Todd Bjork
Ergotron Inc.
Hudson,WI
22
years of professional experience
Dynamic Director of Global NPD with expertise in strategic planning and cross-functional alignment. Proven success in driving innovative solutions and ensuring regulatory compliance, delivering high-quality OEM devices on time.
Work History
Director of Global NPD
3 Years 11 Months- Direct the global New Product Development (NPD) Engineering, Quality, Project Management Operations across US and China locations, delivering custom OEM devices from initial concept to commercial production.
- Drive cross-functional alignment across Engineering, Quality, Project Management and other Custom Business Units to streamline product release cycles and eliminate critical path delays.
- Oversee the customer quality processes, root cause analysis, and corrective action implementations, ensuring high customer satisfaction and strict adherence to quality metrics.
- Mitigate technical and schedule risks using comprehensive contingency planning, maintaining on-time product launch deliveries across the OEM Global teams.
R&D Engineering Manager
13 Years 3 Months- Led multi-disciplinary engineering, custom instrument design, and prototype machine shop teams in the development and release of proprietary spinal instruments and surgical instrumentation.
- Managed the full Design History File (DHF) lifecycle, ensuring compliance with FDA, ISO, CE, GLP and GMP requirements.
- Supported clinical validation efforts by participating in surgical case coverage, cadaver lab testing and direct physician training for new surgical implants and instrument systems.
- Direct oversight of machine shop operations, internal prototyping, internal instrument repair, vendor outsourcing, and GD&T inspection procedures.
R&D Engineering Manager
3 Years 4 Months- Managed R&D budget, project timelines, and personnel to deliver surgical retractor platforms from prototype through production release, ensuring alignment with strategic goals.
- Partnered with the Quality and Regulatory team to write and update departmental procedures to be compliant with the evolving FDA guidance.
- Collaborated with key opinion leaders (KOLs) and surgeons in clinical settings and O,R,s to translate user needs into technical specifications.
- Partnered with patent attorneys on patent strategies, licensing and new IP submissions.
R&D Engineer
1 Year 1 Month- Led development of innovative spinal surgery solutions, enhancing product effectiveness and patient outcomes.
- Collaborated with cross-functional teams to streamline design processes, improving time-to-market for new products.
- Conducted extensive research on biomechanical properties, informing material selection and design optimization strategies.
- Mentored junior engineers in best practices for R&D procedures, fostering skill development and knowledge sharing.
General Manager
11 Months- Managed all aspects of operations, administration, finance, and product development in an early-stage medical device startup.
- Partnered with the University of Minnesota to design GLP animal study protocols.
- Generated case study data and worked with legal and regulatory resources to create FDA 510(k) submission.
Education
Associate of Applied Science - Machining Tool And Die, CNC Programming
Skills
Legal and regulatory compliance
Strategic planning
Budget management
Business development
Decision-making
Product lifecycle management
Team management
Employee development
Goal setting
Regulatory strategy
Partnerships and alliances
Timeline
Director of Global NPD
Ergotron Inc.
09.2022 - CurrentRead More
R&D Engineering Manager
Spineology Inc.
06.2009 - 09.2022Read More
R&D Engineering Manager
Omni-Tract Surgical
08.2006 - 12.2009Read More
R&D Engineer
Spineology
06.2005 - 07.2006Read More
General Manager
Pneumedics Inc
06.2004 - 05.2005Read More
Dakota County Technical College
Associate of Applied Science from Machining Tool And Die, CNC Programming
Read More
Patents and Innovation
Named inventor/co-inventor on 40+ US and European Patents covering surgical instrumentation, spinal implant devices, and mechanical design systems.