Sr. Engineer, Process Development - 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 development, optimization, validation, and design transfer of medical device manufacturing processes from R&D into commercial production

* This role ensures that processes are robust, scalable, and compliant with regulatory and quality standards including FDA 21 CFR Part 820 and ISO 13485.

* Leadership in process development, validation, statistical analysis, and cross-functional collaboration, with a proven ability to drive successful product introductions in a regulated environment.

Job Responsibilities and Essential Duties

Process Development

* Technical and team leadership in the development, characterization and optimization of manufacturing processes for new and existing products.

* Supports the definition and development of product requirements, specifications and working parameters using current engineering methods and technologies.

* Lead large scale process validations strategies (IQ/OQ/PQ), process characterization efforts, and statistical justification aligned with regulatory expectations.

* Apply DFSS tools (DOE, SPC, capability analysis) to improve process performance and robustness.

Design Transfer

* Responsible for the design transfer activities from R&D to Manufacturing, ensuring readiness for commercial production.

* Partner with a cross-functional team to ensure designs are manufacturable, scalable, and cost-effective (DFM/DFA).

* Support product launches, including pilot builds and ramp-to-production activities

* Ensure compliance with FDA, ISO 13485 and internal quality systems.

* Conduct and support risk management activities (FMEA, hazard analysis).

* Participate in audits and inspections, providing technical expertise and documentation support.

Cross-Functional Collaboration

* Act as the primary technical interface in a cross-functional team as a Core Team member

* Partner with Operations and Quality to enhance throughput, reduce scrap, and expand manufacturing capacity.

* Provide guidance and mentorship to junior engineers and technicians.

Continuous Improvement

* Identify and drive process improvement initiatives using Lean and Six Sigma methodologies.

* Monitor and analyze process performance metrics to improve yield, reduce scrap, and increase efficiency.

* Support CAPA investigation and implement sustainable solutions.

Minimum Requirements

* Master's (Preferred) or bachelor's degree in Mechanical, Biomedical Engineering or related technical field with 5 - 7 years of experience.

* Demonstrated experience in Process Development and Design Transfer in the medical device industry or equivalent.

* Certification in Six Sigma Black Belt 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 (Solid Works, Creo), GD&T, and tolerancing methods.

* Strong problem-solving skills with familiarity in DOE, SPC, and root-cause methodologies.

* 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.

Supervision/Management Of Others:

* Intern, Co-op, Engineer I and/or II

Internal and External Contacts/Relationships

* Interacts with others in and across departments/sites and external contacts (suppliers, test laboratories)

Environmental/Safety/Physical Work Conditions

* Responsible for understanding and conforming with the Environmental Policy to ensure that significant environmental aspects that relate to actual or…