Sr. R&D Systems Engineer
Company: West Pharmaceutical Services
Posted on: November 16, 2020
Sr. R&D Systems Engineer
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
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 $1.84B in 2019. 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 with
Without Borders team member-led giving program.
POSITION SUMMARY: The Sr. R&D Systems Engineer will support
design and development activities of medical devices for West
proprietary products under development at the West Scottsdale
Arizona R&D site. This role has frequent interaction with
R&D Engineering, Product Sustainment Engineering, Quality,
Marketing, Regulatory Affairs and other key functions to achieve
The individual will bring excellent analytical, engineering, and
organizational talent to the execution of development projects at
West. PRIMARY DUTIES AND RESPONSIBILITIES: List primary duties and
responsibilities of the job, in order of importance and with
percentage of time spent on each duty / responsibility. If this is
a management level position, include supervisory
- Lead, implement and execute system engineering tools and
processes within the R&D group.
- Lead design control process of combination products throughout
product life cycle in accordance with relevant standards and FDA
- Participate in cross-functional teams for defining system
design and performance requirements specifications while applying
in-depth knowledge of design control of combination
- 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.
- Oversee and document design inputs and linkage between the
marketing requirements, standards review, risk management, user
requirements and technical requirements.
- Oversee and execute the documentation of design outputs and
show traceability to design inputs with trace matrix (Product
- Responsible for assuring all design control process and
documents follow the West QMS.
- Implement Systems Engineering best practices for methodology,
attend Systems Engineering training, and conduct necessary training
for R&D staff as methodology is established.
- Lead engineering and general design review as required.
- Collaborate with Sustaining Engineering, New Product
Introduction, and Quality to facilitate change, and resolve new or
existing product requirements issues.
- 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.
- Improve processes and procedures to develop high quality
products at a minimum cost.
- Exhibits regular, reliable, punctual and predictable
- Performs other duties as assigned based on business needs.
REQUIRED QUALIFICATIONS: List required education level and/or
equivalent experience, number of direct reports and any required
skills or certifications, consistent with West's leveling
- At least 3-5 years of experience in design control in the
- Proven experience in risk management.
- Education: Bachelor's in Mechanical, Biomedical, Material
Science, or related Engineering field.
- Must have excellent communication skills.
- Must have interpersonal skills.
PREFERRED QUALIFICATIONS: List any preferred education, skills,
- 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
PHYSICAL & TRAVEL REQUIREMENTS: List type of work environment
(office, home, etc---), % of travel required or any other relevant
- Must be able to perform job duties as required with limited
- 10-20% travel
The job description reflects the general details considered
necessary to describe the principal functions of the job identified
and shall not necessarily be construed as a detailed description of
all of the work requirements that may be inherent in the job.
West Pharmaceutical Services is an Equal Opportunity Employer
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 disability or special need that requires
accommodation, please send an email to email@example.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.
Keywords: West Pharmaceutical Services, Scottsdale , Sr. R&D Systems Engineer, Other , Scottsdale, Arizona
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