Peter Sun
PMP, PE, CSSBB, CQE, CRE
PMP & PE-certified engineer with 10+ years delivering Class II/III medical devices from concept through regulatory approval.
Proven track record: $150K+ cost savings through FEA simulation, 80% increase in client inquiries via strategic web solutions, and FDA clearance for life-saving LVAD technology.
About Me
Peter Sun | PMP, PE, CSSBB, CQE, CRE
M.S. Mechanics of Solids, Brown University
B.S. Mechanical Engineering, Boston University
I solve the hardest problems in medical device development—the ones that cost companies millions and delay patient care.
What I Do:
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Get devices approved: Led Class III LVAD through FDA IDE approval (Q1 2024) by establishing PMO infrastructure and managing cross-functional teams through complex regulatory pathways
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Save development costs: Reduced prototyping expenses by $150K+ using FEA simulation (Abaqus, FE-SAFE) for fatigue analysis of titanium implants
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Accelerate time-to-market: Streamlined EU MDR compliance workflows, improving team efficiency by 35% through portfolio dashboards and standardized processes
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Design that works: Created 50+ custom orthopedic implants (knee, hip, wrist) validated through cadaver studies and surgeon collaboration
Technical Expertise:
CAD (Creo, SolidWorks) | FEA & Fatigue Analysis | GD&T | DFM/DFA | CUDA Programming | ISO 13485 | 21 CFR 820 | Design Controls | Risk Management (ISO 14971)
Business Impact:
Whether you need regulatory strategy, mechanical design validation, or PMO setup for your next medical device launch, I bring engineering rigor and business results.
Who I Work With
1
Medical Device Companies
Companies seeking regulatory expertise for FDA/EU MDR submissions, design control implementation, or PMO establishment for complex device programs
2
Orthopedic & Surgical Device Manufacturers
Manufacturers needing mechanical design, FEA validation, custom implant development, or design-for-manufacturing optimization
3
Startups & Innovators
Startups & Innovators requiring end-to-end product development from concept through verification/validation, with cost-conscious prototyping strategies
4
Service Businesses
Businesses looking for web development, SEO optimization, and digital solutions that drive measurable customer acquisition
Results That Matter
Measurable impact across medical device development, regulatory compliance, and digital solutions. These aren't just project outcomes—they're proof that rigorous engineering, strategic planning, and cross-functional leadership deliver bottom-line results for clients and patients.
$150,000+
Cost savings through FEA simulation, eliminating physical prototypes for elbow prosthesis fatigue validation
FDA Approvals
Led Class II & III Medical Device development from concept through IDE approval, clinical trials, and launch
100+
Custom orthopedic implants designed for complex surgeries with successful patient outcomes
35%+
Improvement in execution efficiency through standardized workflows and portfolio management systems
40%+
Increase in local patient traffic and phone inquiries through on-page SEO and UX optimization (Woodbridge Pharmacy & LA Condotel)
Featured Projects
From life-saving cardiac devices to custom orthopedic solutions, my portfolio spans the full medical device lifecycle—regulatory compliance, mechanical design, FEA validation, and digital product development.
Each project delivered measurable impact: cost reduction, faster approvals, or improved outcomes.
Established PMO and led cross-functional teams to secure FDA IDE approval (Q1 2024) for life-saving heart device—from concept through clinical trials.
Created comprehensive knee replacement system with FEA analysis, cadaver validation, and ASTM testing—delivering cost savings and enhanced surgeon experience.
Designed patient-specific knee and hip implants for complex anatomies—collaborating directly with surgeons to achieve successful surgical outcomes.
Optimized constraint levels for ligament-compromised patients using 3D scanning and structural analysis, consulting manufacturer on enhanced insert design.
Developed Abaqus fatigue model simulating 3M+ cycles for titanium prosthesis, eliminating physical prototypes and saving $150K in testing costs.
Designed patented wrist-spanning plate and surgical instruments, accelerating timelines through FEA-driven prototyping and DFM collaboration.
Developed innovative UV-protective IV delivery system for chemotherapy and nutrition, managing specifications, suppliers, and Class II MDR compliance.
Led regulatory rebaseline for IV administration sets, improving team efficiency 35% through standardized workflows and portfolio dashboards.
Created LA Condotel website tailored to guest experience and mobile bookings, increasing visibility and inquiries by 80%.
Designed and optimized Woodbridge Pharmacy website, boosting local patient traffic 40% through SEO, UX improvements, and bilingual content.
Built end-to-end sports event web platform from concept to launch, defining core features and driving user growth through iterative design.