Build in-house design verification testing systems and infrastructureDevelop and validate drug delivery systems test methods Execute engineering and design verification testing to support health authority filings, e.g., NDA, CTA

• Lead in-house commercial design verification of direct-to-safety syringe Vutrisiran program, including: - Functional testing - Accelerated and Real Time performance - Statistical analysis - NDA technical support; approval June 2022• Hire and train technical talent

• Combination product development - Establish in-house test methods, fixture design, method validation and Design Verification for PFS and safety system drug delivery devices.• Implemented paradigm-breaking in-house design verification lab. • Start-to-finish design verification for Vutrisiran direct to safety syringe clinical program.

• Drove Design for Manufacturing/Assembly for 10+/-MM units/yr large volume high viscosity patch injector program• Developed manufacturing processes and requirements for large molecule autoinjector programs; worked with teams to socialize robust development tools: DFM, formal risk management, design edge of failure analysis, gaging studies, tolerance analysis, product and process CTQs• Resolved high value CMO process risks through equipment and process improvements in existing $3B portfolio • Lead engineer for 600K units/yr external manufacture of Avonex pens; investigated and addressed root causes of equipment and PFS/pen component issues; $1.2B commercial sales• Developed/implemented CMO process to reliably relabel vials for five billion IUs Alprolix/Eloctate donation under extreme time constraint

• Developed superior ACL reconstruction adjustable suture loop button implants – project lead – est $20MM/yr• Led international commercialization team for fixed-loop button-textile ligament repair device – $10MM/yr• Inspired / developed 3-5 engineers on independent projects - hiring, feedback, performance management, promotion.• Portfolio Steering team –ranked needs and programs for $500MM product development pipeline.• Led Mitek’s R&D Culture Initiative – foster employee engagement & functional relationships Mitek.• Pitched, chartered & led disposables kit project based on clear user needs and business case ~$5MM/yr.

New Product Development (R&D) – Knee repairs – Project Leader | 2011 – 2012• Led $15MM bio-absorbable interference screw development program; international team of 13.• Turned around ‘Team in turmoil’ – in 3 months, re-established rapport in a team of 12, restored management confidence in team, and delivered to critical project timeline.• Managed 3 engineering direct reports; goal setting, feedback, performance management, promotion• Created Mitek R&D Culture Team - envisioned and initiated in 2010: increased engagement across 70 person unit, improved intra-R&D relations and increased retention via team building, group branding & recognition.New Product Development –Arthroscopy Equipment – Project Leader | 2010 – 2011• Addressed unmet usability and performance needs with game-changing, disposable, arthroscopic RF electrode. ($20MM/yr); led international, multi-company team of 14.• Managed 3 engineering direct reports on independent electromechanical projects; promoted 2.New Product Development –Shoulder repairs – Project Leader | 2005 – 2009• Revitalized Mitek shoulder anchor business by launching PEEK and biocomposite (PLGA/TCP) anchor projects. for RC and instability repairs; led international team of 10; Healix and Gryphon anchors, $25MM/yr.• Revolutionized RC suture passing with ExpresSew II reusable arthroscopic passer, $15MM/yr. New Product Development – Tissue management | 2003 – 2005• Established validated assembly/inspection process for novel RetroJet water jet disposable surgical device.• Overcame textbook barriers and built/tested concepts of autoclavable 20 ksi surgical fluid jet pump.

• Implemented lean flow on MicroSeal Adaptor line resulting in 400% throughput improvement.• Owned assembly process and mitigated production issues for GuardWire, MicroSeal Adaptor and Export catheter assembly lines.

New Product Development Engineer - Endovascular Implantable Devices | Warren, NJ | 2001-2002• Validated cutting/finishing/inspection process for $70MM/yr Palmaz Genesis balloon expandable stent project.• Developed innovative LASER cutting method to overcome historic tooling limitation for new stent.Process Engineer– Endovascular Stent and Catheter Delivery System Assembly | Miami Lakes, FL | 1999-2000• Led SMART NITINOL stent manufacturing engineering team through growth from $20MM to $120MM– 4 direct reports.• Designed and validated catheter trimming tooling that reduced scrap by greater than $500M annually.• Improved stent crimping yield from 85% to 93% ($300M / year) on a Process Excellence team.