Craig Fenstermaker Email & Phone Number

San Diego, CA, US

Vista, California, United States

• Program / Project Management of RUO / IVDD / IVDR / FDA facing New Product Development programs.
• Currently Program Manager for RUO New Product Development of a Medical Device – High Resolution, mid thruput digital pathology scanning solution. Owner of all Quality, Regulatory, R&D, Technical Publication and.
• Creator or contributor to multiple DHF procedures and deliverables including; User and Product Requirements, FMEAs, Verification / Validation Protocols and Reports and DHF index
• Currently R&D Project manager for FDA facing High Resolution, high thruput digital pathology scanning solution – Presub Q201XXX. Owner of all R&D DHF items. Contributor to Clinical Affairs, Quality and Regulatory DHF.
• Currently R&D Project Manager for multiple quality improvement Change Requests.

Vista, CA

• Provide relevant industry knowledge to identify and develop clinical facing products; i.e.; CDx Image Analysis Algorithms, Diagnostic Image Analysis algorithms, Primary Diagnosis of H&E Stained Tissues (Manual Read).
• Initiate and manage the successful clinical study that resulted in the FDA granting Aperio (LBS) Clearance to market the Aperio AT2 DX system for Clinical Diagnosis in the - US 510(k) K190332 (Manual Read for Primary.
• Identify clinical study partner candidates. Select and enter into contractual agreements with those selected.
• Create and submit clinical site documentation for obtaining IRB approvals.
• Contribute to Clinical Study Protocol, meet with FDA to refine Protocol for re-submission.
• Clinical Operations representative to business partners, clinical sites and investigators.

Carlsbad, CA

• Manage Healthcare IT Installations and user training
• Provide in-person and virtual product training for sales colleagues in DP core competencies including CDx and other Diagnostic / Prognostic Image analysis algorithms along with Clinical and RUO workflows.
• Develop and revise training materials for Digital Pathology (DP) Image Analysis workflow; including algorithm tuning for customer specific samples (RUO).

Greater San Diego Area

• Manage all technical support activities for Aperio’s initial FDA PMA Primary Read submission (Project Pink).
• Act as DP champion when visiting major accounts and prospects.
• Report customer VOCs to senior staff as a part of continuous product improvement.
• Collaborate with Engineering and Product Management to incorporate customer feedback into product.
• Collaborate with Training Team to ensure external customers receive appropriate DP workflow training.
• Lead sales managers with performing ROI analysis.

Greater San Diego Area

• Ascertain market size, product requirements and functionality of proposed GLP audit capability for Spectrum software within the Life Sciences market space.
• Manage product development of the GLP audit tool with cross-functional teams through product release.
• Research market size, product requirements and functionality of a proposed ScanScope Calibration Procedure software application and tooling for the Healthcare and Life Sciences market.
• Present business case and ROI to senior staff.
• Manage product development of the calibration tool with cross-functional teams.
• Ascertain market size, product requirements and functionality of a proposed Tumor Conference specific software application.

Greater San Diego Area

• Manage Evaluation Study, (try-before-you-buy), projects such that the prospect had no reason to say no at the end of the evaluation period. This required managing; study timelines, hardware / software delivery and.

Vista, CA

• Develop an IQ / OQ / PQ product and related documentation that Aperio could sell to Life Science clients interested in displaying compliance with FDA 21CFR(XXX) guidelines.
• Develop internal lab validation protocols and related documentation to assist customers interested in displaying compliance with CAP / CLIA regulations.

Greater San Diego Area

• Install DP systems; scanners, servers, viewing stations and ensure network connectivity supports the systems.
• Perform preventative maintenance and repair product as required.
• Develop and execute initial training curriculum for level 1 and level 2 distributor and customer training.
• Develop and execute product training for internal and external customers, on DP workflow including image acquisition (scanning), image management and image analysis solutions.
• Participate in creation of an initial quality system documentation including; Complaint Handling Procedure, NCMR and CAPA Procedure; Document Control Procedure.
• Lead creation of the Technical Service / Product Support Field Engineering group’s servicing documentation.

• Manufacturing / Process Engineer: Primary responsibilities included;
• Develop and Validate a LASER weld process for joining conductors in a cardiac implantable defibrillator electrode interface.
• Develop and Validate an Alignment / Hermeticity tester used to ensure proper function of the electrode interface.
• Develop layout for the Clean Manufacturing Area and validate environmental characteristics.
• Perform equipment and process IQ / OQ / PQ validation.

Greater San Diego Area

• Manage and provide product technical support to customers by serving as the primary interface between customers and the company.
• Develop and maintain internal and external customer facing training curricula and assessments.
• Train internal and external customers on device workflow and provide ongoing product technical support.
• Direct day-to-day activities of the Service and Product Support Group.
• Coordinate in-house and field service calibration, repair, upgrades (minimum required service) and other maintenance.
• Coordinate delivery and installation of Product.

Greater San Diego Area

I utilized this time to initiate and build-out a business that my partner manages on a day-to-day basis.

Greater San Diego Area

• NOTE: Cryocor / CryoGen / American Medical Systems tenure = Sep 1997 - March 2004 = 6. 5 years Primary responsibilities included;
• Managed and provided Product Technical Support to customers by serving as the primary interface between customers and the company.
• Direct day-to-day activities of the Service and Product Support Group.
• Worked closely with the Quality Affairs / Regulatory Affairs groups by implementing and maintaining a database to track product issues / complaints.
• Assisted with continuing engineering of product by working closely with cross-functional groups to improve product efficacy based on usage experience.

Greater San Diego Area

• NOTE: Cryocor / CryoGen / American Medical Systems tenure = Sep 1997 - March 2004 = 6. 5 years Primary responsibilities included;
• Vendor identification and qualification for outside processes.
• Process engineering to develop or improve manufacturing processes.
• Generating manufacturing documentation to ensure FDA compliant operations.
• Monitor animal studies for clinical development of product.
• Manage day-to-day activities of the Operations group while the VP of Operations was on leave.

Greater San Diego Area

NOTE: Cryocor / CryoGen / American Medical Systems tenure = Sep 1997 - March 2004 = 6. 5 years Supervisor, Service and Product Support Group. Primary responsibilities included;Manage and provide Product Technical Support to clients by serving as the primary interface between clients and the company.Direct day-to-day activities of the Service and Product.

Greater San Diego Area

• Manufacturing / Process Associate Engineer
• Process development and improvement to increase reliability of manufacturing processes.
• Develop and maintain Internal and External customer facing training curricula and assessments.
• Train Internal and External customers on device workflow and provide ongoing product technical support.
• Field Service Engineering duties to install / repair / calibrate equipment.
• Create manufacturing procedures, BOMs and lot history records to ensure repeatable, FDA compliant operations.Senior Operations / Developmental Engineering Technician

Greater San Diego Area

NOTE: Cryocor / CryoGen / American Medical Systems tenure = Sep 1997 - March 2004 = 6. 5 years Responsibilities included;Development and prototype manufacturing of a cryogenic source for an ablation device.Develop manufacturing processes during transfer of product design to manufacturing.

Greater San Diego Area

NOTE: Cryocor / CryoGen / American Medical Systems tenure = Sep 1997 - March 2004 = 6. 5 years Primary responsibilities included;Process development and improvement to increase reliability of manufacturing processes.Train engineering and manufacturing staff on efficient workflow techniques.Train physicians and their staff on product usage.Field Service.

Bs Coursework, Mechanical Engineering

Education record

Mechanical Engineering Program

Grossmont CC 2 semesters Mechanical Engineering program.

Education record

Education record

2 Semesters General Education classes. El Camino CC, 2 semesters General Education classes.