Title:  Principal 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 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:

The R&D team within West’s Glass Systems business is seeking a Principal R&D Engineer.  In this role, you will lead design & development activities within Wests Product Development Process demonstrating leadership and strategic thinking within a goal-oriented organization. The incumbent will:

1. Demonstrate accountability for the successful and timely achievement of goals
2. Work independently only with strategic guidance in the most complex situations
3. Interpret internal and external business issues and unmet needs and take a broad perspective to define/plan/lead/develop solutions

Essential Duties and Responsibilities:

• Plan and execute projects through all phases with a focus on design and qualification through verification and validation
• Create, edit, Product models/drawings
• Write engineering test protocols, reports, and work instructions
• Lead technical reviews and design reviews
• Apply engineering principles for design/analysis of complex technical problems
• Drive innovation and process efficiency of glass systems
• Develop technical solutions to complex problems using sound engineering principles, utilizing experimental, computational, and analytical methods
• Apply innovative & logical risk-based approach to product development challenges with the capacity for original thinking. Develop robust test methods, design test fixtures, and execute measurement system analysis
• Plan, execute, and analyze design of experiments (DOE)
• Write, implement and lead bench studies, tolerance stack-up analysis, design verification, validation, materials specifications, and component specifications
• Generate, record and analyzes data, present results to peers and business leadership

• Integrate planning activities between West and development/manufacturing partners
• Work closely with Procurement to identify and qualify vendors ensuring appropriate components are procured and delivered as needed throughout the phased development process
• Conform with and abide by all regulations, policies, work procedures, instructions, and all safety rules
• Other duties as assigned

Basic Qualifications: 

• Minimum B.S. in Mechanical or Biomedical Engineering, M.S. preferred, or equivalent experience
• 8 - 10 years of experience in the medical device or Combination Product industry

Preferred Knowledge, Skills and Abilities:

• Expertise in medical device design control and change management
• Expertise in Risk Management, Design Verification & Validation strategy development, and execution
• Expertise with test method development, validation strategy, and execution
• Strong interpersonal and decision-making skills and the ability to effectively manage change and uncertainty
• Knowledge of applicable ISO, and USP standards for drug delivery
• Knowledge of applicable health authority regulations including FDA, MDR
• Proficiency in Solid Modeling/Drafting
• Proficiency in solid mechanics/mechanics of materials
• Proficiency in statistical methods/tools
• Proficiency in project management
• Experience with Combination Products requirements and regulation
• Experience in high-volume, automated manufacturing processes, and glass forming
• Experience in Human Factors for Medical Devices
• Knowledge of Six Sigma (DMAIC) practices, and Design for Six Sigma (DFSS) methodologies
• Ability to lead and teach others to assess project/program needs, formulate strategies, build support, and execute initiatives
• Strong interpersonal and decision-making skills and the ability to effectively manage change and uncertainty
• Knowledge of applicable ISO, and USP standards for drug delivery
• Knowledge of applicable health authority regulations including FDA, MDR
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
• Able to comply with the company’s safety and quality policy at all times

Travel Requirements:

• Must be able to travel up to 30% of the time, including internationally

Physical & 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.
• Normal activities in R&D lab work and ability to work in an office. May need to stand or sit for extended periods of time
• Dealing with ambiguity
• Reliable and predictable attendance
• Timely decision making
• Sensitivity for IP protection
• Concise presentation at high profile conferences
• Understanding strategic direction and making contribution to strategy formation
• Ability to hear, speak, and understand conversation in English in a normal tone of voice
• Must maintain the ability to work well with others in a variety of situations
• Must be able to multi-task, work under time constraints, problem solve, and prioritize
• Must be able to communicate effectively, speak in front of groups, express & exchange ideas and understand direction
• Maintain the ability to work well with others in a variety of situations
• Able to learn and apply new information or new skills
• Communication, quick decision making, interpreting data, reading, or writing - must be able to express or exchange ideas with team members
• Must be able to understand direction and adhere to established procedures
• Read and interpret data, information and documents
• Ability to make independent and sound judgments
• Demonstrates enthusiasm, takes accountability and drives for results

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.