Wayne, NJ Maquet Cardiovascular LLC
3.5 Wayne, NJ Job Details $125,000
$140,000 a year 1 day ago Benefits Commuter assistance Caregiver leave Disability insurance Health insurance Dental insurance Flexible spending account Tuition reimbursement Paid time off Parental leave Vision insurance 401(k) matching Life insurance Qualifications Defect resolution root cause analysis Quality control statistical data analysis Statistical Process Control CAD design (engineering design task) GD&T Statistical analysis Production validation processes Quality risk management Joining process implementation Quality standards in production Design controls Biomedical regulatory compliance Quality audits Root cause analysis Cross-functional communication

Full Job Description Date:

Jul 2, 2026

Location:

Wayne, NJ, US Company:

Maquet Cardiovascular LLC Remote Work:

1-2 days at home (site based)

Salary Range:

Salary range: $125k

$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 This position drives manufacturing excellence through design influence in the development, optimization and sustaining of manufacturing processes for medical devices in accordance with Getinge's Quality system and regulatory requirements (ISO 13485 and

FDA 21 CRF

Part 820). Technical authority in Design for Manufacturability (DFM), collaborating closely with cross-functional teams to ensure current and new products are scalable, robust, cost-effective, and production-ready. Leadership in cross-functional initiatives, drive strategic improvements, oversee process validations, implement continuous improvement strategies, and support commercial-scale operations. Job Responsibilities and Essential Duties Design for Manufacturability (DFM), Design For Six Sigma (DFSS) & Product Development Establish and standardize DFM and DFSS best practices, templates, and guidelines across engineering teams. Lead early design phases to influence product architecture, material selection to ensure scalability, robust manufacturability, and cost-optimized solutions Drive Design for Six Sigma methodologies (DMADV/IDOV) during product development to ensure critical-to-quality (CTQ) requirements are met. Integrate Design for Cost (DFC) principles into product and process development, ensuring cost‑effective material choices, processes, and tooling strategies. Provide technical leadership in DFM reviews, tolerance analyses, design risk assessments, and capability studies. Translate product requirements into manufacturing specifications, tooling designs, and process control strategies. Support prototype builds and pilot manufacturing, documenting design/assembly issues and implementing corrective actions. Process Development & Validation Develop and optimize manufacturing processes including molding, machining, laser processing, automated assembly, packaging, and/or sterilization workflows. Lead large scale process validations (IQ/OQ/PQ), process characterization efforts, and statistical justification aligned with regulatory expectations. Establish long‑term process capability targets, implement control strategies, and ensure audit readiness. Apply DFSS tools such as DOE, and tolerance stack‑ups to guide process optimization. Manufacturing Support & Continuous Improvement Serve as the technical escalation point for complex manufacturing challenges, driving root-cause investigations and high-impact CAPAs to closure. Lead yield improvement initiatives, cost-reduction programs, and process harmonization across multiple product families. Partner with Operations and Quality to enhance throughput, reduce scrap, optimize workflow, and expand manufacturing capacity. Lead Lean/Six Sigma initiatives targeting waste reduction, workflow optimization, and standardization. Cross-Functional Collaboration Act as the primary technical interface in a cross-functional team as a Core Team member Lead technical discussions with suppliers on component manufacturability, material selection, tooling design, and qualification of new technologies. Apply Design for Cost and Lean principles to reduce waste, optimize workflow, and lower overall cost of goods. Partner with Operations and Quality to enhance throughput, reduce scrap, and expand manufacturing capacity. Minimum Requirements Master's (Preferred) or Bachelor's degree in Industrial, Mechanical, Manufacturing Systems, Biomedical Engineering, Biomedical Engineering, or related technical field with 8+ years of experience. Proven experience in DFM, process development and product industrialization. Certification in Six Sigma Black Belt (Preferred) or Green Belt Required Knowledge, Skills and Abilities Hands-on experience with process validation (IQ/OQ/PQ), risk management (FMEA), and statistical analysis. Proficiency with CAD tools (SolidWorks, Creo), GD&T, and tolerancing methods. Strong problem-solving skills with familiarity in DOE, SPC, and root-cause methodologies. Experience with automated assembly systems, robotics, or high-volume manufacturing. Knowledge of polymer processing, metal fabrication, laser welding or additive manufacturing. Experience in Audit Readiness and Internal/External Audits with the various Regulatory bodies (FDA, TGA, PMDA, etc.) Ability to communicate within the discipline and with others who are not technically trained Ability to prioritize tasks in a fast-paced environment. The salary range for this position is between $125k

$140k per year depending on experience.

#LI-MV1 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. 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Staff Industrial Engineer, R&D - Wayne, NJ