Timothy Good Email & Phone Number

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.

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.
• 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.
• 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.
• 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