Engineer I, Production

Getinge; Wayne (NJ); Hybrid; USD 88.000 - 92.000; Vollzeit

Benefits dieser Stelle

Health insurance

401k with company match

Paid Time Off

Wellness initiative & Health Resources

Life Insurance

Disability benefits

Flexible Spending Accounts

Commuter Benefits

Parental and Caregiver Leave

Tuition Reimbursement

Zusammenfassung

Getinge is seeking an Engineer I, Production in Wayne, NJ, to review production documentation, validate processes, and drive improvement projects. The role supports compliance with regulatory standards and quality systems while collaborating with manufacturing engineering leadership.

Ideal candidates hold a BS in engineering with up to 2 years of related experience, familiar with GMP/FDA/ISO, and able to contribute to validation activities and CAPA efforts in a hybrid workplace.

Qualifikationen

• Bachelor’s degree in engineering; 0–2 years of related experience.
• GMP/FDA/ISO understanding preferred.
• Experience in a regulated environment preferred.
• Windchill experience a plus.
• Process validations/qualifications and statistics training/experience a plus.

Aufgaben

• Review production documentation and address deficiencies.
• Write and execute validation protocols; analyze protocol data.
• Review procedures and implement changes as needed.
• Ensure compliance with Quality System Procedures, GLP, and exposure controls.
• Support compliance with FDA MDR EUMDR and related regulations.
• Assess and implement corrective/preventative actions and calibration issues.
• This role is hybrid; some days in office in Wayne, NJ.

Kenntnisse

Technical ability

Analytical thinking

Communication

Organizational skills

MS Excel

Statistical analysis

Project management

Ausbildung

Bachelor’s degree in Biomedical/Mechanical/Manufacturing Engineering or equivalent

Tools

Windchill

Jobbeschreibung

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.

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, Production position will be reviewing production documentation and addressing deficiencies found, performing equipment qualifications, and other improvements related to compliance issues. Lead and execute process validation requirements in parallel with identifying and implementing improvement and cost elimination projects for manufacturing. This position will report to the Supervisor, Manufacturing Engineering.

Job Responsibilities And Essential Duties

• 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 Regulation (MDR) and European Union Medical Device Reporting (EUMDR), Alternate Summary Report (ASR), and applicable regulations and regulatory governing standards.
• Assess and Implement solutions relating to corrective and preventative actions, calibration out of tolerances, non-conformances.
• This is not an inclusive list of job responsibilities.

Minimum Requirements

• Bachelor of Science degree, preferably in Biomedical, Mechanical, Manufacturing Engineering or equivalent with 0-2 years of related experience.
• General understanding of Good Manufacturing Practices, FDA regulations, and ISO requirements.
• Experience working in a regulated environment preferred
• Experience with Windchill software a plus
• Formal training and/or experience in process validations/qualifications and statistics a plus.

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.

This role is a hybrid position based in Wayne, NJ with a few days a week required in office.

Pay rate: $88,000 - $92,000 / year + 8% annual bonus

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.