Process Engineer
Real, Hartford, CT, United States
Overview
We are hiring a Process Engineer for a medical device client in Connecticut. This role supports manufacturing operations in a regulated environment, with a strong emphasis on process validation and injection molding. The ideal candidate is hands‑on, detail‑oriented, and experienced supporting compliant manufacturing processes.
Responsibilities
Support manufacturing process development and sustaining activities.
Lead and execute process validations (IQ, OQ, PQ).
Own, optimize, and troubleshoot injection molding processes (mandatory).
Develop and maintain validation protocols, reports, work instructions, PFMEAs, and change control documentation.
Support root‑cause analysis, CAPA, and continuous improvement initiatives.
Collaborate cross‑functionally with Quality, Manufacturing, R&D, and Supply Chain.
Ensure compliance with FDA 21 CFR 820 and ISO 13485.
Requirements
Bachelor's degree in Engineering.
5+ years of process engineering experience in a regulated environment.
Injection molding experience required.
Hands‑on validation experience required.
Strong documentation, communication, and problem‑solving skills.
Desired Skills and Experience
Process Engineering, Validation, Injection Molding, Medical Device Manufacturing.
Benefits
In addition to base pay, employees may be eligible for benefits such as health insurance, health savings accounts, retirement savings plans, life and disability insurance, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change.
Equal Opportunity Employer
Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
#J-18808-Ljbffr
We are hiring a Process Engineer for a medical device client in Connecticut. This role supports manufacturing operations in a regulated environment, with a strong emphasis on process validation and injection molding. The ideal candidate is hands‑on, detail‑oriented, and experienced supporting compliant manufacturing processes.
Responsibilities
Support manufacturing process development and sustaining activities.
Lead and execute process validations (IQ, OQ, PQ).
Own, optimize, and troubleshoot injection molding processes (mandatory).
Develop and maintain validation protocols, reports, work instructions, PFMEAs, and change control documentation.
Support root‑cause analysis, CAPA, and continuous improvement initiatives.
Collaborate cross‑functionally with Quality, Manufacturing, R&D, and Supply Chain.
Ensure compliance with FDA 21 CFR 820 and ISO 13485.
Requirements
Bachelor's degree in Engineering.
5+ years of process engineering experience in a regulated environment.
Injection molding experience required.
Hands‑on validation experience required.
Strong documentation, communication, and problem‑solving skills.
Desired Skills and Experience
Process Engineering, Validation, Injection Molding, Medical Device Manufacturing.
Benefits
In addition to base pay, employees may be eligible for benefits such as health insurance, health savings accounts, retirement savings plans, life and disability insurance, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change.
Equal Opportunity Employer
Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
#J-18808-Ljbffr