Sr. Engineer, Production (Technical Writer)

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.

About the Role

Senior Engineer, Manufacturing Engineering Technical Writer, is primarily responsible for writing Nonconformance Reports (NCR’s) in a manner 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.

Responsibilities

• Write complex NCR’s, including the investigation, product or equipment disposition, action plans, and closure.
• Support crash carts within the Controlled Environment (CE) as needed.
• Identify and implement effective process control systems to support the development, qualification, and ongoing manufacturing of products to meet internal and external requirements.
• Provide support on CAPA’s.
• Engage 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 on 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 stakeholders 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.
• Complete assigned Manufacturing Engineering tasks related to QMS systems in a timely manner.
• Demonstrate a deep understanding of the Quality and Regulatory requirements within a medical device manufacturing company.

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.

Skills

• 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, ISO 14971, and 21 CFR Part 820.

Supervision and Collaboration

This position will work closely with Operations, Quality Engineering, ME, Maintenance, Quality CAPA and Compliance, Design Quality, and Supplier Quality. Potentially involves supervision and management of others.

Work Environment

• 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 are 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.

Benefits

• 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.