Sr. Quality Product Engineer - Wayne, NJ

 

 

With a passion for life

 

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers.

Are you looking for an inspiring career? You just found it.

 

 

 

Getinge is a global company that designs and manufactures medical devices and life science equipment. We affect the environment in various ways during a products life cycle so we have a goal to be CO2 neutral by 2025 and we are engaged in achieving the Paris Agreement goal of limiting global warming to 1.5°C above pre-industrial levels.

 

We focus on the pride and passion we have in belonging to Getinge and how our employees can share a passion to be part of a company with the central purpose of saving lives. We are looking for individuals to join our team.

 

We currently have an open position for a Sr. Quality Product Engineer is part of the QE - Product Development team is responsible for ensuring the product software (embedded and featured) meet the highest quality standards throughout the development lifecycle. This role involves working closely with the cross-functional product engineering team to identify and mitigate risks, implement quality controls, and ensure compliance with industry regulations and standards. This position is also responsible to develop, improve and implement quality processes, conduct risk assessments, and ensure compliance to design controls requirements. The Quality Engineer II will also support continuous improvement initiatives and contribute to the development of quality assurance processes and documentation.

 

Job Responsibilities and Essential Duties

• Ensures assigned product development and/or design change initiatives are executed in accordance with Design Controls procedural requirements. Ensure compliance with ISO 13485, ISO 14971, FDA 21 CFR Part 820, EU MDD, EU MDR and other relevant regulations and standards.
• Ensure the safety of the software products developed by managing the software product life cycle activities to meet the quality system requirements.
• Ensure software products comply with relevant Software lifecycle management standards for medical devices (e.g., IEC 62304).
• Serves as Software SME for the design and development process.
• Integrate with the R&D team to ensure quality and compliance in the software development.
• Perform and support software risk analysis and management through implementation of mitigation strategies. Manage risk management files throughout the product lifecycle.
• Develop and implement software quality assurance plans, protocols, and standards.
• Support design verification and validation activities, including protocol development, execution, and report generation.
• Based on User Requirements provide input on design control documentation, ensuring that it meets quality and regulatory requirements. Ensures these components as part of Design History Files are developed, controlled, and maintained.