Labeling Engineer

Katalyst CRO; Minneapolis (MN); In loco; USD 120.000 - 160.000; Tempo pieno

Descrizione del lavoro

Katalyst CRO is seeking a highly skilled Medical Device Labelling Engineer to lead onsite labeling activities, coordinate with offshore teams, and ensure regulatory compliance for US and EU programs. The role requires strong project management, cross-functional collaboration, and experience with FDA 21 CFR, EU MDR, ISO standards, and PLM tools.

The position emphasizes planning, coordination, and leadership of labeling implementation at customer sites, serving as primary contact between customers

Competenze

• Bachelor's degree in Engineering, Biomedical, Life Sciences, or a related field.
• 510 years of experience in medical device labeling or documentation engineering.
• Strong working knowledge of FDA 21 CFR Part 820 & 801.
• EU MDR.
• ISO 13485, ISO 20417, ISO 15223.
• Hands-on experience with PLM systems and document control tools (e.g., Windchill, Agile, SAP).
• Proven ability to work in customer-facing onsite roles and lead labeling initiatives.
• Excellent written, verbal, and stakeholder communication skills.
• Strong organizational skills, attention to detail, and ability to manage multiple priorities.

Mansioni

• Labeling Engineering & Compliance.
• Develop, review, and maintain labeling content including Instructions for Use (IFU), packaging labels, product inserts, and electronic labeling.
• Ensure labeling compliance with global regulations and standards including: FDA (21 CFR Part 801 & 820), EU MDR, ISO 13485, ISO 20417, ISO 15223.
• Support product development and lifecycle activities by providing expert labeling guidance.
• Conduct labeling risk assessments and ensure mitigation of use-related risks.
• Maintain labeling documentation, version control, and design history files as per quality system requirements.
• Participate in and support audits, inspections, and notified body interactions related to labeling.
• Onsite Labeling Lead & Project Coordination.
• Plan, schedule, coordinate, and lead labeling implementation activities for assigned product lines or Operating Units (OU).
• Develop and manage integrated EU MDR labeling plans, including activities, timelines, risks, dependencies, and opportunities.
• Ensure readiness of labeling documentation and samples for Notified Body submissions, audits, and deficiency responses within defined timelines.
• Serve as the primary labeling point of contact between the customer and company, providing interpretation of EU MDR, global regulations, and customer-specific requirements.
• Track, monitor, and adjust master schedules and priorities to ensure project milestones are achieved.
• Provide project status reporting, dashboards, and ad-hoc reports to customer and internal stakeholders.
• Cross‑Functional & Stakeholder Collaboration.
• Collaborate with Regulatory Affairs, Quality, R&D, Operations, Manufacturing, Marketing, Supplier Quality, and Core Team Leads.
• Coordinate with translation vendors, Technical Communications teams, and offshore labeling teams for final labeling execution.
• Represent labeling/graphics on change orders (e.g., IFU changes, BOM changes, PSL, packaging changes).
• Support Notified Body deficiency response drafting in collaboration with offshore teams and other functions.
• Partner with Manufacturing and Operations to ensure smooth label implementation and resolve technical issues.
• Establish and maintain working relationships with suppliers and Supplier Quality teams to support label verification activities.
• Drive customer branding alignment and assess branding impacts on labeling for assigned operating units.
• Change Management & Governance.
• Support change order development, including preparation of documents for customer labeling approvers.
• Assess change requests and manage resource allocation with offshore labeling teams.
• Review and approve project plans, SOPs, templates, and labeling standards with key stakeholders.
• Support leadership in analyzing the impact of EU MDR data or regulatory updates on labeling across products and programs.

Conoscenze

Labeling engineering

Regulatory knowledge

Project management

Onsite leadership

Customer coordination

Cross-functional collaboration

Quality systems

Regulatory audits

Formazione

Bachelor's degree in Engineering

Strumenti

Windchill

SAP

Agile

PLM systems

Descrizione del lavoro

Job Description

• We are seeking a highly skilled and detail-oriented Medical Device Labelling Engineer with experience in onsite leadership and customer coordination to support global medical device programs. The ideal candidate will have 510 years of experience in medical device labelling, regulatory compliance (US and EU), and cross‑functional project execution.
• In addition to core labeling engineering responsibilities, this role requires planning, coordination, and leadership of labeling implementation activities at customer sites, serving as a primary point of contact between the customer and offshore labeling teams. The position demands strong regulatory knowledge, project management capabilities, and the ability to work effectively in a multi‑stakeholder, fast‑paced environment.
  

• We are seeking a highly skilled and detail-oriented Medical Device Labelling Engineer with experience in onsite leadership and customer coordination to support global medical device programs. The ideal candidate will have 510 years of experience in medical device labelling, regulatory compliance (US and EU), and cross‑functional project execution.
• In addition to core labeling engineering responsibilities, this role requires planning, coordination, and leadership of labeling implementation activities at customer sites, serving as a primary point of contact between the customer and offshore labeling teams. The position demands strong regulatory knowledge, project management capabilities, and the ability to work effectively in a multi‑stakeholder, fast‑paced environment.
  

Responsibilities

• Labeling Engineering & Compliance.
• Develop, review, and maintain labeling content including Instructions for Use (IFU), packaging labels, product inserts, and electronic labeling.
• Ensure labeling compliance with global regulations and standards including:
• FDA (21 CFR Part 801 & 820).
• EU MDR.
• ISO 13485, ISO 20417, ISO 15223.
• Support product development and lifecycle activities by providing expert labeling guidance.
• Conduct labeling risk assessments and ensure mitigation of use-related risks.
• Maintain labeling documentation, version control, and design history files as per quality system requirements.
• Participate in and support audits, inspections, and notified body interactions related to labeling.
• Onsite Labeling Lead & Project Coordination.
• Plan, schedule, coordinate, and lead labeling implementation activities for assigned product lines or Operating Units (OU).
• Develop and manage integrated EU MDR labeling plans, including activities, timelines, risks, dependencies, and opportunities.
• Ensure readiness of labeling documentation and samples for Notified Body submissions, audits, and deficiency responses within defined timelines.
• Serve as the primary labeling point of contact between the customer and company, providing interpretation of EU MDR, global regulations, and customer-specific requirements.
• Track, monitor, and adjust master schedules and priorities to ensure project milestones are achieved.
• Provide project status reporting, dashboards, and ad-hoc reports to customer and internal stakeholders.
• Cross‑Functional & Stakeholder Collaboration.
• Collaborate with Regulatory Affairs, Quality, R&D, Operations, Manufacturing, Marketing, Supplier Quality, and Core Team Leads.
• Coordinate with translation vendors, Technical Communications teams, and offshore labeling teams for final labeling execution.
• Represent labeling/graphics on change orders (e.g., IFU changes, BOM changes, PSL, packaging changes).
• Support Notified Body deficiency response drafting in collaboration with offshore teams and other functions.
• Partner with Manufacturing and Operations to ensure smooth label implementation and resolve technical issues.
• Establish and maintain working relationships with suppliers and Supplier Quality teams to support label verification activities.
• Drive customer branding alignment and assess branding impacts on labeling for assigned operating units.
• Change Management & Governance.
• Support change order development, including preparation of documents for customer labeling approvers.
• Assess change requests and manage resource allocation with offshore labeling teams.
• Review and approve project plans, SOPs, templates, and labeling standards with key stakeholders.
• Support leadership in analyzing the impact of EU MDR data or regulatory updates on labeling across products and programs.
  

Requirements

• Bachelor's degree in Engineering, Biomedical, Life Sciences, or a related field.
• 510 years of experience in medical device labeling or documentation engineering.
• Strong working knowledge of:
• FDA 21 CFR Part 820 & 801.
• EU MDR.
• ISO 13485, ISO 20417, ISO 15223.
• Hands‑on experience with PLM systems and document control tools (e.g., Windchill, Agile, SAP).
• Proven ability to work in customer‑facing onsite roles and lead labeling initiatives.
• Excellent written, verbal, and stakeholder communication skills.
• Strong organizational skills, attention to detail, and ability to manage multiple priorities.
  

Preferred Skills

• Experience with labeling and graphics tools such as:
• Loftware, Bartender, P360.
• Adobe Illustrator, InDesign.
• Knowledge of UDI (Unique Device Identification) requirements and implementation.
• Familiarity with electronic labeling (eIFU) platforms.
• Experience working in an IT services, engineering consulting, or global delivery model (onsiteoffshore).
• Exposure to Cardiac Surgery or Class II/III medical devices (preferred).