Sr. Engineer, Quality Product Design - Wayne, NJ

Job Overview

The Sr. Engineer, Quality Product Design is responsible for ensuring the product meets the highest quality standards throughout the development and lifecycle management process. 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.

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.
• Serve as SME for the design and development process.
• Integrate with the R&D team to ensure quality and compliance in product development.
• Perform and support risk analysis and management through implementation of mitigation strategies.
• Manage risk management files throughout the product lifecycle.
• Develop and implement 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.
• Ensure these components as part of Design History Files are developed, controlled, and maintained.
• Support design reviews, verification, and validation activities.
• Participate in design reviews, test method validations, cross functional teams, risk assessments, code review, and unit test inspections.
• Support 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

• Bachelor’s degree in engineering, Computer Science, Science, or other related field is required.
• AQS Certified Quality Engineer, ASQ Certified Reliability Engineer, and Six Sigma Green Belt certification is desireable.
• Minimum of 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 testing, design controls, development, and/or 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 ISO 14971 and ISO 13485.
• Experience driving risk management discussions, particularly as it relates to cascading identified product issues/hazards into potential user harms.
• Project management and leadership experience is desirable.
• 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.
• Proficiency using Microsoft Office Products such as Word, Excel, or equivalent software applications.

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.

Benefits

• Health, Dental, and Vision insurance benefits
• 401k plan with company match
• Paid Time Off
• Wellness initiative & Health Assistance Resources
• Life Insurance
• Short and Long Term Disability Benefits
• Flexible Spending Accounts
• Commute Benefits
• Parental and Caregiver Leave
• Tuition Reimbursement

Contact Information

Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law. Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.