Jim Sheppard Email & Phone Number

* Established cost effective manufacturing strategy and built strategic vendor relationships* Reduced GTM time by meeting FDA and ISO quality systems requirements and compliance and by strengthening Software Validation procedures* Created Organizational development plan to build a high performing team

Wilmington, Ma, Us

* Directed a 225-member operation, overseeing Production, Engineering, Supply Chain, EH&S, and Customer Service with indirect oversight of HR, Accounting, and QA, optimizing site performance for medical and dental sterilization products* Achieved 97% on-time delivery (up from 70%) by implementing targeted process improvements, greatly enhancing customer satisfaction and reliability* Reduced quality non-conformances by 50% and inventory levels by 33%, resulting in significant cost reductions and streamlined supply chain efficiency* Surpassed cost improvement goals through strategic budget oversight and continuous process enhancement, driving sustainable cost efficiencies* Minimized recordable injuries by 60% by strengthening safety protocols and promoting a culture of workplace safety across all departments

Minneapolis, Mn, Us

SR BP Program Director – Medicrea Integration-Littleton, MA* Spearheaded operations integration for an acquired French-based firm specializing in patient-specific spinal rods, streamlining production to align with U.S. manufacturing standards* Directed a high-impact cross-functional program transferring manufacturing processes from Lyon, France, to a U.S.-based facility, accelerating production efficiency and ensuring adherence to regulatory standards* Developed and implemented a sterile packaging and steam sterilization process, ensuring compliance and reducing turnaround time to meet strict five-day delivery windows for customized products

Minneapolis, Mn, Us

* Drove performance improvements across 175 contract manufacturers, focusing on Quality, Delivery, Manufacturability, Continuity, and Cost, achieving a measurable reduction in backorder volume* Reduced backorders from $5M to $1.5M, surpassing company targets and ensuring product availability while maintaining quality standards* Led a cross-functional team of Senior Managers within a matrix organization to achieve targeted goals, leveraging strategic alignment across the larger RTG operations network* Enhanced operational efficiency by implementing standardized monitoring protocols, significantly boosting contract manufacturing performance across critical KPIs

Minneapolis, Mn, Us

* Directed a 60-member operations team and led a 150-person site, managing Production, Manufacturing Engineering, New Product Introduction, and Materials; oversaw cross-functional operations including R&D, HR, Regulatory, and Quality* Increased production capacity for 3D Imaging X-rays for spinal and cranial surgery within one year, while reducing costs by 12% and Corrective and Preventive Actions (CAPAs) by 65%* Optimized cross-site operational alignment and production workflows by integrating a secondary site with 175 employees manufacturing ENT surgery sponges* Drove the introduction and scaling of new product lines, ensuring seamless transition from R&D to full production, while maintaining regulatory compliance

Fridley, Minnesota, Us

* Directed a 300-member cross-functional team (Production, Engineering, Materials, EH&S, HR) with accountability for $135M in revenue and a $75M operational budget, optimizing resource allocation and cross-departmental alignment* Implemented Six Sigma principles, Root Cause Analysis, and Mistake Proofing to achieve a $1M reduction in overhead costs resulting in sustained annual cost reductions of 3.5-4%* Renewed critical defibrillation electrode manufacturing processes, aligned with PMA submission requirements, and strengthened product compliance and safety* Led a culture shift driven by continuous improvement, error reduction, operational efficiency, and a quality-driven environment across all plant operations

Fridley, Minnesota, Us

* Spearheaded plant operations of 200+ team members across Production, Engineering, Materials, EH&S, and HR, supporting $120M in revenue and a $35M operating budget, while driving improvements in financial and operational metrics* Delivered a 15% cost reduction and eliminated operational variances by implementing targeted LEAN and Kaizen initiatives, enhancing plant efficiency and profitability.* Developed and executed a three-year strategic plan, achieving compliance excellence with zero FDA 483 observations during inspection* Reduced backorder volume by 30%, optimizing product availability and aligning production with customer demand through strategic resource planning and workflow improvements

Burlington, Massachusetts, Us

* Created manufacturing strategy, budgets, and processes for Hyperspectral Imaging products, ensuring on-time commercialization and meeting all FDA and ISO13485 standards for an early-stage startup company* Created strategic supplier partnerships, creating performance metrics and formalized agreements* Led cross-functional teams to commercialize new products improving product performance and revenue by 200%* Implemented new ERP and CRM (Salesforce) system improving order efficiency, cost controls, and customer satisfaction

* Led Manufacturing, Planning, Service, Quality, and Regulatory domains* Developed, implemented and managed an outsourced manufacturing strategy for both medical disposables and capital equipment* Managed final assembly and test function in-house* Developed and managed Quality Systems, achieving ISO 9001 certification and product CE marks* Negotiated strategic partner agreements with Japanese and US distributors* Continuously improved quality and cost metrics through Lean manufacturing program

Us

Created and directed a new manufacturing operation, which produced Class III cardiology implants. Responsibilities included Manufacturing, Materials Planning, Distribution, Process Engineering, and Facilities. Built new Facilities including Class 10,000 clean room, hired new manufacturing personnel, and implemented new Quality Systems, and PC based MRP and Cost Accounting system.

Murray Hill, New Jersey, Us

Electrophysiology Division (Tewksbury, MA 1990-1994)Developed and directed a 150 person manufacturing organization supporting $45 million in worldwide sales. Products included Electrophysiology catheters and systems, and OB/Gyn instruments. Responsibilities included: Manufacturing, Materials Planning, Process Engineering, Quality Control, Plant Accounting and Facilities. Through the implementation of Lean Manufacturing techniques, reduced labor and inventory costs by 40%. Other positions of increasing responsibility