Senior Engineer, Process Validation

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

Lead equipment and process qualification initiatives for existing and new product lines.

Job Responsibilities and Essential Duties :

• Responsible for Process Validation.
• Responsible for processing ECO’s.
• Supports Production and Manufacturing operations.
• Responsible for manufacturing methods and their transfer into production.
• Engineering support, including but not limited to vendor contact and auditing specification.
• Responsible for Process Risk Management.
• Provide assistance for equipment design for producing medical devices and components as required.
• Responsible for manufacturing methods and their transfer into production.
• Work closely with Manufacturing and Manufacturing Engineering to support new processes and equipment that have been recently released into production.
• Modify and improve existing equipment. Improve manufacturing efficiency, production yeilds, product quality and consistency through equipment and design modifications and fabrications.
• Maintain compliance to Quality System and regulations for new processes and equipment.
• Assist in special projects as needed.
• Contribute to team effort by accomplishing related duties as requested.

Required Knowledge, Skills and Abilities:

• Problem solving / troubleshooting skills.
• Excellent communication skills.
• Able to work in a cross functional team environment.
• Computer skills including MS Office Suite (Word, Excel, etc.).
• Experience with introducing equipment and process qualification required.
• Experience with process control & statistical analysis techniques required.
• Experience in a medical device environment or other regulated industry is required.
• Experience with PLM software preferred.

Minimum Requirements:

• Bachelor’s Degree required (Engineering degree preferred)
• 5+ years medical device validation experience required (10+ preferred)

Environmental/Safety/Physical Work Conditions:

• Ensures environmental consciousness and safe practices are exhibited in decisions.
• Duties are performed in a combination of office and manufacturing environments.

The physical demands described here are a representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The salary range for this position is a minimum of $94,000 to a maximum of $118,000 annually + 5% bonus potential.

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:

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

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.