Sr. Engineer, Production (Technical Writer)

Getinge; Merrimack (NH); Hybrid; USD 90,000 - 130,000; Full time

Benefits offered by this job

Health Insurance

Dental Insurance

Vision Insurance

401k

Paid Time Off

Wellness Program

Life Insurance

Disability Benefits

FSAs

Parental Leave

Tuition Reimbursement

Job summary

Getinge is seeking a Senior Engineer, Manufacturing Engineering Technical Writer to lead NCR documentation, CAPA activities, and quality system improvements in a medical device environment. You will write complex NCRs, support MRB, and collaborate with Operations, Quality, and Design teams.

The role requires 5–7 years in quality systems (QMS), strong analytical and writing skills, and knowledge of ISO 13485 and 21 CFR Part 820, with a hybrid work arrangement in New Hampshire.

Qualifications

• Bachelor's degree in engineering or science or equivalent experience.
• 5–7 years of QMS experience in a medical device environment.
• Excellent problem solving, communication and writing skills.
• Experience in Medical Device Manufacturing or similar.

Responsibilities

• Write complex NCRs including investigation, disposition, actions and closure.
• Support CAPA's and MRB activities with documentation.
• Develop and maintain QA methodologies to support the NCR system.
• Collaborate cross-functionally to drive NCR completion and process improvements.
• Perform root cause analysis of failures per corrective action processes.
• Drive changes and continuous improvements within the NCR system.
• Validate content accuracy with QA, Operations, ME, and Supplier Quality.

Skills

NCR writing

QMS experience

Root cause

CAPA

Audit readiness

Technical writing

ISO 13485

21 CFR 820

Education

Bachelor's in engineering/science

Tools

MS Office

PLM Agile

Mini-Tab

Job description

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

Senior Engineer,Manufacturing EngineeringTechnical Writer, is primarily responsible for writing Nonconformance Reports (NCR's) in a manner that is consistent with the rigorous expectations of medical device auditors from various agencies. This position requires a passion for writing NCR's, understanding quality requirements, developing and improving processes to meet those requirements, driving internal efforts for root cause analysis and corrective actions, while providing day-to-day support of processes to meet our high standards of quality in producing medical devices.

Job Responsibilities and Essential Duties

In this role, you will be responsible for writing NCR's, developing and maintaining Quality Assurance methodologies to directly support the NCR system.

• Write complex NCR's, which include the investigation, product or equipment disposition, actions plans, and closure.
• Support crash carts for within the Controlled Environment (CE) as needed.
• Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet internal and external requirements.
• Provide support on CAPA's.
• Engage in in Material Review Board (MRB) activities: including defect disposition, rework and sort instructions, and documentation of nonconformances.
• Perform root cause / corrective action analysis of failures in accordance with our corrective action process.
• Drive change and continuous improvements primarily within the NCR system.
• Provide cross functional support for complex root cause investigations, risk assessments and corrective actions through the NCR or CAPA process.
• Collaborate with other Manufacturing Engineers (ME's) on problem solving and root cause analysis activities.
• Partner with ME's with specific product line production quality issues.
• Assess and mitigate risk associated with manufacturing activities related to NCR's.
• Identify, analyze and resolve product and process problems within the NCR system.
• Collaborate with quality teams, operations personnel and other stake holders to gather technical information, validate content accuracy, and drive NCR's to completion.
• Drive the reduction of product and process non-conformances.
• Collaborate with manufacturing and other cross-functional teams to drive continuous improvement initiatives within the NCR system.
• Completes assigned Manufacturing Engineering tasks related to QMS systems in a timely manner.
• Deep understanding of the Quality and Regulatory requirements within a medical device manufacturing company.

Minimum Requirements

• Bachelor's degree in engineering / science, or advanced degree, or equivalent work experience.
• A minimum of 5-7 years of Quality Management Systems (QMS) experience.
• Excellent problem solving, communication and writing skills.
• Experience in the Medical Device Manufacturing industry or similar.

Preferred Knowledge, Skills and Abilities

• Advanced writing skills that hold up to audit scrutiny.
• Advanced analytical and problem solving skills.
• High level of attention to detail and accuracy.
• Self-motivated, proactive, and comfortable working with limited supervision as skills develop.
• Exceptional computer skills, including MS Office applications (Word/Excel), PLM - Agile, and statistical software (Mini-Tab).
• Ability to work collaboratively with Production, Quality, ME, Procurement and other cross-functional teams.
• Advanced knowledge of Quality Assurance methods, such as process validation, design of experiments, statistical process control (SPC) and protocol/report preparation.
• Knowledge of ISO 13485 and 14971 and 21CFR Part 820

Supervision/Management Of Others: Potentially

Internal and External Contacts / Relationships

• Senior Engineer,Manufacturing Engineering Technical Writer,position will work closely with Operations, Quality Engineering, ME, Maintenance, Quality CAPA and Compliance, Design Quality, and Supplier Quality.

Environmental/Safety/Physical Work Conditions

• Ensures environmental consciousness and safe practices are exhibited in decisions.
• Use of computer and telephone equipment and other related office accessories/devices to complete assignments.
• Office or production environment.
• Hybrid remote work hours.
• May work extended hours during peak business cycles.
• Prolonged periods of sitting at a desk and working on a computer.
• Constantly communicating with others to exchange information.

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.

#LI-YA2

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.