Process Engineer II

Position Summary

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.

Principal Responsibilities

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

Education / Experience 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).
•    Lean/Six Sigma knowledge preferred

Specialized Skills / Other Requirements

•    cGMP, QSR, ISO 13485 knowledge base required.
•    Knowledge of SPC, validation, and risk management tools required.
•    ASQ Certification (CQA, CQIA, CQE, Green Belt) preferred.
•    Proficiency in documentation and technical writing.
•    Effective cross-functional communication.

The pay range for this position at commencement of employment is expected to be between $87,400 – 131,100 however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.  The total compensation package for this position will also include benefits such as medical, prescription drug, dental and vision insurance, flexible spending accounts, participation in 401(k) savings plan, and various paid time off benefits, such as PTO, short- and long-term disability and parental leave, dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.

If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

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