Job ID R-302657
As directed by the Quality Manager, the Staff Quality Engineer I is accountable for supporting new product development and product maintenance through the application of Quality engineering skills for medical devices. This person will handle projects and tasks, from product inception through product launch and maintenance and play an active role in the processes to ensure products meet quality standards consistent with both Corporate and unit policies, while meeting all design control and other regulatory requirements.
- Extensive application of technical principles, theories, concepts and quality sciences, tools and systems with measureable / confirmed results.
- Track record of root cause determination and effective corrective / preventive action implementation.
- Provides training for product development teams and continuous improvement teams on best practices.
- Conducts audits as member of a quality system audit team (e.g. SME, etc.)
- Writes and leads risk management activities including risk management reports and risk analyses.
Scope of Responsibility
- Guides the successful completion of major programs and may function in a project leadership role.
- Provides management with review opportunities at key points and upon completion
- Ensures quality conduct of projects, including design, data summary and interpretation, report and manuscript preparation and review adherence to applicable regulations
- Decisions, recommendations and results further the achievement of goals critical to organizational objectives
- Implements and communicates the strategic and technical direction for the product/project team
- Identifies any issues that may delay product or project and recommends appropriate action to be taken
Position Specific Overview
- Reliability: Understand basic ReliabilityEngineering practices.Includes familiarity with: Reliability Growth Testing (RDT), Reliability Demonstration Testing (RDT), Life Test, HALT, HASS, Idealized Growth Curve, etc.
- Software: Understand the software development (SW) and testing life cycle as defined by ISO 62304.Experience supporting SW-related R&D design change efforts through development and/or testing.Understanding of SW issues tracking, automation, issues tracking, risk assessment and bug containment.
- Compliance: Ability to support R&D efforts specifically aimed at compliance with domestic or international (e.g. MDR, IEC 60601, 3rd Edition, ISO 13485) requirements.Experience supporting or navigating such projects.Interacting with governing bodies and test houses.
- Injection Molding: Experience with mold tooling and molding processes at minimum.Scientific Molding, polymer science, injection molding, blow molding, liquid injection molding (LIM), metal injection molding (MIM), extrusion, process optimization.
- Bachelors Degree in Engineeringrequired, electrical or mechanicalpreferred
- Minimum 8-10 years of quality engineeringexperience
Embedded software validation experiencepreferred
Capital Equipment validation preferred
Experience with Risk Management Preferred
Ability to act as Change Agent
Experience working with cross-functional teams and remote teams
Prefer infusion pump experience or drug delivery experience (regulated FDA industry)
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status