Staff Industrial Engineer, R&D - Wayne, NJ

Getinge•Wayne, NJ

2d•$125,000 - $140,000•Onsite

About The Position

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). This role serves as the 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. The position also involves leadership in cross-functional initiatives, driving strategic improvements, overseeing process validations, implementing continuous improvement strategies, and supporting commercial-scale operations.

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.
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.

Nice To Haves

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

Responsibilities

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.
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.
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.
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.