Jake Nikkila
Summary
Biomedical engineer and Quality/Risk SME with 6+ years in medical devices. Experienced in FDA 510(k), ISO 13485/14971, and CAPA-driven risk management. Proven record of cost reduction, design control improvements, and regulatory compliance in Class II and combination products.
Overview
9
9
years of professional experience
1
1
Certification
Work History
Product Development (PD) Compliance Engineering Specialist
Poly-Med Inc.
01.2024 - Current
- All previous above responsibilities
- Lead Risk Management CAPA
- Completed CAPA (start to finish) with no project delays or extensions;
- Rebuilt risk management framework and SOPs, embedding best practices that streamlined FMEAs and other risk management tools
- Developed improved FMEA and risk assessment templates, simplifying adoption and enhancing regulatory traceability
- Created and delivered FMEA training curriculum, boosting team competency and consistency across over a dozen projects and products
- Trained 150+ employees on updated risk practices and certified 12 SMEs, scaling organizational risk expertise
- Aligned statistical practices with Risk Management
- Aligned Supplier Qualifications with Risk Management
- Partnered in design control system overhaul, aligning processes with risk management principles to support 510(k) readiness
- Dedicated Quality Engineer to 2 510(k) Class II Projects
- Worked in cross functional groups of Engineers, Analytics, project managers, and external consultants
- Contributor for DVPs
- Reviewer to animal study and human clinical protocols and reports
- Reviewer to external sterilization protocols
- Attended 510(k) pre-submission meetings
QE I/II
Poly-Med Inc.
01.2023 - 12.2023
- Medical device manufacturer with novel bio-resorbable materials dedicated to innovation, design, development, and process improvement of medical devices;
- Supported cross-functional design and development team by driving quality engineering deliverables to meet regulatory and project milestones
- Served as SME for computer software validation, ensuring compliance with 21 CFR Part 11 to prepare for first PMA submission.
- Guided design and regulatory strategy for Class II and combination products, supporting PMA submissions and ensuring organized project files for regulatory review;
- Executed IQ/OQ/PQ validation protocols, ensuring equipment qualification aligned with FDA and ISO requirements;
- Served as Lead Auditor for multiple internal audits as ISO 13485 Certified Lead Auditor; Identified potential nonconformances and drove closure actions that improved compliance posture;
- Directed investigation and resolution of deviations/non-conformances through risk-based analysis, preventing recurrence and strengthening CAPA effectiveness;
- Reviewed and standardized SOPs to align with updated ISO and CFR standards, improving training compliance and audit outcomes;
R&D Engineer
Diaxamed
03.2021 - 12.2022
- Medical device startup company dedicated to improving the vascular graft market;
- Executed V&V activities for new vascular graft technologies, accelerating product development toward 510(k) submission;
- Authored and maintained regulatory documentation to support Phase Gate reviews, ensuring timely project progression;
- Generated quality control documents and procedures per 21 CFR 820 Quality System Regulation, ISO 13485 Quality Management Systems, and ISO 14971 Medical Devices – Application of Risk Management;
- Managed lab operations (staff, equipment, and materials), implementing QMS and 5S practices to improve efficiency and compliance;
- Directed project management tasks supporting new product launch, coordinating deliverables across R&D and Quality;
- Created and performed necessary lab experiments for FDA 510(k) submission;
- Collaborated with testing vendors to fulfill FDA design verification and validation requirements
Biomaterials Engineering Co-Op
BD Medical/C.R. Bard
01.2017 - 08.2018
- Integral member of cost improvement team and leader in numerous projects;
- Learned and applied principles of biomedical design;
- Followed quality manufacturing procedures;
- Collaborated with pediatric clinician to design a product, perform design validation testing to obtain 510(k) approval, and integrate a manufacturing procedure to meet design specifications;
- Spearheaded cost-reduction initiative saving $1.8M annually through optimized material selection and process redesign;
- Designed and implemented new manufacturing process, improving product yield by 69% within 3 months;
- Examined ASTM and ISO standards to define regulatory pathway and obtain 510(k) approval;
- Performed materials testing and provided recommendations to improve manufacturing procedure;
Education
B.S. - Bioengineering
Clemson University
Clemson, SC12.2019
Masters in Engineering - Biomedical Engineering
Clemson University
Clemson, SC05.2021
Skills
Risk Management (ISO 14971 Certified, FMEA, CAPA integration)
Design Control & Regulatory Submissions (FDA 510(k), PMA support)
Computer Software Validation (21 CFR Part 11)
Supplier Quality & Audits (ISO 13485 Lead Auditor Certified)
Process Validations (IQ/OQ/PQ)
QMS Standards (21 CFR 820, ISO 13485, ISO 11135)
Certification
- Risk Management (ISO 14971 Certified, FMEA, CAPA integration)
- Design Control & Regulatory Submissions (FDA 510(k), PMA support)
- Computer Software Validation (21 CFR Part 11)
- Supplier Quality & Audits (ISO 13485 Lead Auditor Certified)
- Process Validations (IQ/OQ/PQ)
- QMS Standards (21 CFR 820, ISO 13485, ISO 11135)
Internship Experience
- U.S. Army CCDC CBC Biosciences Division –Biodefense Branch (Summer 2019, January 2020 – August 2020):
- MUSIP (Minority Undergraduate Student Internship Program) Intern
- Used microneedle collection system of interstitial fluid for wearable devices research
- Performed HPLC coupled with Untargeted Metabolomics Mass Spectrometry Analysis of Pooled Human Plasma
- Performed bioinformatics research on human biological samples
- Used CAD to develop biological sample collection prototypes
Timeline
Product Development (PD) Compliance Engineering Specialist
Poly-Med Inc.
01.2024 - Current
QE I/II
Poly-Med Inc.
01.2023 - 12.2023
R&D Engineer
Diaxamed
03.2021 - 12.2022
Biomaterials Engineering Co-Op
BD Medical/C.R. Bard
01.2017 - 08.2018
Masters in Engineering - Biomedical Engineering
Clemson University
B.S. - Bioengineering
Clemson University