R&D



Working at West means having an opportunity to work by the side of our patients and customers, our global team members and the communities in which we operate – which all help contribute to a Healthier World.


At West, we are by the side of patients. The work we do impacts patients’ lives each and every day – our products are a critical part of healthcare delivery and we are proud of the role we play to improve patient health. We work by the side of our team members. We come together as one global team to deliver for our customers and help them address their challenges. We are a diverse, close-knit community of professionals, where everyone has a voice and opportunity to learn and grow through mutual trust and respect. With a 95 year plus history, we have a track record for success, which includes reported sales of $2.14B in 2020. We serve by the side of our community. Giving back is in our DNA—our team members across more than 50 sites globally are involved with hundreds of charities that have special meaning to them through our West Without Borders team member-led giving program.


In this role, you will be responsible for providing software leadership that is influential and collaborative with new product development and software maintenance project teams. The primary focus is to support the on-time delivery of software development efforts that contribute to high quality, compliant, regulated devices available to the global market. This position also supports the maintenance and improvement of West’s software development processes.


Essential Duties and Responsibilities:

  • Lead and support all facets of software engineering through stages of software product lifecycle (Design, Verification and Validation Testing, Release, and Post-Market) for the software for medical devices.
  • Support cybersecurity team in conducting security review, updating and maintaining security policy and procedure to meet relevant industry standards and regulations (HIPAA, GDPR, HITRUST, etc.)
  • Provide software process leadership and guidance supporting product development.
  • Uses subject matter expertise in support of key technical reviews covering product Design, Development and Planning.
  • Supports internal and third-party audits of the software development processes.
  • Other duties as assigned

Basic Qualifications: 

  • Minimum, Bachelor's degree in: Computer Science, Software Engineering, or related field.
  • Minimum 5 years of experience in a software development environment, with technical software engineering experience (design, coding, testing).
  • Experience with Software Quality and Risk Management standards in medical devices, such as: IEC 62304, FDA 21 CFR 820, ISO 13485, and ISO 14971.
  • Software development or software engineering experience with medical or other regulated devices.

Preferred Knowledge, Skills and Abilities:

  • Experience with defect tracking and metrics
  • Experience using automated testing tools for continuous integration
  • Experience with development of embedded software and custom electronics
  • Experience integrating software, electronic hardware, and mechanical subsystems
  • Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
  • Support and contribute in Lean Sigma programs and activities towards delivery of the set target
  • Able to comply with the company’s safety policy at all times
  • Able to comply with the company’s quality policy at all times.


Travel Requirements:

  • Must be able to travel up to 10% of the time.



  • Can reside in the State of PA or Arizona







West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status.  If you have a special need that requires accommodation in order to apply to West, please send an email to  Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening and/or a pre-employment drug screening.

Apply now »