Senior Development Engineer Resume Fort Wayne, IN - Hire IT People

SUMMARY

Resourceful, self - motivated Engineering Professional with demonstrated success in existing and new product development and launch.
Possesses excellent problem-solving skills and analytical skills. Builds and maintains strong working relationships.
Leads and manages projects and resolves product design and manufacturing issues to achieve company goals and deadlines.

TECHNICAL SKILLS

PROFESSIONAL EXPERIENCE

Confidential, Fort Wayne, IN

Senior Development Engineer

Responsibilities:

Led design and development efforts with internal Avalign team (project manager, R&D engineer, design quality and German manufacturing team members) and customer R&D team from inception of project to production run to finalize instrument designs and complete design control documentation. Participated in surgeon team usability and design validation labs to validate instruments for final production.
Worked closely with customer to develop and manufacture plantar plate instruments for a surgeon team limited production launch. Work entailed interpreting customer design requirements, review of CAD models and prints with German Quality and manufacturing teams to successfully launch product.

Confidential, Noblesville, IN

Product Development Engineer, Research & Development

Responsibilities:

Led a development project to introduce a new LCD screen in a video laryngoscope. Managed the project timeline, reported the status of milestones to the management team and made sure the project stayed on track. Coordinated with a local development firm to update the PCBA and the coding for the board chips to run the new LCD. Developed test protocols and carried out bench top and design verification tests and completed test reports. Initiated and maintained design control documents (design inputs, DFMEA) for the design history file.

Confidential, Warsaw, IN

Senior Development Engineer

Responsibilities:

Developed and launched TransFx MRI external fixator system. Led project from initial development to product launch, partnering closely with Research, Brand Management, Purchasing, Manufacturing, Quality, and Planning. Successfully worked with consulting radiologist, conducting all required MRI testing in accordance with ASTM standards.
Initiated, developed, and successfully completed D.O.E. study to mitigate corrosion found during development of targeting guide instruments for a new intramedullary nailing system. Collaborated closely with manufacturing to select optimal laser etch setting that reduced effects of corrosion, and received buy-in on final changes from project team. This change was then applied across the board to all targeting guides that were introduced with the new nails.
Based on the latest European Union (EU) Medical Device Directive (MDD), collaborated with team of Regulatory Affairs specialists and Quality Assurance engineers to update Risk Analysis documents for older Trauma products, meeting BSI’s (current European regulatory body) required deadline.
Investigated, troubleshot, and resolved product complaints in a timely manner, helping reduce number of complaints from the field by working closely with Research, Quality Assurance, Manufacturing, and various suppliers to address and resolve design issues.

Confidential, Mahwah, NJ

Project Manager

Responsibilities:

Participated in regular meetings with U.S. Marketing and Swiss R&D on development of 2 locking plating systems, and assisted in various engineering activities for the R&D team, such as summarizing test reports and writing engineering rationales for Regulatory Affairs, resulting in launch of new products in the U.S.
Collaborated closely with a designer and a consulting professor to develop a new external fixator clamp to treat severely comminuted fractures. Coordinated and took part in mechanical testing, ensuring clamp could withstand worst-case clinical loading conditions. Re-designed clamp based on test results to meet internal acceptance criteria. FDA reviewed clamp 510k submission and gave approval to sell product in the U.S.

Confidential, Ann Arbor, MI

Assembly Engineer, Prototype Development

Responsibilities:

Identified design issues during prototype builds and followed up with designers, ensuring countermeasures were adopted and issues could be closed in a timely manner.
Conducted virtual prototyping evaluations and followed up with designers, improving designs and ensuring changes were adopted in time for pilot builds at manufacturing plant.
Visited Japan several times for training on conducting prototype evaluations, reporting and communicating results, and following up with engineers to get timely design replies.