Description
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 manage a drug delivery devices product development team; providing platform and customer product development, failure investigation, and post-market design sustainment for our portfolio of handheld and wearable drug delivery systems.
Essential Duties And Responsibilities
- Lead technical team to define, drive, and manage changes to the product design history file.
- Lead product review and impact assessments to industry standards, customer contracts, and regulatory requirements.
- Provide support of product complaints and non-conformances to assess impact, determine root cause(s), and identify corrective and preventative actions.
- Understand product design history file contents and support customer and regulatory audits.
- Identify and evaluate opportunities, unmet needs, and requirements for new product / product line extension projects and/or product optimization development projects.
- Partner with senior leadership to establish, communicate, and drive platform product development and sustainment strategy including roadmaps and key capabilities.
- Identify and evaluate new tools and consulting services to support product and process development needs.
- Select, develop, and manage technical team ranging from early career to senior level to meet current and future needs.
- Interface with customers and external support services, e.g. suppliers and contract vendors, to facilitate the development and execution of assigned programs.
- Build, track, manage, and communicate project schedules to internal and external stakeholders to meet all deliverables on time.
- Review technical team deliverables including change control plans, project schedules, design controls, and communication for quality, accuracy, and technical soundness.
- Use sound engineering principles and critical thinking skills to make risk-based decisions and drive the completion of deliverables.
- Performs other duties as assigned based on business needs.
- Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
Basic Qualifications
- Bachelor's degree in Engineering, other technical related field, or equivalent experience
- Minimum 8 years of experience in engineering capacity
Preferred Knowledge, Skills And Abilities - Demonstrated ability to:
- Lead, prioritize, and complete multiple technical projects and daily tasks.
- Lead and mentor others.
- Facilitate and coach others through effective problem solving and decision making processes.
- Understand and communicate technical ideas and concepts with technical and non-technical audiences (written and verbal).
- Delegate and empower others while maintaining accountability to overall functional performance.
- Work well with others in a variety of situations.
- Background in development or sustainment of electromechanical products.
- Broad experience in product development from early feasibility through commercialization and into sustainment including design controls, statistics, test method development, gauge R&R, human factors engineering, design verification, and design validation.
- Knowledge of ISO 11608, IEC 60601, ISO 14971, ISO 10993, and other relevant standards for medical devices.
- Experience influencing business and technical teams to adopt alternative ideas and methods.
- Knowledge of lean product and manufacturing concepts including design for manufacturability.
- Proficiency in MS Office Suite, Minitab, and DevOps.
Travel Requirements
- Must be able to travel up to 10% of the time to domestic & international customers and West manufacturing locations as project requirements & business needs require.
Physical And Mental Requirements
- Work in an office/home office environment. At times required sit or stand for extended periods of time.
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.
