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Title:  Sr. Systems Engineer, R&D, Medical Devices

Requisition ID:  51930
Date:  Aug 10, 2022
Location: 

Scottsdale, Arizona, US

Department:  R&D
Description: 

 

 

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.

 

Job Summary:

In this role, you will be leading the technical activities of a development project for a multi-disciplinary medical device. As such, you will collaborate with local and global functional groups, stakeholders and management to deliver project goals and meet project milestones.

 

Essential Duties and Responsibilities:

 

  • Manage and lead the technical activities of a project and examine solutions based on functionality, quality and cost.
  • Implement Systems Engineering best practices for methodology, attend Systems Engineering training, and conduct necessary training for R&D staff as methodology is established.
  • Manage and lead the overall project interfaces between different R&D disciplines e.g. mechanical, HW, SW, lab, V&V and engineering etc. as applicable.
  • Manage the interface between different global West locations to assure product development according to customer needs, quality requirements and business priorities.
  • Key point of contact for technical product related interactions and discussions. Provide technical expertise and communication.
  • Responsible for global collaboration with other West functional groups (R&D, Regulatory, Quality, Operations, etc.) and customers during the product development process as well as throughout customer acquisition and adoption.
  • Plan and manage the development phases according to Product Development procedure
  • Build and maintain the Design History File (DHF), Initiate, perform and approve design reviews as part of the R&D plans.
  • Mentor and guide younger system engineers.
  • Provides a “Customer Service” attitude when interacting with internal and external customers while accomplishing work, production, and achieving quality standards.
  • Oversee risk management activities using tools such as FMEA and risk summary reports.
  • Responsible for assuring all design control process and documents follow the West QMS
  • Keep manager advised of all work status, workload, problems, and progress as related to work assignments.
  • Ensure development activities are following QMS, OSHA, local, state and federal environmental regulations.
  • Serve as a customer interface during new product adoption phase and support customer specific product variants as required
  • Improve processes and procedures to develop high quality products at a minimum cost.
  • Exhibits regular, reliable, punctual and predictable attendance.
  • Performs other duties as assigned based on business needs

 

Basic Qualifications: 

  • At least 5 years of experience in design control in the medical industry.
  • Education: Bachelor's in Mechanical, Biomedical, Material Science, or related Engineering field.

 

Preferred Knowledge, languages, Skills and Abilities:

  • Proven experience in risk management.
  • Background in R&D of Combination product.
  • Background in R&D of electromechanical medical device.
  • Familiarity with ISO-11608, IEC-60601, IEC-62304, ISO-14971 is an advantage
  • Skills: Team player, excellent communication skills, responsible, creative, organized, able to work in a dynamic environment

 

 

Travel Requirements:

  • Must be able to travel up to 10-20 % of the time

 

Physical & Mental Requirements:

  • Must be able to perform job duties as required with limited physical demands
  • Must be able to express or exchange ideas with employees as well as exernal stakeholders; Must be able to understand direction and adhere to established procedure

 

Competencies/Authorities

  • Non-US only where required for certain levels

 

 

 

 

 

 

 

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 Apply.Accommodation@westpharma.com.  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.

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