Jeff O'Hern, Pmp Email & Phone Number

Minneapolis, Mn, Us

Marlborough, Ma, Us

Working in a contract role within the IVUS group of BSC

Abbott Park, Illinois, Us

Responsible for implementing and driving operational efficiencies within the CSI International team in order to execute on timely product registrations and clinical studies for the purposes of driving overall international growth

Center Valley, Pennsylvania, Us

Brooklyn Park, Mn, Us

Adding the management of contract development and manufacturing programs to my resume. Working with our OEM clients on a variety of projects while leading an in-house team of engineers through the concept, development, and manufacturing transfer phases of product development.

Minneapolis, Mn, Us

Began as a contractor in 2016 working on a DARPA funded research project within the Neuromodulation group. Accepted a permanent position within Medtronic in early 2018; now managing a program tasked with bringing all Neuromodulation products into compliance with EU MDR.

San Clemente, California, Us

Charlotte, North Carolina, Us

Us

Currently manage multi-year program, with projected budget of $20 million, within the Payment Integrity space at Optum. Responsible for management of: - Integrating work from various areas of the organization into one program plan- Estimation of and monitoring annual budget allocations across the program- Program change control, issues, and risks - Project management team representing various work streams across program- Weekly executive level sponsor presentations

- Manage both internal and external stakeholder relationships across many countries- Responsibility of ensuring team’s adherence to various government regulations - Experience in pulling groups together across the organization to set up systems in support of international markets- Lead teams to solutions for complex product flow logistical challenges- Responsible for managing cross functional team to launch of pelvic floor repair medical products- Led team of 15 employees to launch of products which increased pelvic floor restoration revenue 30% from 2008 to 2010- Planned and monitored timeline, resources, and budget from concept through launch.- Monitored and controlled project risk process in highly regulated FDA environment.- Proficient in MS SharePoint, MS Project, and MS Visio- PMP certified

Minneapolis, Minnesota, Us

- Led the technical development efforts for 3 successful product launches in 3 years- Developed new test methodologies for use in product development efforts- Managed Design Verification builds, testing, and data analysis- Extensive background in developing validation strategies for manufacturing processes- Proficient in writing technical protocols and reports for use in documenting verification/validation results- Supervision and guidance of junior level engineering and technician staff

Hong Kong, Hk

- Redeveloped and then revalidated manufacturing processes for stent delivery system which had not met acceptance requirements of previous validation testing. - Re-validation a success and product currently on the market.- Researched and procured materials for polymer coated drug eluting stent- Devised in-vitro test plan for drug eluting stent.

New Brunswick, Nj, Us

-Managed transition of research and prototype process into validation and full scale production 2 months under deadline.-Responsible for bringing non-medical device contractor of stent coating into full GMP compliance-Implemented validation activities following extensive process development including Design of Experiments and Statistical Process Control.-Strong comprehension of all statistical tools that have reduced development timeline.-Broad experience in the writing of development and validation plans, protocols, and reports.-Successful development of automation to replace manual processes.

Marlborough, Ma, Us

Developed processes for stent delivery system, a product with yield rates amongst the highest 5% in the company.Involved in collecting all bench test data for a PMA application that was approved by the FDA in a 6-month turnaround.Personally responsible for creating and implementing Process Validation plans and protocols.Successful results with Design of Experiments, Robust Tolerance Analysis, and Statistical Process ControlExperience working with a variety of plastics, metals, and adhesives. All yearly reviews revealed above average to well above average results with a 14% salary increase earned following the year 2000.

Education record

Ma, International Business

Bs, Biomedical Engineering

Education record