Packaging Engineer Job at Katalyst Healthcares & Life Sciences, Buffalo, NY

  • Katalyst Healthcares & Life Sciences
  • Buffalo, NY

Job Description

Job-ID32514763Reference26-01099Remote50% Remote Job Description: The Medical Device Packaging Engineer is responsible for the design, development, validation, and continued support of sterile and non-sterile packaging systems and associated manufacturing processes. This role ensures packaging and manufacturing solutions meet regulatory, quality, sterilization, and cost requirements, while supporting product development, sustaining engineering, and operational excellence. Responsibilities: Packaging & Manufacturing Engineering: Design and develop primary, secondary, and tertiary packaging systems for medical devices. Select and qualify packaging materials (pouches, blisters, trays, cartons, labels). Support packaging line setup, equipment qualification, and process optimization. Develop and maintain manufacturing processes aligned with product and packaging requirements. Drive cost reduction and efficiency improvements without compromising quality or compliance. Validation & Regulatory Compliance: Lead and/or support packaging and manufacturing validations, including: IQ / OQ / PQ. Package integrity testing (seal strength, bubble leak, dye penetration). Distribution simulation and shelf life (aging) studies. Ensure compliance with: ISO 11607 (packaging for terminally sterilized medical devices). FDA 21 CFR 820 / QSR. ISO 13485. Applicable ASTM and internal standards. Author and review validation protocols, reports, and technical documentation.

Job Tags

Remote work

Similar Jobs

ARR Healthcare

Nurse Practitioner (NP) - Occupational Medicine in South Carolina Job at ARR Healthcare

 ...lacerations, contusions, chemical exposures, and foreign bodies Manage follow-up visits,...  ...Qualifications Graduate of an accredited NP program; South Carolina...  ...Charleston, providing convenient access to major medical centers, cultural amenities, and... 

ECare Medical Group

Foreign Medical Graduate Job at ECare Medical Group

 ...Job Details Can Accept Applicants from Residents of Mexico and Canada. Physician who received a basic medical degree from a medical school located outside the United States and Canada that is not accredited by a U.S. accrediting body, the Liaison Committee on Medical... 

Sam's Club

Independent Optometrist - Sam's Club Job at Sam's Club

 ...Independent Optometrist - Sam's ClubIndependent Optometrist Sam's Club Launch your services in Sam's Clubs! As an Independent Optometrist leasing space inside our Sam's Club, you will take a leading role in patient care with respect to eye and vision care as well as... 

Covert Bee Cave

Automotive Chrysler Certified / Diesel Technician Job at Covert Bee Cave

 ...busiest automotive dealership groups in the region where your employer treats you like a member of the family? We are hiring Automotive Chrysler Certified Techs / Diesel Technicians. There has never been a better time to advance your career as an automotive technician /... 

Partnership for Children of Cumberland County

Human Resources Manager Job at Partnership for Children of Cumberland County

 ...Human Resources Manager Partnership for Children of Essex (PCE) is seeking an experienced and motivated Human Resources Manager to join our team. This role is ideal for a seasoned HR professional who enjoys working in a fast-paced, people-focused environment and is...