Quality Engineer, Medical Devices, New Product Development, ISO 13485, 14971, 62304, Software, Hardware, SDLC, Design Controls, Risk Management
Our Staff Quality Engineer 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 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 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 Engineering required, electrical or mechanical preferred
- Minimum 8-10 years of quality engineering experience
- 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)
Sthree US is acting as an Employment Agency in relation to this vacancy.