Timothy Good Email & Phone Number

Rocky River, Oh, Us

Trumbull, Connecticut, United States

Westlake Ohio

• Executive management leader with extensive expertise in ISO13485:2016 and 9001:2015 Quality Systems and sub processes.• Adept in Regulatory Affairs, assessing products under development, changes to existing products (510k, CE, etc.), labeling, and compliance strategies for evolving regulatory requirements.• Successfully led the revision of Blue Spark's 21 CFR 820 Quality Management System to align with ISO13485:2016, ISO 14971:2012, and IEC 62304:2006.• Demonstrated audit leadership, achieving observation-free outcomes in two 3rd party certification audits by Blue Spark's Notified Body and two Due Diligence audits for strategic partnerships with global pharma firms.• Led the compilation and submission of Blue Spark's Technical File successfully achieving CE marking.• Conducted annual Executive QMS Management Reviews and served as the lead trainer for cGMP, QSR, Complaint Handling and MDR reporting.• Provided guidance for the development and launch of new products under 13485:2016 QMS and 9001:2015 QMS.• Maintained Blue Spark's device registration and listing membership to Global Medical Device Nomenclature (GMDN) to support Unique Device Identification (UDI).

Westlake, Ohio, United States

• Successfully introduced and launched a Product Lifecycle Management (PLM) vault to efficiently manage revisions of controlled documents, such as engineering drawings, specifications, and SOPs, while ensuring proper personnel access and read/write permissions.• Supported the management of Regulatory Affairs programs, contributing to the successful rollout of Unique Device Identification (UDI) ahead of the FDA compliance date and facilitating 510k reviews.• Initiated and executed OSHA procedures for Blue Spark Battery production, conducting gap assessments, developing procedures, and training employees, leading to confirmed compliance through a third-party audit.• Co-led an initial onsite FDA QSIT inspection while leading the inspection backroom, maintaining scribe notes, and conducting Subject Matter Expert (SME) preparation in real-time, resulting in a successful inspection without Form 483 findings.• Conducted a comprehensive evaluation of the established corporate ISO 9001:2008 Quality System supporting battery design, development, and manufacturing to comply with ISO 9001:2015. Remediated identified deficiencies in procedures and records, leading to a successful 3rd party recertification without any observations.• Developed and implemented production process metrics to identify opportunities for scrap reduction through conclusive root cause analysis.

Elyria, Ohio, United States

• Led a critical company-wide project involving the remediation, compilation, and auditing of design history files for subject devices under consent decree, ensuring compliance with regulatory standards.• Oversaw the acquisition, compilation, and analysis of diverse data sources to enhance product risk assessments, encompassing complaints, adverse events, recalls, returns, service data, and non-conformances.• Recognized for exceptional performance and promoted to department lead CAPA investigator.• Developed and managed proof books and conducted mock audits to ensure comprehensive data review and identified information gaps before third-party inspections.• Key contributor in the remediation team, contributing to the development and implementation of revised design control SOPs, forms, and work instructions aligning with 21 CFR 820.• Successfully led the development and global rollout of a compliant traceability matrix format, while also assisting in the implementation and training of traceability matrix software.

Elyria, Ohio, United States

• Provided design and engineering support for Class I and II medical device product lines grossing approximately $310 million in annual sales.• Developed complex assemblies and ensured the accurate and timely release of specifications and documentation, adhering to project timelines.• Actively participated in sourcing projects to expand the supplier portfolio and successfully implemented cost-saving initiatives, targeting minimum savings of $100K+ per project.• Coordinated with functional groups in the US and abroad regarding documentation, compliance, testing, purchasing, marketing, and manufacturing activities.• Performed evaluations on return products to determine failure mode and how it is related to product design, intended use and product risk management file.• Department lead for training new hires (local & international) regarding current procedures and systems.

Elyria, Ohio, United States

• Utilized CAD design techniques, design rules, and specifications; prepared design concept layouts, assembly and detail drawings; performed calculations and developed layouts in support of product design.• Performed design tasks incorporating knowledge of equipment capabilities, application techniques, and design limitations.• Generated files for various prototyping techniques.• Coordinated with model shops to obtain models/prototypes of designs.• Worked with marketing during conceptual stages of project development.• Authored and supported the initiation of Engineering Change Notices (ECNs) and the compilation of supporting documentation.

Elyria, Ohio, United States

• Worked cooperatively with engineering teams on major improvements to existing products and the design, development, and manufacture of medical devices.• Produced detailed drawings for use in the domestic/international manufacture of existing and new products, complying with corporate quality control, and documentation standards.• Completed 200+ Engineering Change Requests (ECRs), Engineering Change Notices and design projects annually, exceeding departmental average by 220% each year.• Trained and supported international business unit staff and joint venture associates in corporate quality controls and internal company documentation standards.

Elyria, Ohio, United States

• Performed quality control and industry standard bench tests on prototypes, new devices, and existing products.• Designed and assembled custom testing platforms to verify product compliance with operational specifications and industry/regulatory standards.• Authored and distributed engineering test reports supporting R&D, Verification and Validation testing.

Elyria, Ohio, United States

• Assisted the shop manager in supervising 40+ fabrication production employees, supporting 20+ product assembly lines.• Set up and operated 30-60 ton punch presses, vertical/horizontal benders, cut-off machines, robotic welders, automated fabrication and assembly machines, and performed preventive maintenance.• Department material handler procuring all raw or in process materials via tow motor, reach truck or boom crane to ensure continuous operations.• Worked with engineering and related departments on product design changes, process control, and production schedules.• Trained associates and temporaries on quality standards, inspection methods, machine processes and company safety procedures.

Bachelor, Business Administration (Focus: Organizational Management)

Associate Of Applied Science, Manufacturing Engineering Technology/Mechanical Design