Engineer II, Production (CAPA)

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

Supports the Manufacturing Engineering department needs with an emphasis on Corrective Action and Preventive Action Process (CAPA).

The primary responsibilities of the Manufacturing Engineer II (CAPA Process) position are:

• Lead and owns CAPAs in the areas of process and product improvements.
• Investigation and response to production issues or to customer complaints
• Ensure compliance to procedures for CAPA Systems, regulations of FDA, and other regulatory bodies.
• Develop and maintain production documentation such as procedures, routers, BOMs.

Job Responsibilities and Essential Duties

Primary:

• Serves as a CAPA Owner
• Supports Manufacturing Engineering, which includes ensuring that corrective and preventive actions are issued as required, properly investigated, documented, effective, and completed on time.
• Identifies and leads implementation of new opportunities for improvements to work processes, production, and other areas as identified.
• Investigates product/component issues by conducting failure investigations, complaint trending, and Product Inquiries.
• Other CAPA related duties as assigned

Secondary:

• Remediation activities such as performing equipment qualifications, addressing deficiencies in documentation, and other improvements related to compliance issues
• Write and execute qualification protocols, such as installation or process qualifications. Compile and analyze protocol test data
• Implement documentation 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.
• Lead and execute design changes applicable to Manufacturing Engineering needs
• Assess and Implement solutions relating to corrective and preventative actions, calibration out of tolerances, non-conformances.

Minimum Requirements

• Bachelor of Science degree, preferably in Biomedical, Mechanical, Manufacturing Engineering or equivalent with 2-5 years of related experience.
• General understanding of Good Manufacturing Practices, FDA regulations, and ISO requirements.
• Formal training and/or experience in process validations/qualifications, and statistics.

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.
• Demonstrates ability to manage complex projects and multiple priorities
• Must demonstrate ability to work well under pressure, work effectively with both employees and management and be able to facilitate resolution of complex issues.
• Computer skills including, but not limited to Microsoft Office products such as Outlook, Word, Excel and PowerPoint.
• Knowledge of statistical analysis.

Salary range: $85000 - $105000

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.