Job Summary:
In this role, you will manage multiple drug delivery development and sustainment teams; 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 multiple concurrent platform and customer product development programs with high resource requirements, risk, and/or complexity through all stages of the product development lifecycle.
- Ensure products and product platforms remain in compliance with all quality procedures, regulatory requirements, and industry standards.
- Develop and drive team to maintain and improve on key performance indicators including schedule adherence, complaint and non-conformance reduction, and on target to budgeted spend.
- Develop business cases for new products and product platforms.
- Develop and drive platform product development and sustainment strategy including product and process improvement roadmaps and identification of key capabilities needed for scale and growth.
- Participate in industry forums and standards committees as a West representative.
- Select, develop, and manage technical team ranging from early career to senior manager level to meet current and future needs.
- Build and maintain strong relationships with customers, business partners, functional leaders, and other senior level executives.
- Review technical team deliverables including change control plans, project schedules, design controls, and communication for quality, accuracy, and technical soundness.
- Performs other duties as assigned based on business needs.
- Conform with and abide 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. Master's degree in Business Administration or Engineering preferred.
- Minimum 10 years of experience in engineering capacity with 3 years in a leadership role.
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.
- 5+ years of medical device and/or drug delivery system product development experience.
- 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.