Nickolas Romcevich
Longmont
Summary
Over 20 years of experience in medical technology, specializing in leading complex projects for catheters, surgical devices, biologics, and diagnostic equipment.ck record managing multi-million dollar projects from concept to market release, including ownership of five Design History Files and successful interactions with FDA and Health Canada. PMP expertise in project management methodologies, including Agile, complemented by an MBA and entrepreneurial experience in developing business plans. Strong leadership of diverse teams exceeding 20 members, ensuring adherence to a variety of quality management systems.
Overview
22
22
years of professional experience
1
1
Certification
Work History
Business Owner
K&N Consulting
Niwot
10.2013 - Current
- Manage all dimensions of business operations, including client relations, strategic planning, and financial management to foster growth and maintain delivery of high-quality consulting services.
VP of Product Development & Operations
BioMEMS Diagnostics, Inc.
Bloomfield Hills
08.2023 - 08.2024
- Refined project scope and objectives, achieving 30% reduction in project schedule through technical feasibility assessments.
- Directed development of Minimum Viable Product to enable proof of concept demonstrations.
- Collaborated with a cross-functional team to align product development strategies with organizational goals.
Sr. Product Development Program Manager
Veranex, Inc.
Providence
10.2021 - 12.2023
- Oversaw multi-million dollar projects with diverse teams, driving development of medical devices and in vitro diagnostic products for global markets.
- Achieved nearly $10M in follow-on contracts, enhancing portfolio and fostering client loyalty.
- Implemented Jira for work package management, boosting task execution efficiency by around 25%.
Project Leader/Program Manager/Interim Principal Investigator
Terumo BCT, Inc.
Lakewood
09.2016 - 08.2020
- Led a cross-functional team of 25 members across engineering, regulatory, quality, marketing, and manufacturing through the initial feasibility grant, securing a follow-on $10M contract for a PMA class III combination biologic and medical device system.
- Implemented a design change that enhanced usability and maintained equivalent functionality, effectively mitigating the risk of customer dissatisfaction and increasing the likelihood of regulatory approval.
Program Director
Precision Biopsy, Inc.
10.2013 - 02.2015
- Accelerated project timeline by six months through precise definition of user needs and requirements.
- Collaborated with stakeholders to define project milestones for optical-electrical biopsy device.
- Refined customer discovery processes to enhance project clarity and operational efficiency.
Project Director
Tensentric, Inc.
Boulder
06.2010 - 08.2013
- Managed comprehensive product lifecycles, securing over $5M in client funding.
- Oversaw design and verification processes to align with client needs and industry standards.
CEO
Anthropo Life Sciences, LLC
Niwot
05.2024 - Current
- Secured commercial license from NASA for innovative computer architecture, facilitating further development and application.
- Developed proof-of-concept drone prototypes to showcase feasibility and potential of new technologies.
CEO/Founder
NüBrü Coffee, LLC
Niwot
10.2013 - 06.2016
- Directed strategic business planning and operations, driving company growth and acquisition.
- Conducted comprehensive market research and developed brand strategies to secure key sales accounts.
- Managed financial operations, overseeing accounting, payroll, and financial reporting.
Decision Analytics Lecturer, Substitute Lecturer
University of Colorado
Boulder
01.2015 - 05.2015
- Taught linear programming models, time-series forecasting, network models, and decision trees to enhance students' understanding of complex analytical techniques.
Sr. R&D Engineer
Crosstrees Medical, Inc.
Boulder
05.2008 - 05.2010
- Secured CE Marks and 510k approval for innovative surgical instruments, including custom-designed reverse thread screw.
- Enhanced product safety and compliance through rigorous design, development, and testing processes.
Sr. R&D Engineer
FoxHollow Technologies, Inc.
Redwood City
08.2005 - 12.2007
- Engineered and created multiple 510k atherectomy catheters and related capital equipment.
R&D Engineer II
Bacchus Vascular, Inc.
Santa Clara
08.2003 - 08.2005
- Developed a printed circuit board (PCB) to effectively limit motor torque, addressing, and preventing intraoperative drive shaft fractures in thrombectomy catheters following a voluntary recall.
Education
MBA - Business Administration
University of Colorado
Boulder, CO05.2014
Master of Science - Mechanical Engineering
Stanford University
Palo Alto, CA09.2003
Bachelor of Science - Mechanical Engineering
University of California
Berkeley, CA12.2001
Skills
- Regulatory Compliance
- FDA 21 CFR Part 820
- ISO 13485/14971
- IEC 62304/60601/61010
- EU MDR and IVDR compliance
- Team Leadership & Development
- Managing interdisciplinary teams
- Mentoring and coaching high-performing teams
- Talent management and succession planning
- Program and Project Management
- End-to-end project lifecycle management
- Agile
- Waterfall
- Decision Analysis
- Product Development & Commercialization
- Class II and III medical devices
- Design Control and validation processes
- Risk management and mitigation strategies
- Financial & Resource Management
- Budgeting and financial forecasting
- Resource allocation and optimization
- Risk & Change Management
- Risk assessment and mitigation planning
- Change control processes
- Stakeholder Management
- Building alignment across stakeholders
- Senior leadership and executive reporting
- Customer and clinical stakeholder engagement
- Process Improvement & Operational Efficiency
- Continuous improvement initiatives
- KPIs and performance tracking
Certification
Project Management Professional, PMP, 3838482
Independent Patents
· Shrink-tube Medical and Protective Device: Sole inventor of US Patent No. 8968226
· Motivational Baseball Glove: Sole inventor of US Patent No. 7674195
Accomplishments
· Honors, Engineering, University of California
· Tau Beta Pi Engineering Honor Society
· Golden Key Honor Society
Affiliations
· Head Coach - Niwot Vibes competitive baseball team
· Ski Coach – L100 Certification, International Freeskier and Snowboarder Association
Timeline
CEO
Anthropo Life Sciences, LLC
05.2024 - Current
VP of Product Development & Operations
BioMEMS Diagnostics, Inc.
08.2023 - 08.2024
Sr. Product Development Program Manager
Veranex, Inc.
10.2021 - 12.2023
Project Leader/Program Manager/Interim Principal Investigator
Terumo BCT, Inc.
09.2016 - 08.2020
Decision Analytics Lecturer, Substitute Lecturer
University of Colorado
01.2015 - 05.2015
Business Owner
K&N Consulting
10.2013 - Current
Program Director
Precision Biopsy, Inc.
10.2013 - 02.2015
CEO/Founder
NüBrü Coffee, LLC
10.2013 - 06.2016
Project Director
Tensentric, Inc.
06.2010 - 08.2013
Sr. R&D Engineer
Crosstrees Medical, Inc.
05.2008 - 05.2010
Sr. R&D Engineer
FoxHollow Technologies, Inc.
08.2005 - 12.2007
R&D Engineer II
Bacchus Vascular, Inc.
08.2003 - 08.2005
MBA - Business Administration
University of Colorado
Master of Science - Mechanical Engineering
Stanford University
Bachelor of Science - Mechanical Engineering
University of California
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