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Sr. Quality Product Engineer

1 month ago

Wayne, United States Getinge Full time
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 Sr. Quality Product Engineer 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.
  • Supports design reviews, verification, and validation activities. Participate in design reviews, test readiness reviews, cross functional teams, risk assessments, code review, and unit test inspections.
  • Review, approve and participate in qualification of acquired software and software tools. Review and approve resolution of released software issues. Review change notices (CNs) & Protocols/Protocol Results/RFDs for software-related changes
  • Support software issue investigations, risk assessments, and associated CAPA activities
  • Support the Health and Hazard Evaluation process by gathering required data and performing in-depth analysis prior to sharing the information with the Field Action Committee. Also supports regulatory submissions.
  • Perform periodic audits of projects against SOP's and process.
  • Prepare, support, and ensure the readiness for any potential internal and/or external audits and inspections.
  • Work special projects as assigned.
Required Knowledge, Skills and Abilities
  • A bachelor's degree in computer science, engineering, Science, or other related field is required. ASQ Certified Quality Engineer, ASQ Certified Reliability Engineer, ASQ Certified Software Quality Engineer, and Six Sigma Green Belt certification is preferred.
  • Minimum of five (5) years of related experience that includes New Product Development and/or Sustaining Engineering
  • Strong analytical and problem-solving skills. Proficiency in quality tools and methodologies (e.g., Six Sigma, FMEA).
  • Experience in Quality Assurance with a focus on software testing, design controls, software development, and/or software verification & validation
  • Experience in the medical device industry or other highly regulated field (biotech, pharma, aerospace/aviation, automotive)
  • Knowledgeable and demonstrated application of standards such as IEC62304, FDA's General Principles of Software Validation, ISO 14971, and IEC60601-1.
  • Experience driving risk management discussions, particularly as it relates to cascading identified product issues/hazards into potential user harms.
  • Experience in Medical Device Cybersecurity is preferred.
  • Project management and leadership experience is desirable.
  • Knowledge of Microsoft Office Products such as Word, Excel, or equivalent software applications.
  • Excellent communication and interpersonal skills. Ability to work effectively in a cross-functional team environment.
  • Ability to review and understand technical standards and their requirements for products

Salary Range: $90k-$110k

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About us

With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.

Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.