ENG Design Engineer II

Product Engineer II

The Product Engineer or Sustaining Engineer II will engage with an experienced cross-disciplinary team to support medical device projects. The Product Engineer II will have the opportunity to participate in product/process change submissions, cost reduction research, product failure investigations, testing, verification and validation, engineering documentation and engineering change orders creation. The Sustaining Engineer is responsible for driving the Time-To-Resolution of all engineering related issues assigned to him/her either as part of supporting a project in a cross-functional team or as individual contributor.

Lead design efforts under the guidance of Senior Engineers on design change initiatives. Oversee execution of project deliverables as assigned. Interface with various departments of(locally and internationally) to drive projects forward. Work with the V&V department to create testing protocols and verification documentation as part of a product design change. Become familiar with the medical device development life cycles, manufacturing processes, and technologies.

Conduct and/or participate in brainstorming sessions to identify creative ideas and unique solutions to current medical device designs. Create specifications for device components, assemblies, packaging, and labeling. Work with Manufacturing and other Product Development engineers to ensure that products are optimally designed for manufacturing Verify that designs meet functional requirements through the performance of engineering analyses and testing. Participates in the analysis of risk as part of Risk Management activities as applicable to medical devices.

Analyze test data using statistical tools, perform in-depth interpretation of results, and generate detailed technical reports. Follow Design Control procedures and comply with requirements of 21

CFR
820 Quality System Regulations, ISO 13485 and ISO 14971 as applicable. Participates in all reasonable work activities as may be deemed suitable and assigned by management.

Requires a bachelor's Degree in Biomedical, Mechanical, Chemical Engineering or similar Engineering disciplines. 3 years of experience in the Medical Device industry. Experience as part of internships in regulated design environments a plus – specifically medical device development, Federal Drug Administration (FDA) or ISO registered. Ability to communicate effectively, both verbally and in writing. Creative thinker and problem solver. Motivated and self-starter.

Detail oriented. Excellent understanding of fundamental mechanical principles. Organized. Experience with Microsoft Office Products:
Excel, Word, Project. Ability to maintain complete confidentiality and discretion in business relationships and exercise sound business judgment.