Bachelor's degree in Mechanical Engineering or equivalent.
3+ years of relevant engineering experience, preferably in medical devices.
General understanding of FDA regulations and ISO 13485 standards.
Familiarity with Good Manufacturing Practices.
Experience with CAD software like SolidWorks or Creo preferred.
Responsibilities
Support sustaining engineering activities for medical device products.
Investigate product complaints and manufacturing nonconformances.
Design and implement engineering changes through change control processes.
Prepare and maintain engineering documentation including drawings and specifications.
Conduct design verification and validation testing for product changes.
Support cost reduction projects and component obsolescence issues.
Participate in root cause investigations and implement corrective actions.
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.
Health and Dependent Care Flexible Spending Accounts.
Commuter Benefits.
Parental and Caregiver Leave.
Tuition Reimbursement.
Full Job Description
Job Overview
The Product Sustaining Engineer II is responsible 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 under general supervision and collaborates with cross-functional teams to ensure product quality, regulatory compliance, reliability, and continuity of supply.
Job Responsibilities and Essential Duties
Support sustaining engineering activities for 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.
Minimum Requirements
Bachelor of Science degree (or equivalent), preferably in Mechanical Engineering.
Minimum 3+ years of progressive and relevant engineering experience, preferably in the medical device or other regulated industry. Advanced degree considered 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 work effectively within cross-functional teams.
Ability to manage multiple priorities while meeting project deadlines.
Salary range: $100k - $105k, 8% STIP
#LI-LG1 #LI-Hybrid
Benefits at Getinge:
At Getinge, we offer a comprehensive benefits package, which includes:
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
About Atrium Medical
Atrium Medical is a medical device company that develops and manufactures products for cardiovascular, surgical, and other medical applications. The company's products include vascular grafts, endovascular stent grafts, and other devices used in cardiac and thoracic surgery. Atrium Medical was founded in 1981 and has been a subsidiary of Getinge AB since 2011.
