Sr. Engineer, Product Sustaining - Wayne, NJ

Getinge; Wayne (NJ); Presencial; USD 117.000 - 125.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health benefits

401k match

Paid time off

Tuition reimbursement

Descripción de la vacante

Getinge is seeking a Product Sustaining Senior Engineer in the United States to lead sustaining engineering activities for medical device products. You will investigate complaints, design and implement changes, maintain technical documentation, and ensure compliance with FDA QSR and ISO 13485 standards.

The role requires 5+ years in a regulated environment, strong CAD and problem-solving skills, and the ability to lead cross-functional teams with minimal supervision.

Formación

• Bachelor degree in Mechanical Engineering or equivalent.
• 5+ years in medical device or regulated industry preferred.
• Experience with design controls and change management advantageous.

Responsabilidades

• Technical lead for sustaining engineering activities on released medical device products.
• Investigate complaints, nonconformances, field issues, and failures.
• Design and implement engineering changes via change control processes.
• Prepare and maintain engineering docs, specs, tests, and reports.
• Perform analyses including tolerance stack-ups and stress calculations.
• Conduct design verification and validation testing for product changes.
• Support cost reduction projects and obsolescence issues.
• Lead root cause investigations and CAPA implementations.
• Ensure compliance with FDA QSR, ISO 13485, and other standards.
• Provide technical support to Quality, Operations, Service, Regulatory Affairs, and Customer Support.
• Act as engineering lead on projects and mentor juniors.

Conocimientos

Mechanical engineering knowledge

GD&T

CAD software (SolidWorks/Creo)

Regulatory knowledge (FDA/ISO)

Problem solving

Cross-functional leadership

Educación

Bachelor of Science in Mechanical Engineering

Herramientas

SolidWorks/Creo CAD

Microsoft Office

Descripción del empleo

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.

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.

Job Overview

The Product Sustaining Sr. Engineer is responsible for technical leadership and engineering support for sustaining engineering activities including product improvements, design changes, cost reduction initiatives, component obsolescence management, manufacturing support, complaint investigations, and corrective and preventive actions (CAPA). This position works with minimal supervision and collaborates with cross-functional teams to ensure product quality, regulatory compliance, reliability, and continuity of supply.

Job Responsibilities And Essential Duties

• Technical lead for sustaining engineering activities supporting released medical device products.
• Investigate product complaints, manufacturing nonconformances, field issues, and returned product failures.
• Design and implement engineering changes through established change control processes.
• Prepare and maintain engineering documentation including drawings, specifications, test protocols, reports, and technical justifications.
• Perform engineering analyses including tolerance stack-up analyses, stress calculations, material selection, and failure analysis.
• Conduct design verification and validation testing to support product changes.
• Support cost reduction projects, component and material changes, supplier changes, and product obsolescence issues.
• Participate in root cause investigations and implementation of corrective and preventive actions (CAPA).
• Ensure compliance with FDA Quality System Regulations, ISO 13485 requirements, and applicable international regulatory standards.
• Provide technical support to Quality, Operations, Service, Regulatory Affairs, and Customer Support organizations.
• Act as engineering lead on projects.
• Mentor junior engineers and provide technical guidance across sustaining engineering projects.

Minimum Requirements

• Bachelor of Science degree (or equivalent), preferably in Mechanical Engineering.
• Minimum 5 years progressive and relevant engineering experience, preferably in the medical device or other regulated industry or advanced degree in leu of experience.
• General understanding of Good Manufacturing Practices, FDA regulations, and ISO requirements.

Required Knowledge, Skills And Abilities

• Understanding of mechanical engineering principles, materials, manufacturing processes, and product development methodologies.
• Knowledge of engineering drawings, GD&T, tolerance analysis, and material properties.
• Understanding design of injection molded plastic, casting, sheet metal, machined components, and pneumatics preferred.
• Experience using CAD software such as SolidWorks, Creo, or equivalent preferred.
• Understanding of Design Control processes and engineering change management.
• Working knowledge of root cause analysis methodologies and problem-solving tools.
• Basic understanding of FDA regulations, ISO 13485, and other applicable medical device regulations preferred.
• Strong analytical and problem-solving skills.
• Self-motivated with the ability to accomplish project goals with minimal supervision.
• Effective verbal and written communication skills.
• Proficiency in Microsoft Office applications including Excel, Word, and PowerPoint.
• Ability to effectively lead cross-functional teams and influence without direct authority.
• Ability to manage multiple projects and priorities in a fast-paced environment.

Salary range: $117k - $125k; 10% STIP

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 At Getinge

• 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
• Health and Dependent Care Flexible Spending Accounts
• Commuter Benefits
• Parental and Caregiver Leave
• Tuition Reimbursement

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.