Labeling Engineer
Katalyst Healthcares & Life SciencesMinneapolis, MN
Automate your job search with Sonara.
Submit 10x as many applications with less effort than one manual application.1
Reclaim your time by letting our AI handle the grunt work of job searching.
We continuously scan millions of openings to find your top matches.
Overview
Remote
On-site
Job Description
Job Description:
- We are seeking a highly skilled and detail-oriented Medical Device Labeling Engineer with experience in onsite leadership and customer coordination to support global medical device programs. The ideal candidate will have 5 10 years of experience in medical device labeling, 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.
- 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.
- Bachelor's degree in Engineering, Biomedical, Life Sciences, or a related field.
- 5 10 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.
- 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 (onsite offshore).
- Exposure to Cardiac Surgery or Class II/III medical devices (preferred).
Automate your job search with Sonara.
Submit 10x as many applications with less effort than one manual application.
FAQs About Labeling Engineer Jobs at Katalyst Healthcares & Life Sciences
What is the work location for this position at Katalyst Healthcares & Life Sciences?
This job at Katalyst Healthcares & Life Sciences is located in Minneapolis, MN, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.
What pay range can candidates expect for this role at Katalyst Healthcares & Life Sciences?
Employer has not shared pay details for this role.
What employment applies to this position at Katalyst Healthcares & Life Sciences?
The employer has not provided this information. This may be discussed during the hiring process.
What is the process to apply for this position at Katalyst Healthcares & Life Sciences?
You can apply for this role at Katalyst Healthcares & Life Sciences either through Sonara's automated application system, which helps you submit applications 10X faster with minimal effort, or by applying manually using the direct link on the job page.