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

Location:

Wayne, NJ, US

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

Salary Range: $120k - $135k per year depending on experience and location.

• 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 CFR 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.

• 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.
• Master’s (Preferred) or Bachelor’s degree in Industrial, Mechanical, Manufacturing Systems, Biomedical Engineering, or related technical field with 6+ years of experience.
• Certification in Six Sigma Black Belt (Preferred) or Green Belt.

• 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…