Sr. Engineer, Process Development - Wayne, NJ

Getinge•Wayne, NJ

1d•$115,000 - $135,000•Onsite

About The Position

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.

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
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.
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.

Responsibilities

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.
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.
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.
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.