Principal Engineer, R&D, Verification

Who We Are:

 

At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?  

 

There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.  

 

We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.  

Job Summary:

The Principal Engineer, R&D, Verification, will work under the direction of the Verification Manager and will be responsible for managing all Verification activities in SDC for various development projects within SmartDose 10mL platform. The Principal Engineer will manage several key customer design verification activities and will lead the verification team in SDC as part of a global team of multi-site verification engineers and will work closely with the System Engineering manager, Lab manager and other R&D functional managers in order to meet the group goals and achieve business deliverables. The Principal Engineer will approve Verification Master Plans, Verification protocols and reports and can write and update related procedures. This role will bring excellent analytical, engineering, and organizational talent to the execution of development projects at West. 

 

Essential Duties and Responsibilities:

• Leading a team of design verification engineers within SDC.
• Manage and lead the verification activities and examine solutions based on functionality, quality and cost.
• Leading R&D and Verification activities including performing data analysis and write and/or review and/or approve technical documents such us verification plans, protocols, and reports.
• Offers strong leadership to the development team in leading the effort to execute R&D and verification testing activities for a product.
• Works with the Verification Manager and Project Manager to assure adherence to the development schedule.  Participates in the development of project scope, timeline, savings and cost estimations.
• Creates presentations and presents technical data to management and/or customer to drive project decisions and attain approvals.
• Recognizes inefficiencies and takes initiative to improve processes and implement procedures to streamline workflows and increase effectiveness. 
• Key point of contact for technical verification related interactions and discussions. Provide technical expertise and communication within that field.
• Collaboration with global internal functional groups including R&D, Quality, Regulatory Affairs and other key functions, and customers to achieve key business goals and deliverables.
• Creates necessary documentation in support of assigned activities in compliance with West QMS.
• Participated in design planning, risk assessment, design inputs definitions, design reviews, preparation of technical reports and design documentation.
• Participate in or lead root cause investigations to solve standard problems by analyzing possible solutions using experience, judgement and precedents.
• Improve design verification processes to develop high quality products at a minimalize cost
• Performs other duties as assigned based on business needs.

 

Basic Qualifications: 

• Education: B.Sc. in Bio-Medical Engineering or other related engineering discipline. Advanced degree in related discipline – an advantage
• Experience: Minimum 8 years of related work experience

 

Preferred Knowledge, Skills and Abilities:

• Able to be aware of all relevant standard operating procedures as per Company policy as they are related to the position covered by this Job Description
• Support and contribute to 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.
• Strong leadership qualities and should be able to provide training or mentorship to employees.
• Team building - recruiting and developing talent to meet the needs of the business, managing