Ken Goodman Email & Phone Number

Buffalo Grove, Il, Us

•Lead mechanical engineer on team which brought first new multi-user breast pump in 10 years from design to manufacture and product launch. •Responsible for planning, budgeting, and qualifying all design and manufacturing changes to high volume sterile disposable plastic components and packaging.•Managed international and domestic suppliers, leading design changes and product enhancements through clear communication and expectations.•Created technical documentation as part of product development including test protocols & reports, design changes, laboratory studies, product specifications based on scientific literature.•Conducted validation testing for combination product; completed IQ/OQ/PQ for custom molded components.•Wrote manufacturing and test procedures, design and purchasing specifications, BOMs, PFMEA.•Troubleshooting and solving indeterminate test results, comparing scientific literature to internal and competitive product, characterizing pump and disposable kit performance.•Evaluated specification changes requested by FDA, planned and executed testing to support those changes resulting in 510(k) approval.•Data based decision making using statistical analysis, financial analysis, international test standards

Designed, produced and validated 6 cable protectors including first ready to market product to extend usable cable life. Filed patent, received trademark, incorporated as LLC, built cost model, created business branding and social media content, created website, surveyed market for initial feedback.

Home-based parent. Completed several projects including gut rehab of landmark house.

Honolulu, Hawaii, Us

Managed and supported implementation of EHR integrated program for healthcare practices.

Westlake, Oh, Us

Brought multiple products from design to market launch. Filed for and received 510(k) approval. Led sterilization & biocompatibility validations, REACH & RoHS certification, created design control procedure linking product requirements to DV tests. Created accurate financial model showing real cost differential.

Marlborough, Ma, Us

CAPA; reduced lubricant coating scrap by isolating critical surface defects and confirmed other product passed testing. Improved balloon and stent product profiles through process development. Specified new equipment.

Caesarea, Il

Initiated and led new business segment for catheter-based development. Focus of projects was developing a concept into a prototype and turning it into a viable product. Mapped potential customer base and marketed these and other services to them. Wrote project proposals for cost, lead times and technical solutions. Built R&D assembly lab for quick turnaround of these prototypes.

Transferred electronics production from Italy to Israel by rebuilding manufacturing & QC. Solved manufacturing and design issues using statistical tools. Established databases to track status of critical product outputs and alert to significant changes. Made and tested in-vitro simulation models to validate test methods. Designed and tested next generation bladder cancer treatment machine to be more reliable, modular, and lower cost and size.

Us

Supervised quality control for all company products; drainage devices, tubing lines, and infusion products. Led CAPA teams to resolve customer complaints & Material Review Requests, established new specifications. Prepared QC department for annual audit. Specified and ordered parts for initial catheter production.

Us

QA - Planned & led process validation & production qualification for 5 catheters through product launches. Analyzed product failures, implemented CAPA, data-based decision making using statistical tools.Process Development - Led teams in transition of 3 new catheters from design through product launches.

Transfer of company’s first product, drug delivery catheter, from pilot to full scale production. Specification, development, and implementation of production fixturing. Planned & led process validation, wrote maintenance SOP’s, equipment IQ/OQ, and cleanroom practices. Developed & implemented new processes; heat forming spiral, tube printing, lubricant coating & curing.