The Senior QE will support new product development and product maintenance through the application of Quality engineering skills. The ability to handle multiple projects and tasks, from product inception through product launch and maintenance is essential. Perform an active role in the processes to ensure products meet quality standards consistent with both Corporate and division policies while meeting all design control and other regulatory requirements.
Represents the Quality Function on project teams for both new product development and existing products. Contributes content to Design History Files. Be the Senior Quality Engineer
- Design Assurance Quality Engineer on project core teams (PM, R&D, RA, Clinical, Marketing, Systems Engineering, Software Engineering) for design change projects.
- Responsible for product quality, DHF documentation, compliance, patient safety, customer satisfaction. Adaptively apply working knowledge of quality engineering concepts and test methods within the product lifecycle.
- Generate test protocols based on specification requirements; proper selection of appropriate test methods to develop test protocols and execute them.
- Perform statistical analysis of results.
- Review quality objectives and goals that have been identified and ensure they are sufficiently defined in specifications, procedures, and testing.
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 Reliability Engineering 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 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) Experience supporting or navigating such projects. Interacting with governing bodies and test houses.
- Injection Molding: Experience with mold tooling and molding processes at a minimum. Scientific Molding, polymer science, injection molding, blow molding, liquid injection molding (LIM), metal injection molding (MIM), extrusion, process optimization.
- Minimum Bachelor’s Degree in Engineering required or related discipline
- Minimum 5-7 years of medical device quality engineering experience
- Expertise in design assurance including design controls
- Embedded software validation experience preferred
- 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)