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

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 provides technical leadership 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).

* This individual is a key resource during 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 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 6+ years of experience.

* Certification in Six Sigma Black Belt (Preferred) or Green Belt

Required Knowledge,

Skills and Abilities

* Demonstrated expertise in Design for Manufacturability (DFM) principles and tools.

* Hands-on experience with process validation (IQ/OQ/PQ), risk management (FMEA), and statistical analysis.

* Proficiency with CAD tools (Solid Works, 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 $120k - $135k per year depending on experience and location.

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