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Sr. Engineer, R&D CAPA - Wayne, NJ Date: Jan 9, 2026
Location: Wayne, NJ, US
Company: Datascope Corp.
Remote Work: 0 days at home (site based)
Salary Range: $115 - $140k
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 Sr. 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.
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
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.
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Sr. Engineer, R&D CAPA - Wayne, NJ Date: Jan 9, 2026
Location: Wayne, NJ, US
Company: Datascope Corp.
Remote Work: 0 days at home (site based)
Salary Range: $115 - $140k
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 Sr. 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.
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
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.
#J-18808-Ljbffr