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 business deliverables.

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 responsibilities.

Product Development

• 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 guidance.
• Participate in cross-functional teams for defining system design and performance requirements specifications while applying in-depth knowledge of design control of combination products.
• 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 Requirement Matrix). 
• 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.

Product Sustainment  

• Collaborate with Sustaining Engineering, New Product Introduction, and Quality to facilitate change, and resolve new or existing product requirements issues.

General

• 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 attendance.
• 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 guidelines.

• At least 3-5 years of experience in design control in the medical industry.
• 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, and/or experience.

• 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

PHYSICAL & TRAVEL REQUIREMENTS:  List type of work environment (office, home, etc...), % of travel required or any other relevant working conditions.

• Must be able to perform job duties as required with limited physical demands
• 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