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
In this role, you will support design and development activities within West's 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 goals, work independently only with strategic guidance in the most complex situations, interpret internal and external business issues and unmet needs, and take a broad perspective to define/plan/lead/develop solutions. You may collaborate with local and global functional groups, stakeholders, and management to deliver project goals and meet project milestones.
Essential Duties and ResponsibilitiesPlan and execute projects through all phases with a focus on design and qualification through verification and validation phases.Facilitate and lead the generation of requirements documentation, risk management documentation (e.g., user and product FMEA) in support of R&D projects.Create and edit product design models/drawings.Write engineering test protocols, reports, and work instructions. Plan, execute, and analyze design of experiments (DOE).Lead technical and design reviews.Drive innovation and process efficiency of integrated systems by applying innovative and logical risk-based approach to product development challenges with the capacity for original thinking.Apply engineering principles for design/analysis of complex technical problems and develop solutions using sound principles, and utilizing experimental, computational, and analytical methods. Examine solutions based on functionality, quality and cost.Write, implement, and leads bench studies, tolerance stack up analysis, design verification, validation, materials specifications, and component specifications.Generate, record and analyze data, and present results to peers and business leadership.Point of contact for technical product related discussions with the team. May provide technical expertise and communication for internal and external partners.Integrate planning activities between West and development/manufacturing partners, and work closely with Procurement to identify and qualify vendors ensuring appropriate components are procured and delivered as needed throughout the phased development process.May characterize system and/or sub-system inputs, outputs and functionality, utilize analytical skills and develop simulation tools to define appropriate product specifications, and system reliability.May implement best practices for methodology, and attend and conduct necessary training for staff as methodology is established. Mentor and guide system engineers.
Additional ResponsibilitiesLeading new product ideation activities, concept development and evaluation.Applying design for manufacture principles to support high-volume manufacturing processes.
EducationBachelor's Degree in Mechanical or Biomedical Engineering required; or equivalent experienceMaster's Degree Mechanical or Biomedical Engineering preferred; or equivalent experience
Work ExperienceMinimum 5 years experience in the medical device or combination product industry requiredExperience in high-volume, automated manufacturing processes, and glass forming preferredExperience in Human Factors for Medical Devices preferredExpertise with test method development, validation strategy, and execution required
Preferred Knowledge, Skills and AbilitiesWorking knowledge of ISO 13485, 2017/745 (MDR) and 21 CFR Part 820 is essentialExpertise with risk management, design verification and validation strategy development and executionExpertise in medical device design control and change managementExperience with combination products requirements and regulationProficiency in CAD solid modeling/draftingProficiency in solid mechanics/mechanics of materialsProficiency in statistical methods/toolsProficiency in project managementKnowledge 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, MDRAbility to comply with the company's safety and quality policies at all times
Travel Requirements
20%: Up to 52 business days per year
Physical Requirements
Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.
Additional RequirementsAble to routinely use standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Position operates in a professional office environment. 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 direction and adhere to proceduresOrganizational skills will enable planning, prioritization and achievement of goals especially of importance for the successful execution of related activitiesRead and interpret data, information and documentsMust maintain the ability to work well with others in a variety of situationsMust be able to multi-task, work under time constraints, problem solve, and prioritizeAbility to make independent and sound judgmentsObserve and interpret situations, analyze and solve problemsAble to perform Research and Development lab activities Must be able to deal with ambiguity, use timely decision making, understand sensitivity for IP protection, deliver concise presentations to high-profile conferences, understand strategic direction, make contributions to strategy formation, be reliable and have predictable attendance
What We Offer
This is a hybrid position requiring the team member to be onsite a minimum of 3 days per week
ShiftDay shift: 8am - 5pmHybrid role: 2 days wfh and 3 days on-siteWest 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. #LI-AS1