Work Location & Schedule

Is the role onsite, hybrid, or remote?

• Remote / Flexible (Open to 100% remote candidates, though local candidates willing to work hybrid/onsite are also welcome)

Where is the assignment located?

• Plymouth, MN (for local/hybrid purposes, but open to remote).

What are the working hours (e.g., 8/40)?

• 40 hours/week (Standard business hours, aligned with Central Time).

Will travel be required? If so, how often and where?  No

What projects will this person support?

Global Compliance for the Client Vascular Product Portfolio, specifically supporting material compliance, environmental regulations, and restricted substance initiatives for Electrophysiology-supported vascular products (e.g., catheters, cables, and guidewires).

What does a typical day look like?

• A mix of reviewing bill-of-materials (BOMs), checking part and component data against global regulations, communicating with suppliers to track down material declarations, and logging environmental data into compliance platforms.

How would you roughly break down the work in percentages (e.g., project work, meetings, documentation, other)?

• 60% Documentation, Data Entry & Analysis (BOM scrubbing, report authoring, compliance tracking)
• 25% Supplier Engagement & Follow-up (Chasing down material declarations)
• 15% Cross-functional Meetings & Project Alignments

Who will they interact with regularly

• External suppliers and vendors, internal Product Stewardship team members, Quality Assurance, Regulatory Affairs, and R&D Engineering.

What does success look like in the first 90 days?

• 30 Days: Complete all standard Client onboarding and data privacy/regulatory training modules.
• 60 Days: Get fully up to speed on internal product compliance workflows and begin independently executing supplier outreach.
• 90 Days: Confidently navigate the reporting databases, handle regular data entry updates with minimal supervision, and successfully complete product stewardship declarations.

Candidate Profile – Required Skills & Experience

1. Complex Query Writing

• Tools/Technology: SQL, Database Queries, Advanced Excel
• Experience Level: Intermediate
• Required Skills: Ability to write complex queries and analyze large datasets.
• Key Responsibilities: Query large component and material datasets to identify and extract missing compliance details.

Web Applications & APIs

• Tools/Technology: Windchill & CMAP (Compliance Map)
• Experience Level: Intermediate
• Required Skills: Experience navigating cloud-based applications and understanding data synchronization.
• Key Responsibilities: Manage data through web-based interfaces and trigger and validate data syncs between PLM and compliance platforms.

Reporting & Compliance Documentation

• Tools/Technology: Compliance Databases (e.g., Compliance Map / Windchill)
• Experience Level: Advanced
• Required Skills: Strong experience with compliance reporting and database management.
• Key Responsibilities: Generate compliance tracking reports and prepare audit documentation for regulatory bodies.

Preferred Skills & Experience

• Relational Databases
• Tools/Technology: CMAP / Windchill
• Preferred Skill: Experience working with relational databases and managing compliance-related data.

Power Platform Applications

• Tools/Technology: Power Apps / Power Automate
• Preferred Skill: Familiarity with application development and workflow automation.

Data Visualization

• Tools/Technology: Power BI / Excel Dashboards
• Preferred Skill: Ability to create dashboards and visualize data for reporting and tracking.

Are there any certification or education requirements?

• Bachelor’s degree required (preferably in Engineering, Environmental Science, Chemistry, Materials Science, or a related technical/scientific discipline).

Does the candidate need experience in the medical or pharmaceutical industry?

• Highly Preferred. Deep familiarity with global environmental and material compliance regulations is heavily valued. The candidate should have direct experience assessing products and tracking supplier data against frameworks such as EU REACH, RoHS, EU MDR (specifically Annex I Chapter II chemical/substance requirements), and upcoming packaging regulations like PPWR.
• What systems will this person be working with daily?
• Windchill and CMAP
• What personality traits work best with your team?
• A highly organized, persistent, and details-oriented self-starter. This person needs excellent professional persistence when chasing external vendors for documentation from afar.