Sr. Engineer, R&D CAPA - Wayne, NJ

Getinge Group; Wayne (NJ); Híbrido; USD 115.000 - 140.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health, dental, vision insurance

401k plan with company match

Paid time off

Tuition reimbursement

Descripción de la vacante

Getinge is seeking a Sr. Engineer, R&D CAPA in Wayne, NJ to lead complex CAPA investigations within the R&D organization.

You will guide root cause analyses, develop corrective/preventive actions, and verify effectiveness to ensure design quality and regulatory compliance. The role operates with autonomy as a technical authority, mentoring engineers on CAPA processes and regulatory expectations, while collaborating with Quality, Regulatory Affairs, and Manufacturing Engineering.

Formación

• CAPA experience in medical devices and product development.
• Experience with FDA regulations and ISO 13485 compliance.

Responsabilidades

• Lead CAPA investigations in R&D, from problem definition through implementation and verification.
• Perform thorough root cause analyses for design, verification, validation, and product performance issues.
• Develop robust corrective and preventive actions aligned with design controls and risk management.

Conocimientos

CAPA methodologies

Root cause analysis

Regulatory knowledge

Problem solving

Technical guidance

Educación

Bachelor’s degree in Engineering

Herramientas

TrackWise

Descripción del empleo

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Sr. Engineer, R&D CAPA - Wayne, NJ

Location: Wayne, NJ, US

Company: Datascope Corp.

Remote Work: 1-2 days at home (site based)

Salary Range: Salary range: $115k - $140k; 10% STIP

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 Senior R&D Engineer – CAPA Specialist is a senior individual contributor responsible for leading complex, design and/or R&D controlled QMS process related Corrective and Preventive Action (CAPA) investigations within the Research & Development organization. This role drives robust root cause analysis, corrective and preventive action development, and effectiveness verification to ensure product quality, regulatory compliance, and continuous improvement in design and development processes.

Operating with a high degree of autonomy, this position serves as a technical authority and trusted advisor to R&D teams, providing guidance on structured problem‑solving, CAPA best practices, and regulatory expectations. While the role does not include people management responsibilities, it plays a critical mentoring and coaching role within the R&D CAPA ecosystem.

Job Responsibilities and Essential Duties

• Lead and execute product design and or Design Controls process related CAPA investigations within the R&D organization, from problem definition through implementation and effectiveness verification.
• Perform thorough and structured root cause analyses for design, verification, validation, and product performance issues using appropriate analytical tools and data.
• Develop and drive robust corrective and preventive actions that are risk-based, technically sound, and aligned with design controls and risk management processes.
• Ensure CAPA documentation is accurate, complete, and compliant with FDA regulations, ISO 13485, and internal quality system requirements.
• Collaborate closely with cross-functional partners—including Quality, Regulatory Affairs, Operations, and Manufacturing Engineering—to address systemic and cross-functional issues.
• Provide technical guidance, coaching, and informal mentorship to R&D engineers and associates on CAPA processes, problem‑solving methodologies, and regulatory expectations.
• Support CAPA owners in developing realistic timelines, following CAPA SOPs, and defining appropriate effectiveness verification plans and acceptance criteria.
• Support internal and external audits and inspections by providing CAPA documentation, investigation rationale, and technical explanations.
• Maintain clear traceability between CAPA investigations, corrective actions, effectiveness checks, and related design and risk documentation.
• Identify opportunities to improve CAPA execution quality and efficiency and contribute to broader quality system and R&D process improvements.
• Serve as a technical CAPA subject matter expert within the R&D organization.
• Bachelor’s degree in Engineering or related technical discipline; advanced degree preferred.
• 5+ years of experience in R&D engineering within a medical device organization.
• Demonstrated experience managing and executing CAPA activities within product design and development.
• Strong understanding of regulatory requirements, including FDA regulations and ISO 13485.

Required Knowledge, Skills and Abilities

• Expert-level knowledge of CAPA methodologies and root cause analysis tools (e.g., Fishbone, 5 Whys, FMEA) and risk management practices.
• Strong analytical and problem‑solving skills with exceptional attention to detail.
• Ability to provide clear technical guidance and support to junior engineers without direct supervisory responsibility.
• Effective verbal and written communication skills for presenting findings across all organizational levels.
• Experience creating statistically sound sampling plans and acceptance criteria for effectiveness verification.
• Proficiency with CAPA and documentation systems; TrackWise experience preferred.
• In‑depth knowledge of medical device regulations, design control processes, and quality system expectations.

Salary range: $115k - $140k; 10% STIP

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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:

• 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
• 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.