Title:  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 a diverse team.
• Excellent technical writing skills and substantial experience writing test plans, protocols, and reports.
• Ability to lead customer or internal stakeholder discussion, accommodating shared information to match the applicable audience.
• Ability to manage multiple priorities with high flexibility and rapid response time.
• Ability to build strategic verification planning for programs.
• Demonstrated ability to exercise independent judgment in making decisions and resolving complex problems by taking a new perspective using existing solutions, exercises judgment based on the analysis of multiple sources of information.
• Ability to reach resolutions as the professional lead and expert of design verification in professional discussions with cross-functional team. Act as the verification resource and focal point of contact for other team members.
• Decisions made with in-depth knowledge and experience within the design verification discipline, understanding and interpretation of procedures, policies and business practices to achieve results.
• Excellent “customer service”, communication, and interpersonal skills.
• This position requires a creative and highly organized person who is articulate and personable, rapidly establishes rapport with diverse personalities, responds to people’s needs, and demonstrates initiative and commitment to quality in all tasks.
• Proficient in MS Office suite including PowerPoint, Word, Excel and Outlook.
• Expertise in Design Controls, Risk Management, Statistics, Engineering Principles, Test Method Development, Test Method Validation (Gage R&R), and Design Verification.
• Knowledge of ISO 13485 – Quality Management Systems for Medical Devices.
• Knowledge of 21 CFR 820.30 - Design Controls.
• Knowledge of ISO 10993-1: Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process - a plus
• Knowledge of ISO 11608 series: Needle-based injection systems for medical use – a plus
• Knowledge of IEC 60601-1 series: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance – a plus.
• Knowledge of Risk management (ISO 14971) - an advantage.
• Project Management - an advantage.

Travel Requirements:

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

Physical and Mental Requirements:

• Sedentary - exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to life, carry, push, pull, or otherwise move objects, including the human body.  Sedentary work involves sitting most of the time.  Jobs are sedentary if walking and standing are required only occasionally, and all other sedentary criteria are met
• Diligent with the ability to handle multiple tasks and withstand tight timeline.
• Taking prompt action to accomplish objectives; taking action to achieve goals beyond what is required; being proactive.

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West embraces diversity and equality of opportunity. We foster an environment where all individuals are safe, treated fairly, valued and respected. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, disability status or other applicable legally protected characteristics. Where permitted by law, employment with West Pharmaceutical Services, Inc. or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of post-offer background screening and/or drug screening.