Bachelor's degree in Mechanical Engineering or equivalent.
5+ years of relevant engineering experience in medical devices or regulated industries.
General understanding of FDA regulations and ISO 13485 standards.
Familiarity with mechanical engineering principles and manufacturing processes.
Experience with CAD software like SolidWorks or Creo.
Responsibilities
Lead sustaining engineering activities for released 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 engineering analyses such as tolerance stack-up and failure analysis.
Perform design verification and validation testing for product changes.
Support cost reduction initiatives and manage component obsolescence.
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 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
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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.
