Process Engineer II

Teleflex•Mansfield, MA

13d•Onsite

About The Position

The Process Engineer shall be hands-on engineering role supporting medical device manufacturing with focus on validation, process development, and continuous improvement across sites. Includes strong emphasis on design quality, compliance, and process control. OEM – Teleflex Medical OEM is a leading global provider of product development and production services for medical device manufacturers. We set ourselves apart with deep expertise, decades of experience, a dedication to design for manufacturability, and extensive, in-house capabilities, which include engineering, regulatory services, material selection and formulation, prototyping, manufacturing, assembly and packaging. We deliver industry-changing innovations and next-generation solutions for extrusions; diagnostic and interventional catheters; balloons and balloon catheters; sheath/dilator sets; specialty sutures, braids and fibers; and bioabsorbable sutures, yarns and resins. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.

Requirements

Bachelor’s Degree in Engineering, Chemistry, Physical Science, or related field is preferred or 3+ years of Quality Assurance experience working in the medical device manufacturing environment (a combination of education and experience will be considered).
cGMP, QSR, ISO 13485 knowledge base required.
Knowledge of SPC, validation, and risk management tools required.
Proficiency in documentation and technical writing.
Effective cross-functional communication.

Nice To Haves

Lean/Six Sigma knowledge preferred
ASQ Certification (CQA, CQIA, CQE, Green Belt) preferred.

Responsibilities

Drive continuous improvement initiatives focused on enhancing product quality and reliability.
Lead process validation (IQ/OQ/PQ) and ensure compliance with FDA QSR and ISO 13485.
Ensure proper equipment qualification and calibration strategies.
Develop and maintain Control Plans, pFMEAs, and Risk Management Files.
Drive design for manufacturability (DFM) and design transfer activities.
Implement statistical process controls (SPC) and monitor process performance.
Establish and maintain CAPA inputs from process trends and deviations.
Lead root cause analysis and implement corrective and preventive actions (CAPAs) to address non-conformances and improve process performance.
Support design control activities including design inputs/outputs and verification.
Collaborate with R&D on design changes and ensure proper change control is followed.
Maintain traceability between user needs, design inputs, outputs, and verification.
Maintain Design History File (DHF) contributions for manufacturing.
Support Device Master Record (DMR) and Device History Record (DHR) accuracy.
Drive cross-functional alignment between Engineering, Quality, and Manufacturing.
Ensure manufacturing processes comply with regulatory and quality system standards, including FDA, ISO 13485, and other relevant industry regulations.