Jonathan R. Bellas
Raynham,MA
Summary
Professional with 19+ years of experience in the medical industry, skilled in product development, compliance and team management. Skilled in developing products from concept to market introduction. Adept at leading large cross functional teams, developing execution strategies and mitigating risk to ensure timeline commitments are achieved.
Overview
21
21
years of professional experience
Work History
Program Manager
Medtronic
Danvers, USA
09.2023 - Current
- Oversaw manufacturing project execution, ensuring adherence to timelines, budgets, and technical deliverables.
- Developed comprehensive project plans, monitored progress, and identified areas for process improvement.
- Guided team in strategy execution and risk mitigation to enhance project outcomes.
- Acted as liaison between manufacturing and R&D teams across different locations and time zones.
- Provided input on design/manufacturing specifications and managed risk mitigation strategies for product testing.
- Led weekly multi-site calls to discuss design, manufacturing, testing, and inspection processes.
- Communicated project status and risk management updates to senior leadership regularly.
- Collaborated with teams across departments to develop effective strategies for executing programs.
- Collaborated with functional managers to develop program resource plans and assign program resources.
Principal Product Development Engineer
Depuy Synthes Spine
Raynham, USA
07.2023 - 11.2024
- Oversaw implant design specifications, risk management, CTQs, fixturing for inspection, and product testing protocols, ensuring alignment with project goals.
- Designed, developed, and tested a new 3D printed spinal implant.
- Led weekly calls with multiple international teams regarding design, manufacturing, testing, and inspection of products.
- Communicated project status, risk mitigation strategies, and milestone tracking to senior leadership, facilitating informed decision-making.
- Engaged customers for product evaluation and feedback, enhancing product development based on user insights.
- Provided leadership and guidance to the team regarding project strategy, execution, risk mitigation, etc.
Principal Product Development Engineer
Depuy Synthes Spine
Raynham, USA
09.2019 - 07.2023
- R&D Project Leader DePuy Products – Conversion of Products from MDD to MDR Compliance
- Led the strategy and execution of R&D and quality documentation remediation for CE marked DePuy products to ensure MDD products met MDR compliance.
- Identified MDR gaps in legacy procedures/documentation and led team in executing remediation efforts.
- Executed compliance checks for all procedures and products before regulatory deadline, ensuring uninterrupted services for patients and users.
- R&D/Quality Lead for 11 BSI Submissions and responsible for written responses for all quality/R&D audit questions.
- 30 Technical Files completed (5808 SKUs), 11 Submissions that required full audit (2158 SKU’s), and $300MM dollars annual revenue protected.
- Partnered with Regulatory Affairs, Clinical and Medical operations to ensure strategy and relevant clinical evidence supported performance and clinical claims.
- Interfaced live with regulatory body auditors (BSI) for audit questions/responses and communication of DePuy’s strategy.
- Communicated project updates and risks at weekly leadership meetings (senior leadership representing all functions).
- Created and delivered MDR training sessions for R&D, Marketing, Quality, and Regulatory teams.
- Managed a large team of contractors (15-20 R&D and Quality engineers) in Agile environment.
- Conducted weekly 1-on-1 meetings with individuals and the broader team to provide a touch point where various topics could be discussed (e.g. capacity planning, risk/mitigation, development opportunities, etc.)
Staff Product Development Engineer
Depuy Synthes Spine
Raynham, USA
09.2016 - 09.2019
- Oversaw development and launch of Mesh Interbody Device implant in US and Japan, ensuring alignment with market needs and regulatory requirements.
- Led strategy and execution of audit and remediation of DHF documentation, ensuring compliance with internal and external standards by managing project milestones, technical design, team effectiveness, timeline, and financial commitments.
- Developed and executed testing strategy to support FDA.
- Facilitated discussions with surgeons regarding transition from discontinued product to new offering, covering benefits, indications, risks, and design specifications.
Staff Project Manager
Depuy Mitek
Raynham, USA
09.2012 - 09.2016
- Overall ownership of the projects (responsibility for Project Management - Milestones, Technical Design, Team effectiveness, timeline, Financial Commitments, etc.)
- Led cross functional project team (US and SWISS) and drove decision making thru the Product’s lifecycle (Feasibility thru Launch)
- Managed communication with Senior Leadership Team on milestones, risks, and project status to ensure informed decision-making.
- Conducted risk mitigation and contingency planning during the design development process to accelerate timing and reduce potential setbacks.
- Led Technical Design Reviews at each Phase of product development.
- Utilized project management tools (MS Project Timelines, Team Meeting Minutes, Mindmanger Thought Maps) to enhance team organization and alignment toward project goals.
- Utilized DEx principles and Minitab software to analyze the performance data to make design decisions and recommendations to management.
- Consulted with internal and external IP/legal teams on IP Landscape reviews and right to use decisions to mitigate legal risks.
Product Development Engineer (1-3)
Depuy Spine
Raynham, USA
07.2005 - 09.2012
- Technical Leader for Spinal implant Development and Launch – Project consisted of launching a system comprising of an inter-vertebral spinal implant, implant instrumentation, disc clearing instrumentation, and an access system.
- Drove design of implant and instrumentation, utilized FEA for design optimization, determined worst-case test pieces for 510k testing, provided technical support and rationales for FDA submission, developed test protocols, and designed instruments for functionality and usability.
- Lateral Interbody Fusion Subject Matter Expert - Provided Lateral Procedure/Product training to internal and external sales force, as well as Med Ed and the MIS group.
- Traveled to Switzerland and trained EMEA Marketing and Sales colleagues and their managers on the MIS portfolio and product offerings.
- Project Leader – managed 3 projects (built timelines, led cross functional team meetings, monitored resourcing, contingency planning, created user needs/requirements, DFMEAs, worked with Marketing on VOC collection strategy and user inputs, worked with quality on PVEs and validation requirements, R&D Lead/Reviewer on 510k submission where I provided justifications, memos, and relined multiple reviews of final submission.
- Led front end project to scope and identify new product for activation and transition to NPD.
- I led a cross functional team in the development of a business case, concepts/prototypes, and VOC strategy/collection.
- Utilized PMx tools, such as 'Definition of Done' and Work Breakdown Structure (WBS), during the planning phases of the project.
- Reviewed product development processes for enhancements and identified design controls versus business tools.
- Led 50+ Worldwide Headquarters visits where I provided product overviews and hands on cadaver labs with Surgeons.
Education
Bachelors of Science - Mechanical Engineering
Northeastern University
Boston, MA06-2002
Skills
- Project management
- Product lifecycle expertise
- Risk management
- Regulatory compliance
- DHF/DHR auditing
- Technical acumen
- Cross-functional collaboration
- Leadership and mentoring
- Effective presentations
Phone
cell, 617-966-1891
Timeline
Program Manager
Medtronic
09.2023 - Current
Principal Product Development Engineer
Depuy Synthes Spine
07.2023 - 11.2024
Principal Product Development Engineer
Depuy Synthes Spine
09.2019 - 07.2023
Staff Product Development Engineer
Depuy Synthes Spine
09.2016 - 09.2019
Staff Project Manager
Depuy Mitek
09.2012 - 09.2016
Product Development Engineer (1-3)
Depuy Spine
07.2005 - 09.2012
Bachelors of Science - Mechanical Engineering
Northeastern University