Reference #: 1027116701At 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 R&D team within West's Glass Systems business is seeking a Principal R&D Engineer. In this role you will lead design and development activities within Wests Product Development Process demonstrating leadership and strategic thinking within a goal-oriented organization. The incumbent will:

　　Demonstrate accountability for the successful and timely achievement of goalsWork independently only with strategic guidance in the most complex situationsInterpret 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 validationCreate and edit Product models/drawingsWrite engineering test protocols, reports, and work instructionsLead technical reviews and design reviewsApply engineering principles for design/analysis of complex technical problemsDrive innovation and process efficiency of glass systemsDevelop technical solutions to complex problems using sound engineering principles, utilizing experimental, computational, and analytical methodsApply innovative and 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 analysisPlan, execute, and analyze design of experiments (DOE)Write, implement and lead bench studies, tolerance stack up analysis, design verification, validation, materials specifications and component specificationsGenerate, record and analyze data, and presents results to peers and business leadershipIntegrates planning activities between West and development/manufacturing partnersWork closely with Procurement to identify and qualify vendors ensuring appropriate components are procured and delivered as needed throughout the phased development processOther duties as assignedBasic Qualifications - Education:Bachelor's degree in Mechanical or Biomedical Engineering or equivalent experienceBasic Qualifications - Work Experience:Minimum 8 years of experience in medical device or Combination Product industryExpertise in medical device design control and change managementExpertise with Risk Management, Design Verification & Validation strategy development and executionExpertise with test method development, validation strategy, and executionKnowledge of applicable ISO, and USP standards for drug deliveryKnowledge of applicable health authority regulations including FDA, MDRProficiency in Solid Modeling/DraftingProficiency in solid mechanics/mechanics of materialsProficiency in statistical methods/toolsProficiency in project management

　　Preferred Knowledge, Skills and Abilities:Master of Science degreeExperience with Combination Products requirements and regulationExperience n high-volume, automated manufacturing processes, and glass formingExperience in Human Factors for Medical DevicesKnowledge of Six Sigma (DMAIC) practices and Design for Six Sigma (DFSS) methodologiesAbility to lead and teach others to assess project/program needs, formulate strategies, build support, and execute initiativesStrong interpersonal and decision-making skills and the ability to effectively manage change and uncertaintyKnowledge of applicable ISO, and USP standards for drug deliveryKnowledge of applicable health authority regulations including FDA, MDRTravel Requirements:Must be able to travel up to 30% of the timePhysical Requirements:Job demand classification is 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.Additional Requirements:Able to routinely use standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Position operates in a professional office environment and/or R&D lab. May stand or sit for extended periods of timeMust be able to communicate effectively with written and oral skills, make quick decisions, interpret data, read and write, speak in front of groups, express and exchange ideas, understand strategic direction, adhere to procedures and make contributions to strategy formationWest 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 .  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.

　　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 protected].