Product Development Process Improvement Specialist
Maximizes R&D effectiveness by leading and supporting R&D process improvement activities and by driving a culture of change and operational improvement within R&D.
- Identifies R&D process improvement initiatives that either streamline, create consistency, reduce cost, and/or increase efficiency by collaborating with cross-functional teams to review key performance indicators, project trends, project data, project issues, quality observations and issues, product development issues, strategy, and organizational needs.
- Drives continuous improvement initiatives by building project proposals and influencing stakeholders to gain approval for those proposals.
- Develops, reviews, and implements project plans for R&D development process improvement initiatives (including scope, budgets, schedules, and resources).
- Develops and analyzes key performance indicators and measures; establishes baselines for performance measures; and monitors process improvement initiatives against baselines for improvement tracking.
- Markets and reports on R&D improvement initiative results. Ensures consistency in reporting with key performance measures through training, guidance, or other mechanisms.
- Supports regulatory compliance and internal audit activities of processes in R&D. Ensures preparedness and efficiency in delivery of regulatory compliance audit information for product development processes.
- Bachelors degree in a related discipline
- 10 years - 10 + years of relevant experience with 5+ years of experience within an FDA regulated industry.
- Bachelors in Engineering or science discipline preferred
- Black Belt in either Six Sigma or Design for Six Sigma preferred.
- Project management training preferred.
Knowledge, Skills, and Abilities:
- Expert knowledge of product development processes and understanding of how they are applied to Medical Devices per FDA 21 CFR Part 820 Subpart C and ISO 13485.
- Excellent communication skills, especially in the areas of negotiation, influencing, and networking
- Ability to effectively communicate with all levels of the organization by establishing credibility and building rapport.
- Excellent problem solving, analytical, and decision making skills.
- Driven, self-starter with excellent planning and organizational skills and a strong attention to detail