Engineer I, Production - Cardiac Surgery

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 primary responsibility for this Engineer I, Manufacturing Engineering position will be reviewing production documentation and addressing deficiencies found, performing equipment qualifications, continuous improvement initiatives, and tasks related to manufacturing sustainability. This position will report to the Manager, Manufacturing Engineering.

Job Responsibilities and Essential Duties

• Drive process improvements and support daily manufacturing operations to ensure safety, quality, and efficiency goals are met.
• Initiate and manage Engineering Changes to document product or process changes, ensuring timely and compliant implementation.
• Support validation activities by drafting and executing protocols (IQ/OQ/PQ) and compiling objective evidence to demonstrate process capability and control.
• Analyze manufacturing data to identify trends in yield, scrap, and downtime, and implement corrective actions in collaboration with cross-functional teams.
• Review and update controlled documentation, including manufacturing procedures, work instructions, and equipment records, to ensure compliance with current practices and regulatory requirements.
• Ensure adherence to Quality System Regulations (QSR), GMP, and ISO 13485 standards in all aspects of production support and documentation.
• Participate in complaint investigations and nonconformance resolution, contributing engineering input to root cause analysis and corrective actions.
• Support internal and external audits, including FDA and other regulatory bodies, by providing technical documentation and process knowledge.

• Initiate Design Changes and Change Notices to document changes being implemented.
• Write and execute validation protocols, to demonstrate acceptability of a proposed change. Compile and analyze protocol test data.
• Review procedures and determine whether they are being followed. Implement changes as needed. (Engineering specifications, change notices, manufacturing procedures, equipment registrations and other documentation).
• Comply with Quality System Procedures, Good Lab Practices, and Exposure Control Plan.
• Support efforts for complaint investigation compliance with the Food and Drug Administration (FDA), European Union Medical Device Directive (MDD), European Union Medical Device Reporting (EUMDR), Alternate Summary Report (ASR), and applicable regulations and regulatory governing standards.
• Ensure timely and accurate investigations of returned products to support effective complaint closures as required by Complaint Engineering group.
• Supports the FDA and other 3rd party audits as required by Complaint Engineering group.

Minimum Requirements

• B.S. Engineering degree, preferably in Biomedical, Manufacturing, or Mechanical Engineering or equivalent

Required Knowledge, Skills, and Abilities

• Strong technical and analytical ability, ingenuity. Detail oriented.
• Must be a good communicator, both verbal and written communication skills, with good interpersonal skills.
• Good organizational skills. Must be able to adhere to timelines.
• Computer skills including, but not limited to: Microsoft Windows, Word, Excel.
• Familiarity with statistical analysis.
• Project Management.

Salary range:$87K - $95K

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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.